Dalton Pharma Services is a leading partner in the development and manufacture of medicines and drugs for a healthier world. We develop and manufacture innovative new products that positively impact the lives of people across the globe. Our customers range from the largest pharmaceutical companies in the world to the smallest start-ups working on the next innovation in healthcare and wellness.
We are currently looking for an experienced Microbiologist to work in a pharmaceutical manufacturing environment.
Roles and responsibilities:
- Maintain documentation, including lab notebooks, equipment logbooks and microbiological data.
- Perform all activities in compliance with GLP/GMP guidelines & Dalton SOPs.
- Work in a very fast paced environment performing duties within required timelines, including:
- Routine Environmental monitoring of Grade A to D and support areas
- Routine Environmental monitoring of aseptic environments GRADE A/B
- Environmental monitoring of aseptic environments GRADE A/B and personnel during Production/Media Fills
- Read EM plates, isolate, purify and identify microorganisms (Bacteria and Molds) with particular attention to pathogenic microorganisms
- Gram staining and microscopic examination of slides
- Perform trend analysis of viable and non-viable data obtained from the GMP area
- Inspect/transfer media filled vials
- Conduct growth promotion testing and microbial ingress test
- Receive media/reagent/components
- Prepare media and reagents
- Complete safety and laboratory inventory check lists
- Clean of work benches and laboratory equipment
- Conduct endotoxin testing and microbial testing/identification, as needed, on raw materials, intermediates, products and water
- Conduct Bacterial retention studies
- Complete alert/action level forms and updates.
- Provide microbiological documentation support to Customer Service, Business Development and Product Development departments as required.
- Write method and EM validation protocols and reports. Approve reports written by other team members.
- Identify procedural/process and GMP gaps. Write and update SOPs for the microbiology laboratory and provide support for department SOPs.
- Provide training to new employees and/or new procedures.
- Provide support as per audit requirements and implement audit observation corrections.
- Attend client meetings
- Investigate/write deviations and develop CAPAs
- Distribute and schedule work among the team members.
- Communicate with other departments to facilitate work in order to meet project deadlines.
- Identify cost savings without compromising the quality.
- Perform ARF data review/ARF QC release
- Back-up to the Microbiology Supervisor
- Perform other duties as assigned by management.
Requirements:
- B.Sc. or higher degree in Microbiology or related degree/diploma
- 2-5 or more years of experience in a microbiology laboratory in a pharmaceutical company OR
- Diploma in Microbiology or a related field
- 4-7 or more years of experience in a microbiology laboratory in a pharmaceutical company (more years of experience in a non-pharmaceutical setting will be considered)
Job Types: Full-time, Permanent
Pay: $55,000.00-$65,000.00 per year
Benefits:
- Casual dress
- Company events
- Dental care
- Disability insurance
- Employee assistance program
- Extended health care
- Life insurance
- On-site parking
- RRSP match
- Vision care
- Wellness program
Application question(s):
- Are you comfortable to work 5 days per week on-site?
Education:
- Bachelor's Degree (preferred)
Experience:
- Pharmaceutical microbiology laboratory: 2 years (required)
Work Location: In person
