active · Approximate location
Product Quality Assurance Supervisor
full timeNashville, Tennessee
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AT A GLANCE
QualitySupervisor level2+ years experienceFull Time
Required
- 2+ years experience
Headquartered in Nashville, TN – one of the fastest-growing and most exciting cities in the United States – August Bioservices is a privately-owned, high-growth, and high-impact Contract Development Manufacturing Organization (CDMO). As a US-based outsourcing partner that provid
About the role
Headquartered in Nashville, TN – one of the fastest-growing and most exciting cities in the United States – August Bioservices is a privately-owned, high-growth, and high-impact Contract Development Manufacturing Organization (CDMO). As a US-based outsourcing partner that provides a wide array of expert drug discovery, drug formulation, and drug manufacturing services to pharma and biotech companies of all sizes, we play a vital role in the global pharmaceutical industry. Our work is instrumental in helping to develop molecules today that can become the life-changing therapies of tomorrow. To support our growth plans, August is investing significant capital in a two-phase expansion project – including building a new state-of-the-art facility adjacent to our current facility. For those seeking dynamic opportunities, rewarding career paths and a chance to make a difference in global health, come grow with August!
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.
Requirements
- 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.
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