active · Approximate location
QA Specialist - On the Floor Support (3rd Shift)
full timeNashville, Tennessee
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AT A GLANCE
Quality5+ years experienceFull Time
Required
- 5+ 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!
We are seeking a proactive QA Specialist to provide real-time quality oversight across manufacturing, packaging, inspection, and warehouse operations. The role ensures cGMP compliance, supports production activities, and promotes a strong quality culture. The ideal candidate is detail-oriented, hands-on, and able to provide guidance to operators while maintaining inspection readiness.
Responsibilities
- Maintain a daily presence on the production floor to provide real-time QA support and guidance.
- Ensure adherence to batch records, SOPs, and validated procedures during manufacturing, packaging, and inspection activities.
- Perform QA line clearances, in-process checks, and AQL inspections, and support visual inspection and automated inspection processes.
- Act as a Designated Observer for controlled substance handling, ensuring compliance with internal and regulatory requirements.
- Routinely walk through production, lab, and warehouse areas to assess GMP compliance and escalate issues as needed.
- Verify labeling issuance, reconciliation, and documentation to ensure proper handling of materials and finished products.
- Provide on-the-floor coaching and guidance to operators, reinforcing GMP compliance and best practices.
- Collaborate with Manufacturing and Planning teams to prioritize lot disposition, minimize downtime, and support operational flow.
- Monitor cleaning, sanitization, and environmental controls prior to critical operations.
- Promote a quality-focused culture by sharing lessons learned and encouraging proactive issue identification.
- Maintain knowledge of deviation, OOS/OOT, and CAPA processes to support investigations if required.
- Assist in gathering facts, reviewing documentation, and providing QA input when deviations occur on the floor.
- Understand root cause analysis tools (5 Whys, Fishbone, FMEA) to support quality discussions.
- Review, revise, and proofread GMP documentation, including batch records, SOPs, and logbooks.
- Support document control processes and ensure training documentation is correctly linked to controlled systems.
- Ensure compliance with regulatory standards (FDA, ICH, DEA) and Good Documentation Practices.
- Conduct routine walk-throughs to maintain inspection readiness.
- Support internal audits and regulatory inspections by providing floor-level guidance and documentation as needed.
Requirements
- Bachelor’s degree in a scientific discipline or equivalent experience.
- 2–5 years in a GMP-regulated environment, with experience in on-the-floor QA support.
- Knowledge of cGMPs, FDA/ICH regulations, and QA documentation practices.
- Familiarity with Master Control or electronic quality systems preferred.
- Strong communication, problem-solving, and interpersonal skills.
- Regular presence in GMP manufacturing and cleanroom environments with proper gowning.
- Occasional off-shift, weekend, or extended coverage may be necessary.
- Experience with automated visual inspection processes.
- Knowledge of controlled substance handling.
- Prior involvement in regulatory inspections.
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