Product Quality Assurance Supervisor

August Bioservices; Nashville (TN); On-site; USD 90,000 - 120,000; Full time

Job summary

August Bioservices seeks a Product Quality Assurance Supervisor to lead AQL and QAOTF programs, overseeing QA Specialists across production shifts and ensuring real-time GMP compliance. You will supervise QA activities, ensure batch records/SOPs adherence, and escalate quality concerns as needed.

Responsibilities include staffing, coaching, investigations, CAPAs, deviations, and batch disposition support, with collaboration across Manufacturing and Quality Management to maintain a

Qualifications

• Master’s degree with 2+ years QA/DEA in biotech/pharma.
• Bachelor’s degree with 3+ years QA/DEA in biotech/pharma.

Responsibilities

• Directly supervise the AQL and QAOTF teams across shifts.
• Coach, mentor, and develop QA staff and performance.
• Manage staffing, scheduling, and shift coverage for manufacturing.
• Ensure GMP compliance and adherence to batch records and SOPs.
• Lead investigations, deviations, CAPAs, and change controls.
• Track metrics and drive QA process improvements.

Skills

GMP compliance

Root Cause Analysis

Risk Management

Technical Writing

Microsoft Office

eQMS & LIMS

Visual Inspection

CAPA & deviations

Communication

Leadership

Organizational Skills

Education

Master’s Degree (QA/DEA field)

Bachelor’s Degree (QA/DEA field)

Job description

The Product Quality Assurance Supervisor is responsible for the daily leadership and execution of the Acceptable Quality Level (AQL) and Quality on the Floor (QAOTF) programs. This position provides direct supervision of QA Specialists supporting manufacturing operations, ensuring continuous quality oversight of production activities, visual inspection programs, and real-time GMP compliance.

The Supervisor serves as the primary Quality representative supporting manufacturing operations across all production shifts while driving consistent execution of QAOTF activities.

ESSENTIAL DUTIES & RESPONSIBILITIES

• Directly supervise the AQL and Quality on the Floor teams.
• Provide coaching, mentoring, performance management, and employee development.
• Manage staffing, scheduling, workload balancing, and shift coverage to support manufacturing operations, including evenings and weekends.
• Conduct performance evaluations and establish development plans.
• Ensure effective QA presence during manufacturing operations.
• Provide real-time GMP oversight of production activities.
• Ensure manufacturing follows approved batch records, SOPs, and GMP requirements.
• Escalate quality concerns to QA Management as appropriate.
• Manage the Quality Assurance AQL and visual inspection program.
• Ensure inspection activities are performed in accordance with approved procedures.
• Maintain AQL visual inspection qualification programs.
• Partner with Manufacturing to establish inspection standards and qualification requirements.
• Monitor inspection trends and recommend process improvements.
• Partner with Manufacturing leadership to coordinate QAOTF support.
• Ensure appropriate QA coverage for production schedules.
• Support and review investigations, deviations, CAPAs, and change controls impacting manufacturing operations.
• Support batch record review and batch disposition/release activities.
• Participate in production meetings and provide Quality input.
• Ensure compliance with FDA, EMA, ICH, and company procedures.
• Identify compliance risks and implement corrective actions.
• Assist with internal audits, client audits, and regulatory inspections.
• Track and report department metrics including inspection effectiveness, QA observations, and compliance trends.
• Recommend improvements to QAOTF processes and inspection programs.
• Communicate quality issues promptly to the Product QA Manager.
• Build collaborative relationships across Manufacturing, QC, Validation, Engineering, and Supply Chain.
• Promote a quality-focused culture throughout manufacturing operations.

KNOWLEDGE, SKILLS, & ABILITIES

• GMP compliance knowledge including knowledge of 21CFR210, 211, 820 and the PICS Guide to Good Manufacturing Practices Part 1 and 2 or the EU Guidelines to Good Manufacturing Practice Medicinal Products for Human and Veterinary Use, including Annex 1 and FDA Guidance on Aseptic Processing and Part 11 compliance knowledge preferred.
• Root Cause Analysis Tools, Risk Management, Technical Writing, Microsoft Office applications, eQMS and LIMS systems.
• Experience with visual inspection, AQL programs, deviations, CAPAs, and manufacturing support activities.
• Strong communication, leadership, and organizational skills.

QUALIFICATIONS

Master’s Degree and 2+ years’ experience in Quality Assurance or a DEA related field within a biotechnology, biologics, or pharmaceutical manufacturing facility OR Bachelor’s Degree and 3+ years’ experience in Quality Assurance or a DEA related field within a biotechnology, biologics, or pharmaceutical manufacturing facility.

August Bioservices is an equal opportunity employer and values diversity. All aspects of employment including the decision to hire, promote, discipline, or discharge, will be based on merit, competence, performance, and business needs. August Bioservices does not discriminate on the basis of any status protected under federal, state, or local law.