August Bioservices

QA Specialist - On the Floor Support (2nd Shift, 3rd Shift, & Weekend Shift)

Nashville, Tennessee

Sponsorship not specifiedDetected 267 days ago

GMPFDA RegulatoryCommunicationProblem SolvingMentoring

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).
The ideal candidate is detail-oriented, hands-on, and able to provide guidance to operators while maintaining inspection readiness.
Everything we do, we do with great care.

Maintain a daily presence on the production floor to provide real-time QA support and guidance.
Perform QA line clearances, in-process checks, and AQL inspections, and support visual inspection and automated inspection processes.
Collaborate with Manufacturing and Planning teams to prioritize lot disposition, minimize downtime, and support operational flow.
Understand root cause analysis tools (5 Whys, Fishbone, FMEA) to support quality discussions.
Support document control processes and ensure training documentation is correctly linked to controlled systems.
Conduct routine walk-throughs to maintain inspection readiness.
Support internal audits and regulatory inspections by providing floor-level guidance and documentation as needed.
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.
The role ensures cGMP compliance, supports production activities, and promotes a strong quality culture.

Bachelor's degree in a scientific discipline or equivalent experience.
Knowledge of cGMPs, FDA/ICH regulations, and QA documentation practices.
Maintain knowledge of deviation, OOS/OOT, and CAPA processes to support investigations if required.
2-5 years in a GMP-regulated environment, with experience in on-the-floor QA support.
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.
Work Environment & Physical Demands
ADA Accommodation Notice
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.
Physical Requirements
Ability to safely wear and work in a PAPR hood and associated equipment weighing approximately 2 to 3 pounds during assigned tasks.

For those seeking dynamic opportunities, rewarding career paths and a chance to make a difference in global health, come grow with August!
shift, weekend, or extended coverage may be necessary.

At August Bioservices, Our Credo is our culture.
We are committed to doing the right thing the first time and every time, meeting or exceeding all regulatory requirements.
We are August Bioservices.
We are pointing the way forward.
We are seeking a proactive QA Specialist to provide real-time quality oversight across manufacturing, packaging, inspection, and warehouse operations.

This listing is sourced directly from August Bioservices's careers page and normalized into a canonical job model.