Supervisor, Quality Assurance (Swing Shift)

Physical Demands & Work Conditions

• Production Associates: Must have visual acuity of 20/20 (corrected or uncorrected) and normal color vision to safely perform critical tasks such as visual inspection of materials, equipment, and labeling, including distinguishing color-coded components in a GMP environment.
• Must meet cleanroom gowning requirements, including wearing full gowning (face coverings, gloves, hoods, goggles) for up to 3 consecutive hours at a time, minimal movement in the cleanroom, and working with or around human blood, blood-derived materials, cells, other biological materials, and alcohol-based sprays. Use of cosmetics (makeup, painted nails), jewelry, or facial piercings is not permitted in the cleanroom, and any skin conditions that cause shedding must be disclosed.
• Must be comfortable regularly participating in video-based meetings.

Key Responsibilities

Leadership and Team Management:

• Supervise, mentor, and develop a team of QA technicians assigned to manufacturing and QC operations.
• Schedule and prioritize daily QA activities to ensure timely support for production and lab functions.
• Provide ongoing training, performance evaluations, and career development support for team members.
• Serve as QA representative in cross-functional meetings related to operations and quality systems, promoting a culture of compliance and continuous improvement.
• Provide technical guidance and mentorship to ensure high quality and compliant practices.

Operational Support:

• Oversee on-the-floor QA support for manufacturing and QC activities including batch record review, in-process checks, line clearance, and deviation response.
• Ensure timely review and approval of manufacturing and QC documentation (e.g., batch records, logbooks, equipment use records, test data).
• Support real-time issue resolution during production and testing activities, escalating concerns as needed.
• Monitor compliance with Good Manufacturing Practices (cGMP), Good Documentation Practices (GDP), and internal SOPs.
• Assist in the preparation and review of master batch records, standard operating procedures (SOPs), and other relevant documentation.

Quality Systems & Compliance:

• Supervisors are expected to supervise Quality System performance for themselves and their team.
• Ensure effective implementation and adherence to quality systems including deviation management, CAPAs, change control, and investigations.
• Review and approve deviations, investigations, and change controls related to manufacturing and QC.
• Participate in internal audits, regulatory inspections, and third-party audits as required.
• Support trending of quality data and contribute to continuous improvement initiatives.
• Collaborate with cross-functional teams (QC, Manufacturing, MSAT, etc.) to drive resolution of quality and technical issues.

Record Management Readiness:

• Monitor record management conditions and practices to ensure consistent compliance with cGMP and FDA/EMA regulations.
• Manage documentation, equipment logs, and records to support readiness for internal and external inspections.
• Lead preparation activities for audits and regulatory inspections, including document reviews and mock audits.

Continuous Improvement, Collaboration, and Communication:

• Identify opportunities to enhance operations, workflow efficiency, and compliance practices.
• Participate in the revision and development of SOPs and policies.
• Liaise with Manufacturing, QC, Validation, Engineering, and other departments to ensure QA oversight and alignment.
• Communicate quality expectations, regulatory changes, and quality system updates to the team and relevant stakeholders.
• Support implementation of new procedures, processes, and equipment from a QA perspective.
• Perform other duties as requested by supervisor/manager to support Quality.
• Stay current with industry regulations, standards, and best practices related to quality assurance.
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Minimum Qualifications

• Bachelor’s degree in Life Sciences, Chemistry, Biology, or a related scientific discipline
• Minimum of 5 years of experience in Quality Assurance within a regulated pharmaceutical, biotechnology, or medical device environment.
• Minimum of 1-2 years in a leadership or supervisory role is preferred.
• Strong knowledge of cGMP, FDA, and ICH guidelines.
• Strong analytical, problem-solving, and decision-making skills.
• Excellent written and verbal communication.
• Detail-oriented with strong organizational skills.
• Ability to manage multiple priorities and work in a fast-paced environment.