On-the-Floor GMP QA Specialist

Augustbioservices; Nashville (TN); On-site; USD 65,000 - 95,000; Full time

Job summary

August Bioservices in Nashville, TN seeks a proactive QA Specialist to provide real-time quality oversight across manufacturing, packaging, inspection, and warehouse operations. You will ensure cGMP compliance, support production activities, and promote a strong quality culture on the floor.

The ideal candidate has 2–5 years of GMP-regulated experience, hands-on QA on-the-floor, and solid knowledge of FDA/ICH regulations and QA documentation practices.

Qualifications

• Bachelor’s degree in a scientific discipline or equivalent experience.
• 2–5 years in a GMP-regulated environment with on-the-floor QA support.
• Knowledge of cGMPs, FDA/ICH regulations, and QA documentation practices.
• Familiarity with MasterControl or electronic quality systems preferred.
• Strong communication, problem-solving, and interpersonal skills.
• Regular presence in GMP manufacturing and cleanrooms with gowning requirements.

Responsibilities

• Provide real-time QA support on the production floor and guide operators.
• Ensure adherence to batch records, SOPs, and validated procedures during manufacturing, packaging, and inspection.
• Perform QA line clearances, in-process checks, and AQL inspections; support visual and automated inspections.
• Act as a Designated Observer for controlled substance handling and regulatory compliance.
• Walk through production, lab, and warehouse areas to assess GMP compliance and elevate issues.
• Verify labeling issuance, reconciliation, and documentation for materials and finished products.
• Provide on-the-floor coaching to reinforce GMP compliance and best practices.
• Collaborate with Manufacturing and Planning to prioritize lot disposition and reduce downtime.
• Monitor cleaning, sanitization, and environmental controls before critical operations.
• Share lessons learned to promote a quality-focused culture; support deviation investigations.

Skills

QA Oversight

GMP Compliance

cGMP Regulations

Good Documentation

Education

Bachelor's degree in a scientific discipline

Tools

MasterControl

Electronic QA Systems

Job description

August Bioservices in Nashville, TN seeks a proactive QA Specialist to provide real-time quality oversight across manufacturing, packaging, inspection, and warehouse operations. You will ensure cGMP compliance, support production activities, and promote a strong quality culture on the floor.

The ideal candidate has 2–5 years of GMP-regulated experience, hands-on QA on-the-floor, and solid knowledge of FDA/ICH regulations and QA documentation practices.