Quality Assurance Analyst

6 days ago

Arnprior, Canada Pillar5 Pharma Inc. Full time

Reporting to the Microbiology Team Leader, the role of the Quality Assurance Analyst (Microbiology) is to prepare and perform microbial analysis on raw materials, finished products, blends, bulk products and stability samples as per the procedure and according to specified timelines.

RESPONSIBILITIES:

- Execute and independently perform routine analysis: Microbial Enumeration Test, Membrane Filtration (water system and bioburden), Microbial Identification, AET, Antibiotic Assay (Cylinder-Plate and Turbidimetric), Growth Promotion and Media Properties Test, Total Viable Spore Count and Colorimetric Assays.
- Recording, analyze, and interpret environmental monitoring results from the aseptic processing area and the non
- aseptic processing areas.
- Preparing and evaluate microbiological media, standards, controls, and rinse solutions.
- Preparing and maintenance of frozen stock cultures.
- Preparation of sterility test samples.
- Water sampling and environmental monitoring of the NAPA.
- Perform gown qualification training for the Aseptic Processing Area personnel and support personnel.
- Maintenance of laboratory equipment, housekeeping, dishes, and inspection readiness.
- Assist in laboratory failure investigations.
- Experience in computer programs (Word, Excel, and LIMS)
- Maintain records and notebooks in good order. Prepare reports and record data in timely manner.

QUALIFICATIONS AND REQUIREMENTS:

- B. Sc. in Microbiology (4 year) with related experience in a pharmaceutical manufacturing environment. Other combinations of technical training and experience may be considered.
- Minimum of 1-3 years of relevant laboratory work experience required.
- Able to work well under pressure and balance conflicting demands of high volume versus the quality of results.
- Sound knowledge of Microbiology test methods (USP) and aseptic techniques.
- Knowledge of gowning and aseptic practices in Aseptic Processing Areas.
- Knowledge of Six Sigma tools would be an asset.
- Knowledge of Biosafety practices and tools in a containment level 2 laboratory.
- Ability to calculate and perform serial dilutions.
- Demonstrated ability to work independently and within a team environment.
- Demonstrated planning, organizational, and time management skills.
- Experience in routine maintenance and operation of autoclaves, biological safety cabinets, centrifuges, microscope, pH meters, plate readers and automatic pipettors.
- Demonstrate excellent documentation practices and maintenance of records.
- Excellent oral and written communication skills.
- Experience and knowledge of computerized information systems (LIMS).
- Understanding of Good Laboratory Practices, Good Manufacturing Practices and the Canadian Biosafety

**What Pillar5 Pharma has to offer full-time permanent employees**:

- Starting at 3 weeks vacation.
- Stat Holidays plus 2 paid floater days.
- 2 paid personal days.
- Employer sponsored retirement plan.
- Full benefits including 80% employer paid medical and dental benefits.
- Early finish on Fridays.
- Clean, sterile, and safe work environment.
- Opportunities for advancement

**Job Types**: Full-time, Permanent

**Salary**: From $20.00 per hour

**Benefits**:

- Dental care
- Extended health care
- Paid time off
- RRSP match
- Vision care

Schedule:

- Day shift
- Monday to Friday
- Night shift

Ability to commute/relocate:

- Arnprior, ON: reliably commute or plan to relocate before starting work (required)

**Education**:

- Bachelor's Degree (preferred)

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