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Sterility Assurance Specialist

Job Attributes

Job Id:

20681

Job Category:

Clinical & Life Sciences

Job Location:

Exton, PA  19341

Security Clearance:

No Clearance

Business Unit:

Piper Companies

JOB DESCRIPTION

 

Piper Companies is looking for a Sterility Assurance Specialist to support the maintenance of all sterilization activities as well as assisting with the development of a Stability Assurance Program for a Manufacturing Company in Exton, PA.

Responsibilities for the Sterility Assurance Specialist include:

  • Own sterilization activities for products manufactured at site
  • Maintain testing programs for assurance of patient safety including sterile product release and contamination control
  • Technical liaison between internal/external laboratory microbiological testing functions
  • Perform audits of contract facility applying international regulatory standards as well as ISO 13485
  • Coordinate supplier compliance to company sterilization sciences
  • Review and approval of new processes and changes to existing processes
  • Oversee Environmental Program and Controlled Environment qualification
  • Support viral inactivation studies resk assessments
  • Support execution of zoonosis reports

 

Qualifications for the Sterility Assurance Specialist include:

  • BS degree in Biological Science
  • Minimum 5 years experience within the medical device/pharmaceutical industry
  • Support review of sterilization batch records and the release of Ethylene Oxide (EO) 
  • Quality standards: ISO 13485, ISO 11135, ISO 11137 & MDD
  • FDA Regulations & Guidelines, 21CFR820, GMP
  • Excellent knowledge of quality management systems
  • Knowledge of systems: Microsoft Office, SAP, & Document Management Systems

Compensation for the Sterility Assurance Specialist include:

  • Salary Range: $75,000 - $85,000
  • Full benefits package

 

Please send resume to Derek Herbine: dherbine@pipercompanies.com

Keywords: Sterility, Sanitation, Contamination, QA, Quality Assurance, Pharmaceutical, Medical Device, Polymer, Plastic, Extrusion, FDA, Regulations, ISO 13485, Bachelors, Benefits, Controlled Environment, Zoonosis, Validation, SAP, cGMP, Batch Records, Ethylene Oxide, Document Management Systems, Quality standards, ISO 13485, ISO 11135, ISO 11137, MDD, Exton, Philadelphia, PA,

 

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New Search

Job Id:

20681

Job Category:

Clinical & Life Sciences

Job Location:

Exton, PA  19341

Security Clearance:

No Clearance

Business Unit:

Piper Companies