Senior QA Auditor

You Matter to Cambrex.

Cambrex is a leading global contract development and manufacturing organization (CDMO) that provides drug substance development and manufacturing across the entire drug lifecycle, as well as comprehensive analytical and IND enabling services.

With over 40 years of experience and a team of 2,000 experts servicing global clients from North America and Europe, Cambrex offers a range of specialized drug substance technologies and capabilities, including continuous flow, controlled substances, liquid‑phase peptide synthesis, solid‑state science, material characterization, and highly potent APIs.

Your Work Matters.

At Cambrex, we strive to build a culture where all colleagues have the opportunity to:

• engage in work that matters to our customers and the patients they serve
• learn new skills and enjoy new experiences in an engaging and safe environment
• strengthen connections with coworkers and the community

We’re committed to attracting and nurturing a passionate team of valued professionals in our fast‑paced and growing company. We offer a competitive benefits package that includes healthcare, life insurance, planning for retirement, and more!

Your Future Matters.

Known for our customer‑focused scientific and manufacturing excellence, as well as our strong commitment to quality and safety, we offer a range of career and growth opportunities across our global network of locations. Together with our customers, we aim to improve the quality of life for patients around the world. Start a career where You Matter by applying today!

This role serves as a senior Quality Assurance subject‑matter expert responsible for final review and approval of analytical and batch records, oversight of SAP quality transactions, and leadership of OOS, deviations, investigations, and CAPA activities in compliance with cGMP requirements. Key responsibilities include leading supplier and internal audits, supporting regulatory inspections and customer interactions, approving analytical and method development documentation, and ensuring data integrity and material release decisions.

The position also provides mentorship to QA staff, supports critical quality decisions, and drives continuous improvement to maintain inspection readiness and regulatory compliance.

• Serve as a subject‑matter expert for In‑Process and Finished Goods Analytical Records (AR) and Batch Records (BR) review and final approval.
• Provide advanced oversight and approval of SAP quality transactions, including material determination and disposition decisions.
• Lead and approve Out of Specification (OOS), Deviations, and Investigations utilizing Track Wise, ensuring root cause analysis and CAPA effectiveness.
• Issue, review, and approve inspection, repackaging, and rework records with minimal oversight.
• Plan, lead, and report Critical Supplier and Quality Service Provider (QSP) audits, including follow‑up on corrective actions.
• Review and approve Raw Material Analytical Records and oversee material release decisions.
• Oversee Laboratory and Operations notebook issuance, ensuring compliance with data integrity and cGMP requirements.
• Act as a primary QA contact for customers, internal stakeholders, and regulatory inspections.
• Review and approve Method Validation, Analytical Development, and Method Development reports, providing compliance and technical guidance.
• Design, implement, and maintain cGMP training programs, including training materials, assessments, and effectiveness monitoring.
• Lead or co‑lead internal cGMP audits, including risk assessments, audit planning, execution, reporting, and CAPA tracking.
• Provide mentorship, guidance, and technical support to QA Auditors and Inspectors.
• Serve as a senior after‑hours QA resource on a rotational basis for critical quality decisions.
• Act as backup or escalation support for Raw Material inspections, sampling activities, and WFI water sampling when required.
• Support continuous improvement initiatives related to quality systems, audit readiness, and regulatory compliance.

All employees are required to adhere to DEA, EPA, FDA and cGMP regulations as they relate to the operation of the Company;…