On-Floor QA Lead: Visual Inspection & Compliance

August Bioservices, LLC

Nashville (TN)

On-site

USD 90,000 - 115,000

Full time

7 days ago
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Job summary

August Bioservices, LLC in Nashville, TN seeks a Quality Assurance professional to lead the AQL Visual Inspection and on-the-floor quality oversight within a fast-paced CDMO environment. This role requires strong QA leadership and a focus on continuous improvement.

The incumbent will collaborate with manufacturing to develop inspection qualifications, review SOPs and batch records, train QA staff, and ensure compliance with cGMP and FDA requirements.

Qualifications

  • 4 years of AQL inspection experience in the pharmaceutical industry with liquid and lyophilized products.
  • Quality Engineer Certification preferred.
  • Highly organized with strong attention to detail and ability to manage time and priorities effectively.

Responsibilities

  • Develop, implement and oversee the QA AQL Visual Inspection / On-The-Floor program.
  • Collaborate with manufacturing to classify rejects and establish AQL levels.
  • Lead qualification kits and operator training for on-the-floor QA.
  • Review SOPs, batch records, and deviation reports for quality compliance.
  • Support internal and external regulatory inspections and CAPA processes.
  • Ensure presence in production areas and provide real-time batch record oversight.

Skills

AQL inspection
QA oversight
cGMP compliance
Attention to detail
Cross-functional communication

Education

Bachelor’s degree in science or related discipline

Job description

August Bioservices, LLC in Nashville, TN seeks a Quality Assurance professional to lead the AQL Visual Inspection and on-the-floor quality oversight within a fast-paced CDMO environment. This role requires strong QA leadership and a focus on continuous improvement.

The incumbent will collaborate with manufacturing to develop inspection qualifications, review SOPs and batch records, train QA staff, and ensure compliance with cGMP and FDA requirements.

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