Quality Assurance Supervisor at Confidential in Middlesex County, NJ

Position Summary

The Quality Assurance Supervisor is a hands-on working supervisor responsible for daily QA coverage across manufacturing operations and the site quality system. This role assigns and verifies work, maintains visible QA support on the manufacturing floor, and personally completes quality-system work when needed. The position coordinates document control, training, batch record review, investigations, CAPA, change control, supplier quality, audit readiness, and material or product disposition activities under the direction of the Head of Quality.

Essential Responsibilities

· Plan, assign, track, and verify the daily work of QA personnel; set priorities based on manufacturing schedules, investigation due dates, document needs, and audit commitments.

· Maintain active, responsive communication with Manufacturing, QC, Facilities, Engineering, Project Management, and clients; promptly acknowledge requests, communicate decisions, and escalate risks or delays.

· Provide routine floor QA coverage for GMP manufacturing, including line clearance, room and equipment status, documentation practices, material control, environmental monitoring coordination, and real-time resolution of compliance concerns.

· Review executed batch records, logbooks, laboratory or manufacturing support records, and release packages for accuracy, completeness, traceability, and compliance before disposition or release decisions.

· Lead or support deviations, quality investigations, OOS/OOT assessments, CAPAs, change controls, complaints, and effectiveness checks; ensure investigations identify supportable root causes and actions are completed on time.

· Administer the electronic and paper quality systems, including workflow assignment, record tracking, periodic review, reporting, and follow-up of overdue actions.

· Oversee document control, including document formatting, review and approval routing, effective-date control, issuance, reconciliation, archival, retention, retrieval, and maintenance of current indexes and controlled copies.

· Own the site training program, including curricula, assignment of training, qualification records, overdue follow-up, training-effectiveness checks, and periodic review of personnel training files.

· Support material, component, and product disposition activities by confirming that specifications, testing, deviations, and required documentation are complete and acceptable.

· Coordinate supplier and contract laboratory qualification, quality agreements, questionnaires, audits, performance monitoring, and maintenance of the approved vendor list.

· Plan and conduct internal audits and walkthroughs; host client and regulatory inspections; coordinate document requests, responses, commitments, and inspection-readiness activities.

· Develop and report meaningful quality metrics, trends, and priorities to the Head of Quality and Quality Council.

· Coach the QA Specialist, cross-train the team, provide timely performance feedback, and ensure critical duties have trained backup coverage.

· Draft, revise, review, and approve SOPs, forms, specifications, master batch records, protocols, reports, and other GMP documents within delegated authority.

· Perform other quality duties assigned by the Head of Quality and remain available for occasional off-shift or weekend manufacturing support.

Decision-Making and Escalation

· May stop or place work on hold when a condition could affect product quality, data integrity, patient safety, or GMP compliance.

· Escalates potential critical or major quality events, recurring deficiencies, missed commitments, and unresolved cross-functional issues to the Head of Quality without delay.

· Makes disposition, approval, and release decisions only within documented training, procedures, and delegated authority.

Required Qualifications

· Bachelor’s degree in a scientific, engineering, pharmacy, or related discipline; equivalent directly relevant experience may be considered.

· At least seven years of progressive pharmaceutical, biotechnology, or CDMO quality assurance experience, including direct support of GMP manufacturing.

· At least two years of experience leading people, projects, or daily QA workflow.

· Working knowledge of 21 CFR Parts 210 and 211, data integrity, good documentation practices, and applicable ICH guidance.

· Demonstrated experience with batch record review, investigations, CAPA, change control, document control, training, audits, and electronic quality management systems.

· Clear, timely written and verbal communication and the ability to work visibly and collaboratively across departments.

· Ability to manage competing priorities, meet deadlines, and personally complete detailed work in a small, hands-on QA department.

Preferred Qualifications

· Experience supporting aseptic processing, sterile manufacturing, media fills, environmental monitoring, or clinical manufacturing.

· Experience with supplier quality, validation, data review, client audits, regulatory inspections, and phase-appropriate product development.

· Experience administering Dot Compliance or another electronic QMS.

Success Measures

· Reliable daily QA coverage and timely responses to internal and client needs.

· On-time closure of investigations, CAPAs, change controls, training, and document actions.

· Accurate, complete, and inspection-ready records with effective backup coverage.

· Visible leadership, consistent follow-through, and constructive working relationships across the site.

Pay: $110,000.00 - $130,000.00 per year

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Flexible spending account
• Health insurance
• Life insurance
• Paid time off
• Vision insurance

Work Location: In person