QC Sterility Assurance Manager

Philadelphia Metro Area, PA

Job Type: Scientific Job Number: JN -042024-32346 Region: Philadelphia Metro Area

Job Description

Essential Functions and Responsibilities

  • Championing sterility assurance principals at the site in the areas of aseptic processing, and contamination control.
  • Support the site compliance to the global microbial control standards/procedures on environmental monitoring, critical utilities, contamination control strategy, clean-room management, microbiological methods and validations, sterilization and aseptic processing controls, disinfectant efficacy studies and microbial risk assessments.
  • Assist with the design of the contamination control strategy.
  • Develop and maintain the microbial contamination/Cross contamination risk assessment (HACCP).
  • Develop and maintain the EMPQ strategy and provides oversight of the EM testing program for regulatory compliance and technical soundness.
  • Participate in new product introduction teams as the sterility assurance SME to ensure new products/processes are designed with proper microbial controls.
  • Act as compliance and innovation subject matter expert during the selection and qualification of laboratory equipment for microbiological testing including Rapid Microbial Methods (RMMs).
  • Assist with relevant internal and external inspection responses/action items related to contamination control issues.
  • Establishes and implements appropriate training programs in collaboration with training leads.
  • Ensure alignment and harmonization regarding global microbiological/aseptic standards, policies, practices, procedures and compendial/regulatory requirements across sites.
  • Plays a critical role in facility design and modification, cleaning and sanitization program, operator qualification, gowning certification, manufacturing support, training, investigations, inspections, and audits.
  • Troubleshoots contamination related issues occurring in internal and external manufacturing sites.
  • Support site QC in microbiology deviations, LIR, OOS, Change controls and CAPA records.
  • Owns change control tasks associated with qualification or program revisions.
  • Regular communication to senior levels of management for issues related to contamination control.
  • Advanced knowledge of Microbiology, media, incubation conditions, microorganism isolation, identification, and enumeration techniques, etc.


Required Education, Skills, and Knowledge


  • Bachelor s degree in a relevant discipline (biological sciences or equivalent).
  • Minimum Six (6+) years of experience in the pharmaceutical industry within a Quality Control microbiology role.
  • Demonstrate knowledge of cGMP/ICH/FDA/EU compliance regulations and USP, EP and JP monographs for microbiology. Knowledge and familiarity with Annex 1.
  • Strong knowledge of microbiological and sterility testing, media fills, environmental monitoring, clean room qualification and management, quality control endotoxin, mycoplasma testing, and microbiological control strategy required.
  • Broad knowledge of quality control for biologics with experience in microbial contamination control.
  • Experience with microbiological risk assessments.


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