Job Description
Company Information
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!
Overview:
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.
Responsibilities:
- 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
Qualifications / Skills:
- 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
Education, Experience, and Licensing Requirements: (Text Only)
- 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