QA Technical Specialist

Key Responsibilities -

Management Review

• Coordinate and manage all logistics related to Site Management Review, including compiling metrics, maintaining and updating Smartsheet trackers, and preparing content.
• Perform site-level and cross-site trend analysis (as applicable) using key quality metrics; identify trends and collaborate with site stakeholders to implement corrective and preventive actions (CAPA).
• Lead preparation of Management Review meetings, ensuring comprehensive data presentation creation, documentation of meeting minutes, and follow-up on action items.

Inspections and Compliance

• Support readiness and response for internal and external inspections, including generation of pre-inspection documents such as deviation lists, change controls, and supporting evidence.
• Actively contribute during inspections by managing information requests, facilitating document electronic retrieval, and preparing responses in collaboration with subject matter experts.
• Lead Site Master File updates by coordinating content input from cross-functional stakeholders, drafting revisions, and managing review and approval workflows.

Technical Writing and Data Analytics

• Lead authoring and workflow coordination for periodic quality trend reports and related documentation.
• Generate deviation summary reports to support product and process monitoring efforts, ensuring accuracy and consistency with cGMP standards.
• Drive quality risk assessments, providing technical leadership in risk identification, analysis, and mitigation planning in alignment with standards.

Preferred Qualifications

• Demonstrated experience in a GMP-compliant environment with working knowledge of inspection protocols, site audits, and quality risk management principles.
• Proficiency in technical writing and data visualization tools; experience with Smartsheet, Tableau, or equivalent platforms preferred.
• Strong analytical skills with the ability to interpret data trends and drive improvements based on quality insights.
• Familiarity with electronic quality systems (e. g. , Veeva, TrackWise, SAP-QM, LIMS) and documentation practices.
• Excellent verbal and written communication skills, including experience presenting to senior leaders.
• Proven ability to lead and collaborate within cross-functional teams in a dynamic, fast-paced setting.

Core Competencies

• Leadership in Quality Governance (e. g. , Management Review)
• Inspection Readiness and Compliance Assurance
• Quality Data Visualization, Interpretation and Analytics
• Technical Document Drafting and Workflow Ownership
• Cross-Functional Stakeholder Engagement
• Continuous Improvement Mindset

Basic Qualifications and Experience:

• Master s degree with 5-9 years of Pharma and Biotech commercial or clinical manufacturing Quality experience.