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 I supports the Quality Assurance department by performing routine internal audits, reviewing quality systems, and assisting with compliance activities to ensure adherence to GMP, regulatory requirements, and company policies.
Responsibilities:
- In Process/Finished Goods (FG) Analytical Record (AR) and Batch Record (BR) - Review
- SAP transactions
- Out Of Specification, Deviation, Investigation support and review utilizing TrackWise
- CAPA initiation and review
- Raw Material (RM) Analytical Record - Review & Approval (combine into one)
- Operations Notebook Issuance
- Participate in quarterly internal cGMP audits
- Rotational coverage as an after hour QA resource
- Issuance & Approval Inspect and approve repackaging records
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 / Skills:
- 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)
- 3 or more years of experience in manufacturing environment, preferably pharmaceuticals
- Working knowledge of current good manufacturing practices and ICH Q7 and 21 CFR part 210 and 211 will be highly beneficial and preferred