Sterile Manufacturing Expert

1 week ago

Mississauga, Ontario, Canada Resilience Full time

About Resilience

Resilience is a technology-focused biomanufacturing company revolutionizing the way medicine is made. Our mission is to build a sustainable network of high-tech, end-to-end manufacturing solutions that can withstand disruptive events, serve scientific discovery, and reach those in need.

Job Summary

The Senior Specialist II, QA Operations role at Resilience is a site-based position responsible for championing sterility assurance principles and serving as the microbial control technical leader. This individual will support site compliance to microbial/viral control standards/procedures and ensure GMP compliance with US FDA, Health Canada, EU requirements, and other regulatory bodies.

Main Responsibilities

  • Maintain site Contamination Control Strategy (CCS) and risk assessments related to Annex 1 and CCS compliance.
  • Lead site microbial and cross-contamination LOPA and HACCP risk assessments.
  • Support QC microbiology deviations, LIR, OOS, Change Control, and CAPA records by providing sterility assurance guidance.
  • Ensure alignment and harmonization regarding global microbiological/aseptic standards and compendial/regulatory requirements.
  • Support Aseptic Filling/Manufacturing surveillance and Quality Oversight of GMP activities.
  • Participate in new product introduction teams as the sterility assurance SME to ensure new products/processes are designed with proper microbial/viral controls.
  • Perform checks or audits on production activities to ensure all work is performed in full compliance with GMP, SOP, and related regulatory requirements.
  • Interface with clients, as required.
  • Collaborate and effectively communicate with internal customers, as necessary, to provide required documentation and/or resolve documentation or compliance issues.
  • Assist with the GMP and procedural training program for department's new hires and current employees, as required.
  • Address gaps and perform revisions to departmental SOPs, forms, and processes to streamline systems and ensure compliance to GxP and related company and regulatory requirements.
  • Provide proactive leadership in moving quality & compliance goals forward throughout the organization and achieving positive and value-added results.
  • Perform all other job-related duties as assigned by the Senior Manager, Quality Operations from time to time.

Requirements

  • Extensive experience in sterile manufacturing environments.
  • Strong knowledge of microbiological and sterility testing, media fills, environmental monitoring, clean room qualification and management, endotoxin testing, and microbiological control strategy.
  • Demonstrate knowledge of cGMP/ICH/FDA/EU/Health Canada compliance regulations.
  • Familiarity with Annex 1.
  • Excellent problem-solving, risk management, and communication skills.
  • Demonstrated good judgment and analytical skills.
  • Strong ability to network with senior leadership personnel.
  • Advanced competency in specific computer systems and applications.

Preferred Qualifications

  • Training in microbiology and sterility assurance is an asset.
  • University Bachelor's degree or degree recognized as equivalent by Canadian University/CANADIAN ACCREDITATION BODY in Microbiology, Chemistry, or related field.

This role requires vaccination for Hepatitis A and B and may include extended shifts. The estimated base salary range for this position is $90,000.00 - $131,250.00 per year, depending on qualifications and experience. Resilience offers a comprehensive benefits package, including health, dental, vision, life, LTD, and AD&D benefits, fertility healthcare and family-forming benefits, flexible time off, paid holidays, pregnancy and parental leave top-up plan, tuition reimbursement, and employee referral program.

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