Job ID: 2024-3994 Type: Regular Full-Time # of Openings: 1 Category: Quality Assurance Cambrex - Charles City
Overview
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).
Responsibilities
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 & Approval Inspect 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
Qualifications
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
