Quality Assurance Auditor I in Charles City, Iowa at Cambrex

QA Auditor I supports the Quality Assurance department by performing routine internal audits, reviewing quality systems, and assisting with compliance activities to ensure adherence to GMP, regulatory requirements, and company policies.

• 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
• CAPA initiation and review
• Raw Material (RM) Analytical Record - Review & Approval (combine into one)
• Operations Notebook Issuance
• Participate in quarterly internal cGMP audits
• Rotational coverage as an after hour QA resource
• Issuance & Approval Inspect and approve repackaging records

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.

• Strong oral and written communication skills
• Proficient in windows based environment including word processing, spreadsheet and database programs

• BS in Chemistry or a related field or equivalent industry relevant experience. Classes or education in Chemistry, Mathematics, Engineering, and computer software beneficial
• 3 or more years of experience in manufacturing environment, preferably pharmaceuticals
• Working knowledge of current good manufacturing practices and ICH Q7 and 21 CFR part 210 and 211 will be highly beneficial and preferred