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Sterility Assurance Specialist

Job Attributes

Job Id:

20544

Job Category:

Clinical & Life Sciences

Job Location:

Philadelphia, PA  19123

Security Clearance:

Not Defined

Business Unit:

Piper Companies

JOB DESCRIPTION

Piper Companies is looking for a Sterility Assurance Specialist for a growing Philadelphia based medical device company. The Sterility Assurance Specialist will ensure the execution of site contamination control policies and procedures while working in partnership with Supplier Quality Assurance team to drive continual improvement in the sterilization processes and services.

Responsibilities for the Sterility Assurance Specialist include: 

  • Responsible for sterilization activities performed on products manufactured at site.
  • Serve as technical liaison to internal and external laboratory microbiological testing functions including performing audits of the contract facility utilizing international regulatory standards as well as ISO 13485.
  • Coordinate supplier compliance to company sterilization sciences and biological safety systems and standards including authoring and reviewing validations and product adoptions into existing processes.
  • Oversee the Environmental Monitoring Program and Controlled Environment qualification activities and implement and maintain adherence to Controlled Environment policies and procedures.
  • Support execution of annual zoonosis reports and literature reviews for animal derived product.

 Requirements for the Sterility Assurance Specialist include:

  • Bachelor’s degree in Biological science with 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
  • knowledge of systems: Microsoft Office, SAP, & Document Management Systems

Compensation for the Process Engineer include:

  • Salary between $75,000-$85,000
  • Full Benefits

Keywords:

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

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Job Id:

20544

Job Category:

Clinical & Life Sciences

Job Location:

Philadelphia, PA  19123

Security Clearance:

Not Defined

Business Unit:

Piper Companies