Quality Control, Quality Assurance & Microbiology

Quality Control & Quality Assurance

Quality Control is responsible for sample testing to fulfil the quality requirements of Health Canada, FDA and International Regulatory bodies. Quality Assurance ensures that production materials meet quality specifications and are compliant with regulatory guidelines through our planned and systematic quality systems. The primary purpose and mission of the department is to analyze the microbiological nature and make-up of substances, using a variety of modern microbiological techniques, methods and instrumentation for its customers in a highly efficient, cost effective and timely manner.

The Microbiology department is involved in work as diverse as microbiological analysis, quality control, environmental monitoring and trending, microbiological support activities for sterile manufacture, microbiological method development and validation as well as microbiological support for manufacturing process development as required.

We are always looking for new people to contribute to the company's growth. We offer a competitive salary and benefits and an excellent opportunity to build your career with a growing company. Thank you for your interest in working at Dalton Pharma. Please note that successful applicants will be notified by email within 2 weeks if they are selected for an interview. We do keep resumes on file. If we have an opening that better fits your career goals and experience, we will contact you.

Please forward your resume to:

Human Resources Department
Dalton Pharma Services Inc.
Email:

POSITIONS CURRENTLY AVAILABLE:

Microbiology Supervisor

The Microbiology Supervisor will be responsible in performing microbial testing, using a variety of techniques, methods and instrumentation, to ensure products are safe for human use and meet the pre-determined quality specifications. The Microbiology Supervisor ensures that the Dalton Pharma Services facility meets pre-established criteria by conducting environmental monitoring, utilities testing and trending. The Microbiology Supervisor will also conduct microbiological method development and validation to meet client needs and regulatory requirements.

Responsibilities:
  • Prepare schedule, assign daily tasks and provide guidance to the microbiologists.
  • Conduct microbial testing of raw materials, in-process samples, finished products, utilities and EM of facilities using various techniques.
  • Perform all microbiology testing in compliance with cGMP regulations, following internal, client and compendial methodologies.
  • Review data generated by microbiologists for accuracy and compliance.
  • Write and/or approve SOP revisions.
  • Write/execute method and validation protocols, and sign-off reports.
  • Perform investigations for product and environmental monitoring excursions, identify root cause and make CAPA recommendations.
  • Review processes in the microbiology department to identify opportunities and make recommendations for improvement.
  • Participate in client and regulatory audits and assist with responses/CAPA generation, as needed.
  • Act as back-up to the Microbiology Manager.
Requirements:
  • Knowledge of regulatory requirements (Health Canada, FDA and EU) for microbiology testing related to the manufacturing of sterile and non-sterile pharmaceutical products./li>
  • B.Sc. or higher degree in Microbiology
  • 2 or more years of experience as a Microbiology Supervisor, responsible for a team of microbiologists
  • Supported by 5 or more years of microbiology laboratory experience within a biotechnology/pharmaceutical aseptic manufacturing environment facility. OR/li>
  • B.Sc. or higher degree in Microbiology
  • 5 or more years of experience as a Senior Microbiologist/Team Lead
  • Supported by 10 or more years of microbiology laboratory experience within a biotechnology/pharmaceutical aseptic manufacturing environment facility.
  • Experience in aseptic techniques and microbiology testing, including validation, related to the manufacturing of sterile and non-sterile pharmaceutical products. Testing includes, but is not limited to: environmental monitoring, microbial enumeration, microbial identification, growth promotion, endotoxin testing, disinfectant qualification, bacterial retention/filter validation, ingress testing, media fill processing.
  • Knowledgeable in the gowning qualification process and MUST be able to be gown qualified and work in an aseptic environment.
  • Experience in good laboratory documentation practices and regulatory guidelines e.g. SOPs, Pharmacopeias
  • Knowledge of Annex 1 guidelines is a definite asset.
  • Strong oral/written communication and interpersonal/leadership skills.
  • Strong investigative and problem-solving abilities, and report writing skills
  • Proficient in the use of Microsoft software and EQMS software such as Trackwise or Dot Compliance.

While we appreciate all applications received, only those selected for an interview will be contacted.

Job Types: Full-time, Permanent

Benefits:
  • Casual dress
  • Dental care
  • Disability insurance
  • Employee assistance program
  • Extended health care
  • Flexible schedule
  • Life insurance
  • On-site Parking
  • RRSP match
  • Tuition reimbursement
  • Vision care
Application question(s):
  • Are you comfortable with fully on-site work arrangement at our North York location?
  • Do you have experience with Annex 1 compliance & gap analysis?
Education:
  • Bachelor's Degree (preferred)
Experience:
  • Microbiology Supervisor : 2 years (required)
  • Microbiology (biotechnology/pharmaceutical ): 10 years (required)

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