Senior QA Audit Lead — cGMP Biotech & Compliance

CAMRIS; Silver Spring (MD); On-site; USD 110,000 - 160,000; Full time

Job summary

CAMRIS is seeking a Senior Quality Assurance Audit Specialist to support the Pilot Bioproduction Facility at WRAIR in Silver Spring, MD. The role focuses on ensuring cGMP compliance, reviewing batch records, and leading QA investigations.

The ideal candidate will have a BS/BA in biology or life sciences with 10 years’ experience, and at least 4 years in QA within a cGMP biotech/pharma setting. Strong communication and ability to coach staff are essential.

Qualifications

• BS/BA in biology or life science with 10 years of experience; Master’s degree preferred.
• At least 6 years at a cGMP biotechnology/pharma facility with 4+ years in QA.
• Strong written and verbal communication with attention to detail; able to work independently.

Responsibilities

• Provides comprehensive quality support to ensure cGMP compliance, including SOPs, batch records, and on‑the‑floor audits.
• Leads in implementing and revising quality system projects and documents.
• Maintains understanding of QA systems and follows SOPs for all work activities.
• Supports investigations and verifies CAPAs are implemented effectively.
• Assists in deviations, labeling reviews, and internal audits to improve compliance.
• Coaches staff to enhance GMP understanding and practice; ensures training adherence.
• Serves as emergency responder for inventory protection during freezer/refrigerator failures.

Skills

GMP compliance

Audit execution

Documentation review

Mentoring staff

Education

BS/BA in biology or life science

Master’s degree preferred

Tools

MS Word

MS Excel

MS Access

LIMS systems

Job description

CAMRIS is seeking a Senior Quality Assurance Audit Specialist to support the Pilot Bioproduction Facility at WRAIR in Silver Spring, MD. The role focuses on ensuring cGMP compliance, reviewing batch records, and leading QA investigations.

The ideal candidate will have a BS/BA in biology or life sciences with 10 years’ experience, and at least 4 years in QA within a cGMP biotech/pharma setting. Strong communication and ability to coach staff are essential.