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2nd shift-Quality Manager, Microbiology

Job Attributes

Job Id:

24952

Job Category:

Clinical & Life Sciences

Job Location:

Boothwyn, PA  19061

Security Clearance:

No Clearance

Business Unit:

Piper Companies

JOB DESCRIPTION

 

Piper Companies is looking for a Quality Manager, Microbiology for 2nd shift to ensure compliance of operations, assessing the conformance of manufacturing operations to GMP requirements and Microbiology quality of products for a Pharmaceutical Manufacturer in Boothwyn, PA.

Responsibilities for the Quality Manager, Microbiology include:

  • Responsible for coordination of QA/QC specific to Microbiology staff and their Environmental Monitoring (EM) functions
  • Maintain the EM program, Performs EM sampling as needed
  • Participate in lab design and set-up, including equipment set-up/qualification
  • Microbiological requirements of the Raw Material testing program
  • Product release Testing: Sterility/Endotoxin and other Microbiological tests as needed
  • Management review of QA Microbiology investigations, laboratory deviations, OOS / OOT results, etc.
  • Reviews and updates Standard Operating Procedures (SOPs)
  • Performs peer review and trending of data.
  • Participates in execution of validation protocols.
  • Reviews laboratory investigation reports (inclusive if provided by third party purveyor).
  • Helps with receipt / sampling / testing / release of raw materials and products.  Monitors, performs and documents sampling / testing and inspection of raw materials / components / in-process samples and documents the results in compliance with cGMP and company procedures.
  • Accurately performs in-process inspections.
  • Reviews completed batch records and issues batch records and associate forms to production.
  • Helps conduct investigations of process deviations

Qualifications for the Quality Manager, Microbiology include:

  • Bachelor’s degree in a life science or related field of study.
  • 7-10 years of related experience in cGMP
  • Previous experience in operating and adjusting various equipment for purposes such as performing standardized test or operations, requiring considerable training and experience
  • Previous experience within QA/QC and Environmental Monitoring.
  • Previous experience with Sterility and Endotoxin testing as well as with validation of standard and rapid microbial methods.
  • Previous experience entering information into a data warehouse system (i.e. Cornerstone LMS)
  • Proficiency in MS PowerPoint

 Compensation for the Quality Manager, Microbiology include:

  • $80,000 - $90,000

 

Please send resume to KarenPallone: kkpallone@pipercompanies.com

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New Search

Job Id:

24952

Job Category:

Clinical & Life Sciences

Job Location:

Boothwyn, PA  19061

Security Clearance:

No Clearance

Business Unit:

Piper Companies