Sterility Assurance Specialist

4 weeks ago


Columbus, Ohio, United States PharmaForce (Ohio) Full time
Job Summary

We are seeking a highly skilled Sterility Assurance Scientist to join our team at PharmaForce (Ohio). The successful candidate will be responsible for ensuring the sterility and quality of our products.

Key Responsibilities
  • Write technical protocols and reports for studies, trend reports, and other projects.
  • Investigate out-of-specification (OOS) or out-of-trend (OOT) results and implement corrective actions.
  • Plan and manage daily workload to meet requirements and deadlines.
  • Report any issues with Aseptic Technique or cGMP compliance to management.
  • Work independently with minimal supervision and manage Corrective and Preventive Actions (CAPAs).
  • Initiate Change Controls to procedures requiring modifications and complete gowning qualifications to enter the Aseptic Processing Areas (APA).
Requirements
  • Bachelor's Degree in Microbiology, Biology, or a related field.
  • Minimum one-year experience in the pharmaceutical industry, food industry, cosmetics, medical devices, laboratory pathology, or a similar FDA-regulated environment.
  • Knowledge of Aseptic Technique/Clean Room Experience preferred.
  • Technical writing skills required.
  • Organized individual with strong attention to detail and excellent communication skills (oral and written).
  • Proficient in Microsoft Office and Trackwise/MODA/LIMS or equivalent software.
Working Conditions

The successful candidate will be required to wear cleanroom/protective gowning and equipment, including but not limited to gowning, goggles, face shields, respirators, and protective gloves. PPE and respirators are essential for the health and safety of employees.

The job requires long periods of sitting and/or standing, and the employee must be able to occasionally lift and/or move up to 25 pounds.



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