Microbiology QC Manager

Hess Associates - Winnipeg, MB (30+ days ago)

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Are you a responsible, experienced QC Manager with a strong pharmaceutical background, hoping to make a difference and ensure microbiology QC excellence?

Our Western Canada client excels in producing very specialized healthcare and bio-protection products, meeting the demanding needs of the marketplace. Your input would be much appreciated.

ROLE AND RESPONSIBILITIES:

  • All activities of the QC laboratory - staffing, testing of raw materials, products
  • (R&D, in-process or release stage), environmental samples.
  • SME on all nonclinical and clinical (GLP or GMP compliant) microbiological testing
  • at all stages up to licensure.
  • OOS. OOT, facility environmental and batch specific monitoring / testing.
  • Hiring, training entire QC Microbiology staff, including analysts and contractors,
  • allocating ample resources to projects.
  • Create a system that will ensure continuous improvement.
  • Meet required EHS standards.
  • Ensure SQIPP ( Safety, Quality, Identity, Purity, or Potency) standards met.
  • Review and approve unit procedures relating to testing, sampling, or related operations.
  • Technical data for regulatory submissions; take part in audits and CAPA; validations.
  • Budgets.

REQUIREMENTS:

  • B.Sc. Microbiology or related plus 5 to 7 years' QC experience.
  • Inclusive knowledge of GMPs and GLPs, and regulatory affairs.
  • Management background, able to create and lead effective, cohesive team of scientists.
  • Proven technical writer and communicator, able to analyze data and interpret results.
  • leading to excellent, workable, sound study protocols and reports.
  • Excellent leadership and interpersonal skills, able to lead teams and problem-solve effectively.
  • Budgets and P & L .

Reference ID: 2785

Job Type: Full-time

Benefits:

  • Company events
  • Dental care
  • Extended health care
  • On-site parking
  • Paid time off
  • Vision care

Schedule:

  • Monday to Friday

COVID-19 considerations:
as required by Province

Application question(s):

  • How many years of lab management experience do you have?
  • Do you require relocation?
  • Are you familiar with GMP and GLP?

Education:

  • Bachelor's Degree (required)

Experience:

  • Quality Control: 5 years (preferred)

Language:

  • English (required)

Work remotely:

  • No