Quality Assurance Supervisor - Second Shift

The QA Supervisor will partner closely with Production and Quality Assurance Management to identify and resolve manufacturing issues, facilitate timely deviation management and escalation, and maintain quality and compliance throughout aseptic operations.

Work Schedule & Environment

• Shift: 2nd Shift, Monday–Friday, 2:00 p.m.–10:30 p.m.
• This position requires regular onsite attendance at our Brentwood facility and cannot be performed remotely.
• Must be able to manage multiple responsibilities and competing priorities, including frequent email and phone communications, meetings, and conference calls that may extend beyond core working hours.
• Must be able to work effectively under strict production, time, and performance deadlines.
• Must be willing and able to work beyond regularly scheduled hours, including weekends and holidays, when necessary.

Role Responsibilities

Quality Leadership and Team Coordination

• Supervise, plan, and coordinate the daily activities of Quality Assurance colleagues, providing leadership and guidance to Quality Inspectors.
• Ensure adequate QA coverage throughout the shift, including Aseptic Processing Areas (APA) and Grade D/Controlled Not Classified (CNC) areas.
• Coordinate shift personnel activities, including training, vacation schedules, and absences, to maintain appropriate Quality Assurance coverage.
• Ensure required training and qualification curricula are completed and maintained for direct reports.
• Address employee-related issues as appropriate and in accordance with company policies.
• Generate clear, concise daily written shift reports for Quality and Production Management.
• Attend and participate in daily shift huddles and Gemba meetings.

Aseptic Manufacturing and Quality Oversight

• Ensure quality inspections and batch record reviews are performed in accordance with established standards, Standard Operating Procedures (SOPs), GMP, GDP, and applicable regulatory requirements.
• Review batch records for conformance to established procedures and critical process parameters.
• Demonstrate proficiency in internal manufacturing and quality assurance procedures and applicable compliance requirements.
• Successfully complete and maintain sterile gowning qualifications to support critical aseptic processing areas.
• Participate in media fills as a Quality Observer when needed.
• Train on performing line clearance and verification of critical manufacturing areas.
• Perform daily online audits in aseptic processing areas to maintain an audit-ready environment.

Deviation Management and Continuous Improvement

• Partner with Production and Quality Assurance Management to identify and resolve manufacturing and quality issues, escalating critical concerns appropriately.
• Initiate incidents in the Quality Tracking System (QTS), as applicable.
• Support manufacturing investigations through root cause analysis and identification of corrective and preventive actions.
• Identify opportunities to improve Standard Operating Procedures (SOPs) and Master Batch Records.
• Coordinate and support changes to SOPs, specifications, and batch records as applicable.
• Support quality event documentation and change management activities.
• Review quality data for consistency with established policies and procedures and contribute to problem-solving and continuous improvement initiatives.

Basic Qualifications

Education – Required

• Bachelor's or associate's degree in a technical or science-related discipline, with relevant experience and/or training, or an equivalent combination of education and experience.

Experience – Required

• Minimum of two years of aseptic manufacturing experience.
• Minimum of one year of supervisory or demonstrated team leadership experience in a relevant manufacturing environment.
• Experience working in pharmaceutical manufacturing or a comparable regulated manufacturing environment.
• Working knowledge of aseptic processing principles, Good Manufacturing Practices (GMP), Good Documentation Practices (GDP), and applicable regulatory requirements.
• Ability to produce quality work with minimal guidance.
• Ability to work effectively in a team environment and collaborate across departments.
• Ability to identify and resolve quality issues, recommend solutions, and escalate concerns appropriately.

Preferred Qualifications

• Supervisory experience in a pharmaceutical, combination product, or medical device manufacturing environment.
• Experience with TrackWise and inventory management systems such as SAP or PRISM. Experience with comparable electronic quality management systems or other relevant electronic systems may be considered in lieu of direct TrackWise experience.

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