QC MANAGER – MICROBIOLOGY

Accepting BioReady™: Yes
Category: Clinical Research
Education: Diploma/DEC
Experience: 4-6 Years
Salary:
Location: Mississauga, ON
Posted: March 25, 2020
Closes: April 25, 2020

Job description:

The QC Manager of Microbiology will manage the Microbiology Laboratory and ensure that all operations are conducted in compliance with cGMP regulations, company policies, safety standards and departmental procedures and standards. The incumbent will manage the execution of the environmental monitoring program, microbiological testing, method suitability, optimization and implementation to be consistent with client, production and regulatory requirements, and will assist the VP, Quality Operations in planning to maintain adequate resources (adequate pool of trained microbiology personnel, equipment and materials) necessary to efficiently execute Microbiology operations.

MAJOR RESPONSIBILITIES:

  • Manage personnel and ensure proper management of reagent, material and equipment resources to ensure accurate and timely completion and approval of Microbiology laboratory testing and records.
  • Manage the environmental monitoring program for the production facility.
  • Manage the implementation and execution of Microbiology laboratory control programs including: documentation control, sample control, method suitability control, laboratory investigations and out-of-trend/out-of specification investigations.
  • Establish & maintain Microbiology result trend analysis programs and approve reports as per schedule.
  • Approve results as per the current effective procedures.
  • Approve changes to ensure continuous improvement of Microbiology procedures (test methods and system SOPs).
  • Ensure creation of project test method suitability protocols to meet or establish the test method transfer/development/validation requirements (timelines/resources/cost estimates) for Microbiology testing for client manufacturing contracts.
  • Manage the execution of Microbiology test method development and optimization.
  • Oversee the creation, approval, training and implementation of Microbiology system SOPs, test methods and training modules.
  • Record and report according to established procedures any deviations from company procedures, or other discrepancies that may affect or indicate a problem with product quality; determine and implement any immediate corrective action as necessary; ensure the development of long term corrective action including identifying root causes; facilitate, review and approve final implementation of corrective action plans.
  • Ensure investigations, CAPAs and Change Controls are closed in a timely manner.
  • Ensure that applicable equipment and Microbiology instruments are qualified, maintained and calibrated.
  • Approve Microbiology IQ/OQ/PQ protocols and reports.
  • Approve Cleaning Validation and Performance Qualification protocols and reports.
  • Ensure that the Microbiology laboratory facilities and operations are in compliance with Safety and Environmental regulations, including chemical handling and disposal of laboratory waste.
  • Ensure all departmental staff is adequately trained to perform duties prior to performing a function.
  • Provide support to manufacturing from a microbiological perspective during investigations to help determine root cause and assist with determining corrective/preventative actions.
  • Manage technical issues to achieve cost effective operations within the Microbiology laboratory.
  • Create cost analyses for testing.
  • Research new technology.
  • Report and investigate Health and Safety incidents, accidents or potential hazards.
  • Work with Quality Assurance to establish and deliver required training programs in aseptic and sterile technique for lab and manufacturing personnel.
  • Perform all other related duties as assigned.

MINIMUM QUALIFICATIONS:

TECHNICAL KNOWLEDGE/EXPERIENCE:

  • Bachelor’s degree or Microbiology college diploma/certification together with 5-10 years related work experience
  • Demonstrated leadership and management skills
  • Strong working knowledge of Global Regulations, various compendia and cGMPs including Annex 1
  • Demonstrated leadership skills
  • Good working knowledge of aseptic techniques and microbial tests

PREFERRED QUALIFICATIONS:

  • Strong technical writing and computer skills
  • Good interpersonal and communication skills
  • Individual must be self-motivated, highly organized, and able to work in a fast paced manufacturing environment

ADDITIONAL REQUIREMENTS:

  • Pre-employment medical and medical re-examination performed every 2 years will be required as per Therapure’s SOPs.
  • This position requires vaccination for Hepatitis A and B

ADDITIONAL REQUIREMENTS:

  • Pre-employment medical and medical re-examination performed every 2 years will be required as per Therapure’s SOPs
  • This position requires vaccination for Hepatitis A and B

While we appreciate your interest in this opportunity, only qualified candidates will be contacted.

Therapure Biopharma Inc. will not be responsible for any agency referral fees arising from the use of resumes that currently exist in the recruitment database or have been forwarded to Therapure Biopharma directly or indirectly without an authorized agreement. Agency referrals will not be accepted unless approved by the Therapure Biopharma Inc. Human Resources team.

NOTE:All employment is conditional upon the completing and obtaining a satisfactory background check, including pre-employment medical (where applicable), educational, employment, references, and criminal records checks (for which a pardon has not been granted).

Therapure is committed to providing accessible employment practices that are in compliance with the Accessibility for Ontarians with Disabilities Act (AODA). Requests for accommodation can be made at any stage of the recruitment process. Applicants are asked to make their needs/requirements known to Human Resources

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