Quality Assurance Auditor - Cambrex

The Quality Assurance (QA) Auditor is responsible for ensuring compliance with regulatory standards and internal quality requirements in the manufacturing process. This position plays a key role in maintaining product quality and safety by reviewing, auditing, and inspecting batch records, finished goods, and raw materials. Additionally, the QA Auditor will oversee several critical quality control processes, participate in internal audits, and monitor corrective and preventive actions (CAPA).

Accountabilities and 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 

• Issuance & ApprovalInspect and approve repackaging records  

• Raw Material  (RM) Analytical Record - Review & Approval 

• Laboratory and Operations Notebook Issuance 

• Participate in quarterly internal cGMP audits. 

• Rotational coverage as an after hour QA resource 

• Back up to QA Inspector for Raw Material Inspections and Sampling including WFI water samples 

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 work processing, spreadsheet and database programs 

• BS in Chemistry or a related field or equivalent industry relevant experience.  Classes or education in Chemistry, Mathematics and computer software beneficial 

• 3 or more years of experience in manufacturing environment, preferably pharmaceuticals