Senior QA Auditor

Job Description Company InformationYou 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 environmentstrengthen connections with coworkers and the communityWe’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 moreYour Future Matters. Job OverviewThis 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. ResponsibilitiesServe 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 TrackWise, 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; and to adhere to all company safety rules and procedures. All employees are expected to report to work regularly and promptly. Other duties relating to departmental mission, not specifically detailed in this section may be assigned. Qualifications/SkillsDemonstrated expertise in cGMP regulations, including 21 CFR Parts 210/211, ICH Q7, and regulatory inspection readiness.Proven experience leading audits, investigations, and complex quality decisions with minimal supervision.Strong oral and written communication skills, including interaction with customers and regulatory agencies.Proficient in Windows-based systems, including word processing, spreadsheets, databases, and electronic quality systems TrackWise, SAP).Ability to mentor junior staff, manage multiple priorities, and exercise sound judgment in high-impact quality decisions. Education, Experience & Licensing RequirementsBachelor’s degree in Chemistry or a related scientific discipline, or equivalent industry experience. Advanced coursework in Chemistry, Mathematics, or computer systems is beneficial.5–8+ years of progressive Quality Assurance experience in a regulated manufacturing environment, preferably pharmaceutical or CDMO. Cambrex is committed to providing a safe and productive work environment. All offers of employment are contingent on the successful completion of a comprehensive pre-employment screen. The pre-employment screen may consist of several components including but not limited to a drug test, criminal record check, identity verification, reference checks, education and employment verification, and may vary based on federal, state, and local laws. Refusal to submit to testing will result in disqualification of further employment consideration. All requirements are subject to possible modifications to reasonably accommodate individuals with disabilities. Cambrex Corporation is an Equal Opportunity / Affirmative Action employer and will consider all qualified applicants for employment without regard to race, color, religion, sex (including pregnancy, sexual orientation, or gender identity), ancestry, national origin, place of birth, age, marital status, disability/handicap, genetic information, veteran status, or other characteristics protected by federal, state, and/or local law.