Quality Assurance Engineer

About the role

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.

The company strives to build a culture where all colleagues have the opportunity to engage in work that matters to customers and the patients they serve, learn new skills, and enjoy new experiences in an engaging and safe environment. Cambrex is committed to attracting and nurturing a passionate team of valued professionals in its fast-paced and growing company.

Responsibilities

The Quality Assurance Engineer is responsible for being the liaison between generic clients and Charles City with regards to requests for documentation to support their regulatory needs. This position also serves as a technical reviewer for internal projects and manages 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
• Review of customers' specifications, stability data, and providing standard statements of compliance
• Review of companies' technical documents
• Serve as a liaison with new and existing customers concerning regulatory filings
• Review of various change controls for compliance to commitments made in Regulatory Submissions or requirements and complete assessments of regulatory impact
• 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.

Qualifications

• 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
• BS or BA degree required
• 3-5 years of relevant experience preferably in a cGMP environment
• Experience at a commercial manufacturing facility for pharmaceuticals is strongly preferred

Benefits

Cambrex offers a competitive benefits package that includes healthcare, life insurance, planning for retirement, and more.