Cambrex ยท 4 days ago
Senior QA Auditor
Charles City, IA
Full-time
Onsite
Senior Level
5+ years expCambrex is a leading global contract development and manufacturing organization (CDMO) that provides drug substance development and manufacturing across the entire drug lifecycle. The Senior QA Auditor role serves as a subject matter expert responsible for the final review and approval of analytical and batch records, oversight of quality transactions, and leadership in compliance with cGMP requirements.
AnalyticsBiotechnologyInnovation ManagementManufacturingMarket ResearchPharmaceutical
Responsibilities
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 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
Qualification
Required
Demonstrated 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 (e.g., TrackWise, SAP)
Ability to mentor junior staff, manage multiple priorities, and exercise sound judgment in high-impact quality decisions
Bachelor's degree in Chemistry or a related scientific discipline, or equivalent industry experience
5-8+ years of progressive Quality Assurance experience in a regulated manufacturing environment, preferably pharmaceutical or CDMO
Preferred
Advanced coursework in Chemistry, Mathematics, or computer systems is beneficial
Benefits
Healthcare
Life insurance
Planning for retirement
Company
Cambrex
Cambrex is a small molecule company that offers drug substance, drug product, and analytical services.
1001-5000 employees
H1B Sponsorship
Cambrex has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (21)
2024 (19)
2023 (16)
2022 (15)
2021 (7)
2020 (8)
Funding
Current Stage
Public CompanyTotal Funding
unknown2019-08-07Acquired
1987-10-02IPO
Leadership Team
Tom Loewald
Chief Executive Officer
Robert Green
EVP & Chief Financial Officer
Recent News
Company data provided by crunchbase