Quality Assurance Auditor II in Charles City, Iowa at Cambrex

QA Auditor II supports the Quality Assurance function by conducting internal audits, supplier audits, and compliance assessments to ensure adherence to GMP, regulatory requirements, and company quality standards. This role helps identify risks, drive corrective and preventive actions (CAPAs), and promote continuous improvement across operations. The QA Auditor II works cross-functionally with manufacturing, laboratory, and support teams to maintain inspection readiness and support the delivery of safe, high-quality pharmaceutical products for clients.

• In Process/Finished Goods (FG) Analytical Record (AR) and Batch Record (BR) - Review & Approval
• SAP transactions including material determination
• Out Of Specification, Deviation, Investigation review and approvals utilizing TrackWise
• CAPA (same as auditor I)
• Issuance & Approval Inspect and approve repackaging records
• Critical Supplier Audits
• Raw Material (RM) Analytical Record - Review & Approval (combine with bullet one)
• Operations Notebook Issuance
• Quality Service Provider (QSP) Audits
• Customer Internal/External Contact
• Method Validation Reports, Analytical Development , Method Development - Review & Approval
• Design and issue cGMP training materials and assessment tests
• Participate in or lead quarterly internal cGMP audits.
• Rotational coverage as an after-hour QA resource
• KPI reporting

• Working knowledge of current good manufacturing practices and ICH Q7 and 21 CFR part 210 and 211 will be highly beneficial and preferred
• Strong oral and written communication skills
• Proficient in windows based environment including word processing, spreadsheet and database programs

• BS in Chemistry or a related field or equivalent industry relevant experience. Classes or education in Chemistry, Mathematics, Engineering, and computer software beneficial
• 3 or more years of experience in Quality Assurance in a manufacturing environment, preferably pharmaceuticals