Product Quality Assurance Supervisor

Augustbio; Nashville (TN); On-site; USD 85,000 - 120,000; Full time

Job summary

August Bioservices seeks a Product Quality Assurance Supervisor to lead AQL and QAOTF programs on the floor, ensuring GMP compliance and real-time quality oversight across shifts. The role supervises QA Specialists and partners with Manufacturing to uphold batch records and approval processes.

The ideal candidate has a Master’s or Bachelor’s in a related field with several years of QA experience in biotech/pharma environments, strong leadership, and communication skills to drive continuous

Qualifications

• Master’s Degree with 2+ years in QA or DEA-related biotech/pharma.
• Bachelor’s Degree with 3+ years in QA or DEA-related biotech/pharma.

Responsibilities

• Directly supervise the AQL and QAOTF teams during manufacturing.
• Provide coaching, mentoring, and performance management for QA staff.
• Manage staffing, scheduling, workload balance, and shift coverage including evenings/weekends.
• Ensure QA coverage for production schedules and batch release activities.
• Support investigations, deviations, CAPAs, and change controls impacting manufacturing.
• Track and report department metrics and QA observations.

Skills

GMP knowledge

Root Cause Analysis

Technical Writing

Leadership

Communication

Education

Master’s Degree

Bachelor’s Degree

Tools

Microsoft Office

eQMS

LIMS

Job description

Product Quality Assurance Supervisor

The Product Quality Assurance Supervisor is responsible for 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 programs.
• 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 21 CFR 210, 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.