At Cambrex, it’s our people that set us apart. We work locally and have an impact globally. We’re committed to attracting, nurturing and retaining a passionate and talented team of experts in our fast paced and growing company. You will be valued and recognized. We offer an exceptional benefits package including medical, dental, vision, Life, LTD, generous vacation in your first year, sick time, and retirement savings!
Cambrex is the small molecule company that provides drug substance, drug product and analytical services across the entire drug lifecycle. Known for our scientific and manufacturing excellence and customer focus, we offer a range of career opportunities across our global network of locations. As a team, we share one goal – to improve the quality of life for our customers’ patients across the world.
The Quality Assurance Engineer I is responsible for being the liaison between our generic clients and Charles City with regards to request for documentation to support their regulatory needs. This position also is a technical reviewer for internal projects such as stability protocols and reports, analytical method protocols and reports as well as managing customer complaints.
- Key Quality Assurance customer support person to answer, address and/or compile relevant data to support Cambrex Charles City, Inc. products through customer requests through, but not limited to: Review of customers specification, Stability Data, Providing Standard statements of compliance
- Review of companies technical documents
- Serve as a liaison with new and existing customers concerning regulatory filings (i.e. coordinating issuance of CEPs, Letters of Authorization, coordinate filings of EDMF/CDMF with MAA, coordinate responses to customer inquiries).
- Review of various change controls for compliance to commitments made in Regulatory Submissions or requirements and complete assessments of regulatory impact.
- Review of data/records received from R&D, manufacturing, analytical, supply chain and Quality Assurance departments for corresponding with customers for regulatory support.
- Compile and author Annual Product Quality Reviews
- 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.
- BS or BA
- 3-5 years of relevant experience preferably in a cGMP environment
- Ability to maintain written and oral communication in English required.
- Strong critical thinking skills
- Strong interpersonal and leadership skills, including initiative and strong work ethic.
- Experience at a commercial manufacturing facility for pharmaceuticals is strongly preferred.
Cambrex is an Equal Opportunity / Affirmative Action employer and will consider all qualified applicants for employment without regard to race, color, religion, gender, sexual orientation, gender identity, national origin, age, protected veteran status, or disability status.