945 Quality Audit Jobs - Page 21

KRA's: Ensure SOPs are followed & quality standards are met Quality check of raw materials, in-process & finished goods on a FIFO basis QMS Implementation Audit Documentation Audit facilitation - Internal/ external & 3rd party/ regulatory audits Required Candidate profile 5+ years of experience in Quality [quality inspection, auditing, testing, reporting] in a pharma/ medical device mfg. co Ready to relocate to Medchal, Hyderabad Accommodation & food will be provided Perks and benefits Accommodation and Food provided

Hiring for SBI Capital Securities Designation: Client Activation (Quality Analyst) Location: Delhi NCR/NOIDA/GURGAON CTC: Upto 5lpa Reportees: Individual role Role & responsibilities Responsible to map clients internally as per the assigned quality parameters. Responsible to analyze new Client Quality. Being a strong link between the Sales and the Dealing team to ensure client activation & mapping. Responsible to Track stop trades & formulate strategy for activation. Achieve of monthly / quarterly & yearly targets of new client revenue & increase in AUM as defined by the organization Conducting synergy meetings between internal teams with a objective to meet set targets Check gaps and conduct quality training for the sales teams for time to time and report to Management Will be responsible to prepare relevant dashboards and give insights for quality improvement for end-to-end Quality assurance and auditing. Preferred candidate profile A. Graduation / MBA in any stream with 1- 5 years of sales/dealing/advisory experience in broking domain. B. Experience of Capital Markets is mandatory Interested candidate can mail sudhir.singh @sbicapsec.com . Sudhir Singh- HR SBI Capital Securities

Role & responsibilities 1. Inspection & sampling of Raw materials / Packaging materials / Finished Goods as per sampling plan. 2. Analysis of Raw material / Packaging material / Intermediates / Semi processed materials & Finished Goods in complete manner as per the current specification 3. Carrying out regular test i.e. or analeptic & physico - chemical analysis of WIP and F.G. 4. Filling up the analytical protocols in a clear and legible writing, entering all Data in the Software. Systematically storing all the records and documents. 5. Maintaining reserve samples of RM systematically up to additional three months after receipt date. 6. Conducting calibrations checks of all Lab instruments regularly on its due intervals. 7. Reporting non-conformance immediately to Executive-QC / Production for further necessary action. 8. Conducting stability analysis under the guidance of QC/QA Manager. 9. Maintaining documents and data as per the requirement of -14001, ISO-9001 and ISO-18001 10. Reserve control samples of RM and FG with proper labeling 11. To train and guide lab assistant in collection of spills, containing, cleaning and neutralizing of spilled and or expired lab chemicals/ reagents before being disposal. 12. Use of appropriate PPE while carrying out sampling of hazardous chemicals 13. Maintaining spill kits at handy to contain any accidental spillages and aware of disposal procedures. 14. Perform other tasks as requested or assigned. 15. Help to achieving objectives, completing EMPs and SMPs. 16. Provides assistance during audits & inspection 17. Implements QMS & EMS requirements relevant to the work area 18. Ensure continual improvement of QMS and EMS and comply with defined procedures. 19. Under direction of Site main Controller undertake duties as required by agreed emergency procedures. 20. In case of unit 1 and 3 he can look after the dispatch activity of Finished goods as per SOP with coordination with QA department and report any abnormality to QA Privi Behavioral Competencies Managing Business Business Acumen Change Management Managing Others Building Team Nurture Talent Managing Self Innovation and Creativity Drive Results Functional Competencies 1. Chemistry 2. All Systems related to QC lab knowledge 3. Trouble shooting 4. Communication skill

Roles and Responsibilities Conduct quality audits to identify areas of improvement in processes and procedures. Develop and implement quality management systems to ensure compliance with industry standards. Collaborate with cross-functional teams to resolve customer complaints and improve overall product quality. Analyze data from various sources (e.g., CAPA reports) to track trends and make recommendations for process improvements. Provide training on quality control procedures to employees at all levels within the organization. Desired Candidate Profile 12-15 years of experience 2 Years as Senior Manager Quality in Quality Management, Quality Audit, or related field. Excellent analytical skills with ability to interpret complex data sets and develop actionable insights. Effective communication skills with ability to present findings and recommendations to both technical and non-technical stakeholders.

Manager – Quality B.E/B.Tech (Metallurgy/Mechanical) 5–10 yrs experience Strong in ISO 9001, IATF 16949, APQP, PPAP, 8D, CAPA, MSA, SPC Knowledge of ASTM, EN, IS standards CTC: 10-15 LPA Required Candidate profile Send your resume via WhatsApp: 8013014471 Ideaspot Consultant / Kolkata

Hi, Greetings from ReSource Pro!!! Interested candidates can also share your CV to the below email. Hina_Taj@resourcepro.in Job Description - Client Specialist, SDU, India I. Basic Information Job Title: Client Specialist Report to: AM - Service Delivery Department: Service Delivery Unit Location: Bangalore, India II. Purpose of the Position Processes complex tasks, implements new tasks and/or manages existing tasks without supervision . Provides guidance, instruction and direction to the team of client associates and client analysts. Ensures to maintain and meet the quality and quantity standards, with timelines. Responsible for meeting quality, quantity, and timeliness requirements. III. Principal Responsibilities Responsibilities Responsibility Area (E.g. Budgeting & Planning, Team Management, etc.) Description (Do in order to/to ) 1.Operates a variety of client systems and performs complex tasks and activities without supervision following information security policies, procedures and guidelines. Meets and exceeds client performance standards. 2.Interacts with co-workers and supervisors to audit and troubleshoot to meet client needs in a timely manner. Takes initiative to find solutions and works effectively as a member of the team. 3.Develops and implements procedures to meet quality, quantity, and timeliness standards. 4.Composes clear, polite, and well-organized emails to communicate with clients. Anticipates client needs proactively and takes initiative. 5.Coaches less-experienced staff in learning procedures and insurance knowledge. 6.Analyzes the root cause of processing problems and keeps team and supervisor, and client informed of issues and solutions. The above responsibilities are not inclusive. Other responsibilities may be assigned to this job position depending on business needs IV. Minimum Qualifications Experience: 5+ years at least and 1.5+ years as a Team Lead or SME Education Background: Bachelor Degree (Major) Skills: Auditing, Training, Quality check, SOP creation, Process Transition, Escalation management, Performance management, Attrition and Shrinkage.

Job description: Preparing necessary documentations for the Rankings and Accreditation Providing necessary support to senior team members, studying other institutions through open sources. Creating robust documentation records and follow up Audits and ATR. Ensure timely reporting through SOPs and creating flow of documentation using Advance tools. In-depth understanding of accreditation frameworks (NAAC, NBA, NIRF, QS, etc.) and ability to prepare necessary documentation in alignment with the requirement of IQAC and Regulatory bodies (NAAC/NBA). Proficiency in analyzing feedback and institutional data using tools like Excel, Power BI, or Tableau. Ability to create interactive dashboards for evidence-based decision-making and stakeholder reporting. Strong interpersonal and technical skills, including proficiency in preparing spreadsheets and maintaining records of ongoing and past activities Must have prior experience as a key member of an institutional committee that has successfully gone through at least one cycle of NAAC accreditation. Possess comprehensive knowledge of national accreditations systems and basic understanding about Rankings, including NAAC, NBA, NIRF, and QS. Skilled in aligning institutional documentation with the requirements of Internal Quality Assurance Cells (IQAC) and regulatory bodies, ensuring compliance and excellence in quality benchmarks. Experienced in analyzing institutional feedback and performance metrics using tools such as Microsoft Excel, Power BI, and Tableau. Capable of transforming complex data sets into actionable insights to inform strategic decisions and drive continuous improvement. Adept at designing and implementing interactive dashboards that facilitate evidence-based decision-making and enhance transparency for stakeholders. Proficient in compiling comprehensive quality reports, including the Annual Quality Assurance Report (AQAR), Self-Study Report (SSR) and Self-Assessment Report (SAR), in accordance with NAAC/NBA guidelines, to support institutional reforms and promote continuous improvement. Education Background UG/PG in any discipline, Note For Intern Position (Optional Position) : Freshers or Less than 6 months of experience only are preferred with excellent communication, knowledge in MS Excel and Word Outstanding Interpersonal skills, Communication skills and Assessment, highly committed and enthusiastic. Perks and Benefits Perks and Benefits Added benefits like free A/C Bus transportation facility (Vijayawada, Guntur and Tenali) and 5-day work structure.

HCLTech Walk-in Drive for Quality Analyst & Quality Team Lead- 2nd &3rd of June 25 Timings: 11:00AM- 2:00PM Venue: 138, 602/3, Medavakkam High Road, Elcot Sez, Sholinganallur, Chennai, Tamil Nadu 600119. JOB SUMMARY This position is responsible for the daily quality review of transactions and calls from voice staff in support of healthcare operations, overseeing quality assurance and improvement. Additionally, the position entails identifying, recommending, and implementing quality improvement programs and practices aimed at enhancing process improvement, customer experience and ensuring high-performing operation. It will be an individual contributor. KEY WORDS Quality Analyst, Good Communication, Customer feedback response handling, Agent feedback and coaching, RCA, CAPA, Quality Tools, RCM, US Healthcare. ESSENTIAL RESPONSIBILITIES : Achieve daily QA targets Review and assess transactions, including calls Provide fair, concise, and objective feedback Report findings to agents and leads for training and improvement Collaborate on quality processes and scoring techniques Timely report quality monitoring for agents Raise and resolve QA concerns promptly Coach and provide feedback to monitored personnel and supervisors Identify quality improvement opportunities using business tools Calibrate scores objectively Ensure consistency across sites and teams focusing on customer experience and performance Analyze quality data to identify root causes and recommend improvements Prepare monthly and ad hoc QA reports timely Work with leads and training team to address areas for improvement from QA results. SKILLS AND COMPETENCIES Provides regular coaching and feedback to agents Motivates employees for better results Strong communication and listening skills Capable of coaching for performance improvement Knowledgeable about the US Healthcare industry Understands healthcare provider business policies and practices Advanced interpersonal, presentation, and communication skills Effective problem-solving, decision-making, and innovative thinking Proficient in Microsoft Office. FORMAL EDUCATION AND EXPERIENCE Graduation in any stream Experience in denial management and calling. 1-2 years of experience as full time quality analyst in US Healthcare

Must have contributed to Customer Audit (Maruti VSA System) Inspect incoming materials, raw components, and in-process products Monitor manufacturing processes, Data inspections, testing,trends, patterns,potential quality issues. Required Candidate profile knowledge of PPAP, MSA, SPC, CAPA, PFMEA mandate Investigate quality issues, identify root causes, and implement corrective and preventive actions to prevent future defect Collaborate with other dept

Role & responsibilities Lead a team of QA professionals to manage QA oversight to Manufacturing process operations. Provide leadership for lot release, incoming quality, manufacturing, and labs investigations, change control and corrective and preventative action review/approval, manufacturing support, record review/approval, and ongoing projects support etc. Support team by guidance and coaching and provide direction/approval of activities and decisions. Coordinate planned external audits and drive Internal Audit plan and share reports and outcome to the Site Management Team proposing continuous improvement action plan Analyze trends, quality metrics and other data to identify quality and compliance gaps. Manage release of product batches, including owning the QA product release workflow in SAP. Develop and maintain a Quality Management System in accordance with domestic and international regulatory requirements Manage Quality Control related activities regarding all in-process checks, deviations, RM release, and finished product release. Ensure that products conform to specifications and regulatory requirements. Approve or reject all formulations, procedures, specifications, test methods, raw materials, packaging materials, and finished products, including products manufactured at third parties , based on conformance / non-conformance to respective specifications that affect the purity, quality, and composition of each product. Oversee complaint handling, corrective and preventive actions, internal audit program, supplier quality assurance, product inspection and release, equipment calibration, and control of nonconforming material. Maintain Master formulations, Change Control, and history records. Develop & make a master formula for all new registrations. Identify and analyze issues related to in-process manufacturing and resolve them. Maintain and improve product quality by completing product and company system, compliance, and surveillance audits; investigating customer complaints; collaborating with other members of management to develop a new product, and manufacturing and training methods. Responsible for periodic review of SOP s, specification and standard operating procedure. Responsible for trouble shutting of analytical instruments. Responsible for Quality training initiative (GMP) across the site. Candidates must have experience HVAC validations . Candidates must have experience in microbiology sections . Candidates must have experience in handling of BMR, BPR,IPQA. Candidate worked regulatory environment like WHO-GMP, MHRA,EU-GMP etc. Candidates must have experience FDA license registration process Candidates must have experience in dossiers preparation.

Job Title: Quality Analyst International BPO Location: Gurugram, Haryana Salary: Up to 35,000 per month Experience Required: Minimum 2 years (International BPO process) Job Summary: We are seeking a highly motivated and detail-oriented Quality Analyst with a minimum of 2 years of experience in an International BPO environment. The ideal candidate will be responsible for monitoring and evaluating the quality of voice and non-voice interactions, identifying improvement areas, and supporting agents with constructive feedback and training insights. Key Responsibilities: Monitor and evaluate customer interactions across voice channel Conduct quality audits and provide actionable insights to enhance performance Identify process gaps and suggest improvements Maintain and update QA scorecards and performance dashboards Provide regular feedback and coaching to agents for performance improvement Collaborate with Training and Operations teams to develop and implement quality improvement plans Prepare and share weekly/monthly quality reports with stakeholders Ensure adherence to client and organizational quality standards Qualifications & Skills: Minimum 2 years of QA experience in an International BPO (voice) Strong understanding of quality monitoring tools and KPIs Excellent communication and analytical skills Ability to work in a fast-paced environment and handle multiple tasks Experience with CRM tools and QA platforms (preferred) Work Environment & Benefits: Competitive salary up to 35,000 per month Opportunity to work with global clients Supportive and inclusive team environment Career growth and skill development opportunities 6-day fixed working schedule How to Apply: Interested candidates may send their updated resume to [hr@galacticcs.com or Abhinavhr@galacticcs.com]

Lead quality initiatives & drive continuous improvement Develop & implement quality strategies Conduct regular audits & inspections. Ensure compliance with industry standard Ensure that products meet quality standards and customer expectations.

Role & responsibilities Execute Quality control and Quality Assurance best practices across all the plants in SBU. Create and implement best practice quality vision, strategy, policies, processes and procedures to aid and improve business performance Establish quality and reliability standards by studying industry benchmarks and the requirements of customers and research/design and development, and define the metrics required to assess performance against standards required Conduct periodic reviews of Quality initiatives and formulate action points for respective plants. Identify projects for quality, real-time manufacturing improvements, cost reduction & safer workplace Ensure effective internal and external audits are conducted for Quality systems, processes, and procedures across plants Build quality awareness across the SBU by using different interventions like training, slogan/poster campaign etc Ensure that corrective actions are delivered and non-compliance issues are resolved on time Enforce compliance with internal procedures to ensure that established quality and process procedures are being followed by the appropriate personnel at all times Incubate and bring in new methodologies for process improvements and deploy corresponding analytical tools to measure the effectiveness of the same Drive total quality management including developing skills and competencies of the employees. Ensure that project/department milestones/goals are met and adhering to approved budgets Develop and maintain strong relationships with internal and external stakeholders to ensure optimal performance Work collaboratively, negotiate and engage with key stakeholders to facilitate delivery and compliance with the quality strategy Implementation of administration and measurement of total quality management programs Six Sigma initiatives, Lean Manufacturing etc. Drive organizational initiatives like safety, health etc. in the team. Preferred candidate profile Knowledge of Total Quality Management Practices LEAN, Six Sigma and other best process Knowledge and technical understanding of automotive processes, components and manufacturing techniques Knowledge of Quality systems , ISO and quality assurance policies. Desired Qualification & Experience: B.Tech (Mech.) with Six Sigma/Lean certification 3-10 Years of Experience in heavy engineering industry

Reinforcement checking as per B.B.S & drawing Monthly Concrete reconciliation Checking the quality of concrete at pumping station before pumping. DP Test , Formwork checking, Maintain of all document as per QAP CTC upto 5LPA Whatsapp on 9820831597 Required Candidate profile B.E./ B.Tech in Civil Must have 3+ years Exp in High Rise Building Prefer candidate working in civil contracting firm

Support Ops currently caters to Fulfillment by Amazon (FBA) for NA marketplace. FBA is built around Amazon s world class capability in ordering, fulfillment, transportation and Customer service. By leveraging our current scale and supply chain, FBA provides a low cost alternative for fulfillment and enables third party Sellers to rapidly grow their business. The FBA Support Ops team is a critical operational group that reviews Sellers financial and inventory related questions, provides coaching to Sellers on defects, and manages Jeff B and VP level executive escalations. We believe consistency is the foundation to the world class service we provide our Sellers, and Support Operations is at the center of ensuring consistent and fair evaluation of Seller requests. Support Ops has a head start of 7 years into managing FBA operations, equipped with dedicated support teams like AA (Associate Advisors), QA (Quality Audit), LD (Learning and Development), CP (Capacity Planning), Analytics Tech. In 2019, the team launched its operations in Hyderabad, India and further expanded its global presence to China in 2020. This role requires a leader to manage the front line managers, and their respective teams. If you are passionate about people, process and stakeholder management and are excited to take on new business challenges, this is the right role for you. The Support Ops Manager II, India is responsible for safety, budgetary, people development and operations objectives for the FBA Support Operations teams in their remit across physical sites in India. Responsibilities include directly managing and leading a team of Front-line Operations Manager with an extended organization of approximately 100 people, ensuring performance objectives are met or exceeded, building positive employee relations, developing leadership bench strength, collaborating effectively with cross-functional stakeholders, planning strategically and raising the bar on seller experience through effective FBA support delivery. The role requires strong understanding of FBA Support operations, seller support ecosystem, and demonstrated ability to drive operational excellence in a multicultural support environment. Operations: The candidate needs to be able to drive results in a production environment. Must lead their team and stakeholders towards meeting operational metrics of quality, productivity, and service levels. Will be responsible for setting the goals and vision for the function(s) operating under the candidate. Stakeholder Management and Communication: The candidate would need to interact with multiple stakeholders within India and globally and at times, would be required to influence and drive consensus between teams. The candidate would also be required to write high impact, clear and concise documents (Support Strategies, Business review documents, etc.). People Leadership: The candidate would be responsible for creating mechanisms for employee growth and development. This would mean enabling People Managers and creating succession plans. Will strike the right balance between effective delegation while maintain a connect with the team through different communication channels (1:1 connects, Huddles, Open office hours etc.). Process Improvements, Automation, and Innovation: The candidate would need to drive innovation within the team, such that operational inefficiencies can be removed and existing procedures/SOPs be enhanced. Should be able to identify and lead projects across various teams, develop new metrics and drive creation of new tools for the same. We value individual expression, respect different opinions, and work together to create a culture where each of us is able to contribute fully. Our unique backgrounds and perspectives strengthen our ability to achieve Amazon s mission of being Earth s most customer-centric company. - 3+ years of team management experience - 8+ years of operational and/or retail management experience - Experience using data to influence business decisions - Experience across the domain of risk management compliance operations - 2+ Years of experience as Manager of Managers - Knowledge of Microsoft Office products and applications (esp. MS Excel, Word) at an advanced level - Experience in operational excellence using six sigma methodologies

Experience: 6 months as QA (IPDRG) on papers Certification - Mandatory Salary: Best in industry Immediate joiners - preferred Location: Chennai & Hyderabad Interested candidates reach out to: Reneth HR -7904010785 / Deepikaa HR -7904574485 Required Candidate profile Candidate should have a minimum of 6 months of experience as a QA for IPDRG (on papers) Any Certification - Can apply Notice period : up to 30 days is acceptable

Develop & implement quality control procedures & inspection protocols. Familiarity with quality standards such as ISO 9001,Six Sigma. Knowledge of QA/QC tools(FMEA/SPC/8D/CAPA) Experience in measurement & testing equipment--calipers/micrometers/CMMs Required Candidate profile Certification in CQE(Certified Quality Engineer) or Six Sigma Green/Black Belt. Experience in [industry-specific tools or systems, e.g., automotive, electronics, etc.] & Lean Manufacturing principles. Perks and benefits SALARY:18000/-To 30000/- AS PER SKILL & EXPERIENCE

Handle customer queries with respect to process,FSMS & QMS - implementing them in application center as per documentation.Handle customer complaints, internal audits & MRM.Regulatory communications.Annual calibration activities at application centre. Required Candidate profile M.Tech/Masters / B. Tech in food science/food processing

Quality Manager/ Lead/Incharge Job Description Role and Responsibilities: Monitoring and driving quality management and audit activities for logistics services. Monitor the effective closure of the audit findings. Monitoring the database of problem sheets and coordinating with customer for effective closure. Monitoring the timely communication of receiving suspected damage cases to customer representatives. Monitoring the material rejection at customer rejection room meeting and provide subsequent analysis. Make optimum utilization of Lean Manufacturing methods to assist in preparing the feasibility studies for the operations. Develop methods that would help in reducing the cost without compromising on the quality standards to ensure increased efficiency. SOP Documentation and implementation of every procedure inside plant and warehouse. Establish and conduct process reviews as per defined frequency. Monitoring of the adherence of daily 5S Audit schedule and subsequent result review. Responsible to drive and implement best 5S practices within the scope of operations. Mentor continuous Improvement projects like Kaizen, QC projects, Six Sigma, etc. and maintain the track of project status. Ensure everyone in your team follows the Standard Operating Procedure (SOP) and Work Instruction (WI) Achieve audit targets in 5S,QMS, ISO, EMS, EnMS, OHSMS,VDA 6.3, etc. Monitor adherence of safety standards in your area/department. Report departmental KPIs, any deviation, reasons for gaps and countermeasures. Manage the information flow and coordinate among respective departments within company and customer. Mentor and give required training to the team members. Knowledge & adherence of QMS practices. Monitoring, analyse & review of all KPIs related to Scope of Operation. Ensuring CA&PA Submission & checked its sustenance Authority: Sign and approve leave for subordinates below 7 days at a stretch. Authorized to sign in the QMS documents. Take decisions on suspected external damages of the boxes. Management representative for the organization of various certifications like ISO, QMS, EMS, EnMS, OHSMS, VDA 6.3, 5S, etc. Sign and approve leave of subordinates below 7 days at a stretch. Drafting and control of distribution of all process documents. Coordinator for 5S audits conducted by customer and third party. Role & responsibilities Preferred candidate profile

Responsibilities: * Conduct quality audits, inspections & CAPAs * Ensure compliance with IAFT16949 standards * Collaborate on Lean Six Sigma projects * Implement VDA6.3 methodology * Drive continuous improvement initiatives Annual bonus Health insurance

Job Profile: Associate Operations Roles and Responsibilities Manage daily operations of the clinic, ensuring smooth functioning and high-quality patient care. Conduct quality audits to identify areas for improvement and implement corrective actions. Oversee inventory management, including ordering supplies and managing stock levels. Collaborate with team members to achieve operational efficiency and effective communication among departments. Ensure compliance with hospital policies, procedures, and regulatory requirements. Desired Candidate Profile 1-4 years of experience in BDS or MBA/PGDM (Hospitality Management) preferred Strong analytical skills with ability to analyze data and make informed decisions. Excellent communication skills with ability to work effectively Ability to coordinate multiple tasks simultaneously while maintaining attention to detail. Experience: 02 Years Employment Type: Full Time Shift: 8:30 AM – 5:30 PM Salary: 25,000 – 35,000 per month

Any Graduate or DE / BE (Electrical/Mechanical) 5 - 7 Years Expertise in ISO standards,quality management systems,auditing procedures, documentation control,process improvement methodologies,leadership abilities, & effective communication skills.

Well known Denmark based pharma co Hiring QA Pharmacist Excellent communication skills 5 days working Pl share updated CV to careers5.righthire@gmail.com

What you will do Let’s do this. Let’s change the world. In this vital role you will own and implements the end-to-end global complaint process and management system, ensuring appropriate business connection across Amgen. In doing so, the focus is on assuring complaint processes and systems remain fully compliant through the quality operating standards and procedures to current, emerging internal and external requirements. In addition, the team translates information from the market to drive continuous improvement. The Senior Associate conducts low to medium complexity complaint investigations and determines if complaint investigations require issue for further investigation. Evaluates and ensures triaged product complaint records align with applicable procedures Evaluates and owns complaint records with basic investigations Ensures quality of complaint records Completes assigned assessments per applicable procedures Applies analytical skills to evaluate sophisticated situations using multiple sources of information Implements the complaint process per SOP requirements Owns or manages the review/approval process flow in CDOCS of controlled documents; while adhering to format, content, and style guidelines, considering usability, and ensuring accuracy, consistency, and quality according to templates and style guide Supports management of assigned projects or project tasks to achieve agreed results within time and with encouraged quality, including (but not limited to) proactive written / in person communication, status updates, tracker & tool maintenance What we expect of you We are all different, yet we all use our unique contributions to serve patients. Basic Qualifications: Master’s degree and 1 to 3 years of Quality experience OR Bachelor’s degree and 3 to 5 years of Quality experience OR Diploma and 7 to 9 years of Quality experience Preferred Qualifications: Quality and/or manufacturing experience in biotech, medical device or pharmaceutical industry Bachelor’s Degree in a Science Field Ability to successfully manage workload to timelines Familiarity with basic project management tools Ability to operate in a matrixed or team environment with site, functional, and senior management leadership Experience in driving decision making by using the DAI principles Understanding of quality and industry requirements/expectations of a QMS Understanding of the applicable manufacturing/testing processes (i.e., API, Drug Substance, Drug Product, Packaging, Device manufacturing processes) Ability to negotiate a position after taking feedback from multiple sources Demonstrated ability to lead functional teams, consistently deliver timely, and high-quality results Ability to translate business and key collaborator feedback and requirements into accurate and efficient processes using clear language and format What you can expect of us As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we’ll support your journey every step of the way. In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards. Apply now for a career that defies imagination Objects in your future are closer than they appear. Join us. careers.amgen.com As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease. Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

What you will do Let’s do this. Let’s change the world. In this vital role you will conduct complex complaint investigations, resolves corrective actions with their effectiveness and resolves steps necessary to ensure the proper level of control for product in distribution. We are seeking a Specialist Quality Complaints Complaint Owner and member of the Product Complaints and Surveillance team. The Product Complaints and Surveillance team owns and implements the end-to-end global complaint process and management system, ensuring appropriate business connection across Amgen. In doing so, the focus is on assuring complaint processes and systems remain fully compliant through the quality operating standards and procedures to current, emerging internal and external requirements. In addition, the team translates information from the market to drive continuous improvement. Ensures quality of complaint records Applies analytical abilities to evaluate complex situations using multiple sources of information Execution of regulatory and SOP requirements Anticipates and prevents potential issues with regulators Provides guidance and technical advice Evaluates subject matter expert assessments Raises potential Quality issues to Management What we expect of you We are all different, yet we all use our unique contributions to serve patients. Basic Qualifications: Doctorate degree OR , Master’s degree and 4 to 6 years of Specialist Quality Complaints experience OR , Bachelor’s degree and 6 to 8 years of Specialist Quality Complaints experience OR , Diploma and 10 to 12 years of Specialist Quality Complaints experience Preferred Qualifications: Quality and manufacturing experience in biotech or pharmaceutical industry Ability to oversee multiple projects simultaneously Ability to successfully handle workload to timelines Familiarity with basic project management tools Ability to negotiate a position after taking feedback from multiple sources Demonstrated ability to consistently deliver on-time, and high-quality results Ability to operate in a matrixed or team environment Understanding of the applicable manufacturing/testing processes (i.e. API, Drug Substance, Drug Product, Packaging, Device manufacturing processes) What you can expect of us As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we’ll support your journey every step of the way. In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards. Apply now for a career that defies imagination Objects in your future are closer than they appear. Join us. careers.amgen.com As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease. Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.