Job
Description
Position Summary: Ensure the client receives quality data in a timely manner by reviewing laboratory documentation, generated data, calculated results, and final reports for accuracy, clarity, and adherence to GMP and/or GLP regulations, and evaluating problems/system failures to achieve efficiency gains Essential Duties and Responsibilities: Applies GMP/GLP in all areas of responsibility, as appropriate Demonstrate and promote the company vision Regular attendance and punctuality Processing of simple and complex routine and non-routine data (for 3 or more areas) according to departmental, corporate, and client SOPs; read and understand analytical procedures; make sure all work is performed according to GLP/GMP requirements; perform complex calculations Communication in writing and in person with laboratory personnel in an intelligent and clear manner Exercise discretion and independent judgment with respect to matters of significance directly related to the management or general business operations through the data review process Perform review of scientific data, including, but not limited to standard preparation, calibrations, methodology, QC, sample data, integration review, compound evaluation, chemical identification, and other subjective review based on testing performed; perform complex calculations to verify results Verify the data is of sound quality and determine if data is compliant and defendable based on industry regulations and methodology May serve as technical advisor for analysts with regard to QA/QC of data Diagnose problems; solve simple problems, and suggest solution to complete problems in professional area Keep oneself and peers abreast of current developments and trends in professional area by reading and understanding internal procedures, attending/providing training sessions, by writing/revising SOPs (as required), and by assisting Group Leader / Principal Specialists in training new and existing employees Attention to details Use MS Windows applications such as Excel, Word, Access, Outlook email; create complex Excel worksheets and formulas Communicate with internal clients to discuss any findings and notify them of any necessary rework or compliance/regulatory concerns Conducts all activities in a safe and efficient manner Performs other duties as assigned Qualifications Education/Experience (BMQ): Masters degree in a pharma / science-related field with at least 8-10 years of experience or Ph. D degree (preferred) with 5 years in Bio/Pharmaceutical Analysis experience with knowledge of regulatory requirements and data review responsibilities Experience with chromatography and mass spectrometry analytical techniques (HPLC, GC, LC/MS, GC/MS) Experience identifying unknown compounds by mass spectrometry (ideally by LC/MS-TOF and/or LC/MS-QTOF) Additional Preferences: Experience with Agilent MassHunter software Experience with extractables and leachables testing Knowledge of USP/EP compendia, and laboratory software applications such as Waters Empower software, LIMS, Electronic Notebook is preferred Key Candidate Attributes: Self-motivation; excellent quality of work and attention to detail Ability to communicate effectively with coworkers and internal/external clients Ability to learn new tasks quickly and to move easily from task to task Ability to handle prioritization and multiple tasks simultaneously Ability to use a personal computer and learn necessary programs Good communication skills (oral and written) Organizational ability and good judgement Science background/education and/or laboratory experience Strong Math Skills Logical Thinking, Good Reasoning Ability Motivation to excel Coaching/mentoring of peers
