Quality Assurance Engineer

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). Overview: The  Quality Assurance Engineer   is responsible for being the liaison between our generic clients and Charles City with regards to request for documentation to support their regulatory needs.

Overview:

The Quality Assurance Engineer  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. 

Responsibilities:

• 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. 
   

Qualifications / Skills::

• 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. 

Qualifications:

• BS or BA 

• 3-5 years of relevant experience preferably in a cGMP environment
• Experience at a commercial manufacturing facility for pharmaceuticals is strongly preferred.