Quality Assurance Senior Auditor
Cambrex2 days ago
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OnsiteFull-timeSenior
Summary
Cambrex is seeking a Quality Assurance Senior Auditor to join their team in Charles City, IA. The role involves serving 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.
About the Role
As a Quality Assurance Senior Auditor, you will lead supplier and internal audits, support regulatory inspections and customer interactions, approve analytical and method development documentation, and ensure data integrity and material release decisions. You will also provide mentorship to QA staff, support critical quality decisions, and drive continuous improvement to maintain inspection readiness and regulatory compliance.
About You
Required:
- 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.
- 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.
Preferred:
- Advanced coursework in Chemistry, Mathematics, or computer systems.
- 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.
Benefits
- Competitive benefits package including healthcare, life insurance, planning for retirement, and more.
- Opportunities for career and growth across a global network of locations.
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.
Charles City, IA