Sterility Assurance Specialist

4 weeks ago


Columbus, Ohio, United States American Regent, Inc. Full time
Job Summary

This role in the Sterility Assurance Department is responsible for ensuring the quality and integrity of our products. The successful candidate will be responsible for writing investigations and reports, as well as participating in technical projects from start to finish.

Key Responsibilities
  • Develop and implement technical protocols and reports for studies and trend analysis.
  • Conduct investigations for out-of-specification (OOS) or out-of-trend (OOT) results.
  • Plan and prioritize daily workload to meet project requirements.
  • Identify and report any issues related to Aseptic Technique or cGMP compliance.
  • Work independently with minimal supervision and manage Corrective and Preventive Actions (CAPAs).
  • Initiate Change Controls to procedures requiring modifications.
  • Complete gowning qualifications to enter the Aseptic Processing Areas (APA).
  • Address any quality issues that arise and bring them to management's attention.
Requirements
  • Bachelor's Degree in Microbiology, Biology, or a related field.
  • Minimum one-year experience in the pharmaceutical industry, food industry, or a similar FDA-regulated environment.
  • Knowledge of Aseptic Technique and Clean Room Experience preferred.
  • Strong technical writing skills and attention to detail.
  • Excellent communication and organizational skills.
  • Proficient in Microsoft Office and Trackwise or equivalent software.
Work Environment
  • Physically able to wear cleanroom/protective gowning and equipment.
  • Specific vision requirements include 20/40 near vision and color vision.
  • Job activities require long periods of sitting and/or standing.

American Regent, Inc. is an equal opportunity employer and celebrates diversity. We are committed to creating an inclusive environment for all employees.



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