On‑Floor QA Specialist: Real‑Time GMP Oversight & Guidance

Augustbioservices; Nashville (TN); On-site; USD 65,000 - 90,000; Full time

Job summary

August Bioservices in Nashville, TN is seeking a proactive QA Specialist to provide real-time quality oversight across manufacturing, packaging, inspection, and warehouse operations.

The role focuses on ensuring cGMP compliance, guiding operators, and supporting batch records, deviations, and CAPA investigations. Candidates should be hands-on, detail-oriented, and capable of fostering a strong quality culture.

2nd/3rd shifts; weekend coverage may be required.

Qualifications

• 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.

Responsibilities

• Provide real-time QA support on the production floor and guidance to operators.
• 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 and automated inspection processes.
• Act as a Designated Observer for controlled substance handling, ensuring compliance with internal and regulatory requirements.
• Collaborate with Manufacturing and Planning teams to prioritize lot disposition and minimize downtime.
• Monitor cleaning, sanitization, and environmental controls prior to critical operations.
• Maintain knowledge of deviation, OOS/OOT, and CAPA processes to support investigations.

Skills

Communication

Problem-solving

Interpersonal skills

Education

Bachelor’s degree in a scientific discipline

Tools

MasterControl

Job description

August Bioservices in Nashville, TN is seeking a proactive QA Specialist to provide real-time quality oversight across manufacturing, packaging, inspection, and warehouse operations.

The role focuses on ensuring cGMP compliance, guiding operators, and supporting batch records, deviations, and CAPA investigations. Candidates should be hands-on, detail-oriented, and capable of fostering a strong quality culture.

2nd/3rd shifts; weekend coverage may be required.