QA Auditor I

8/3/22

Charles City, IA

1779

1779 QA Auditor I

Responsibilities

  • In Process/Finished Goods (FG) Analytical Record (AR) and Batch Record (BR) - Review & Approval
  • SAP transactions including material determination
  • Out Of Specification, Deviation, Investigation review and approvals utilizing TrackWise
  • Issuance & Approval Inspect and approve repackaging records
  • Critical Supplier Audits
  • Raw Material (RM) Analytical Record - Review & Approval
  • Laboratory and Operations Notebook Issuance
  • Quality Service Provider (QSP) Audits
  • Customer Internal/External Contact
  • Method Validation Reports, Analytical Development , Method Development - Review & Approval
  • Design and issue cGMP training materials and assessment tests
  • Participate in or lead 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

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

  • 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
  • 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

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