QA Specialist

2 weeks ago

Mississauga, Canada Candoo Pharmatech Company Inc Full time

**Company Overview**: Candoo Pharmatech Company Inc., headquartered in Mississauga, Canada, is a formulation-driven, customer-centric leader in advancing drug delivery solutions for small and large molecules. Our commitment to excellence drives us to create groundbreaking therapies that improve patients’ lives worldwide. As a trusted contract development and manufacturing organization (CDMO), we provide experienced, flexible, and cost-effective services with a short turnaround time, accelerating molecules to market for global pharmaceutical, biotech, and life sciences industries.

**Position: QA Specialist (Production)**

**Location**: Mississauga, Canada

**Role Overview**: Are you passionate about ensuring product quality and compliance in pharmaceutical manufacturing? As our QA Specialist (Production), you’ll play a pivotal role in maintaining the highest standards of quality throughout our production processes. Your attention to detail and commitment to following procedures will be critical in ensuring that our products meet regulatory requirements.

**Responsibilities**:

- **Quality Assurance in Production**:

- Act as the QA representative on shift, making informed decisions and resolving issues promptly.
- Verify in-process checks during production and review associated documentation.
- Perform line clearances and equipment verifications during product changeovers, including collecting samples for cleaning verification.
- **Finished Product Inspection**:

- Conduct Acceptable Quality Level (AQL) inspections on finished products to ensure compliance with cGMPs (Current Good Manufacturing Practices) and SOPs (Standard Operating Procedures).
- **Sample Collection and Analysis**:

- Collect samples for incoming materials according to the sampling plan and send them to the lab for testing.
- Use aseptic techniques to collect samples for microbiology analysis.
- Routinely collect purified water samples for testing and trend analysis.
- Collect environmental monitoring samples as scheduled, interpret testing results, and conduct trend analysis.
- **Documentation and Compliance**:

- Assist with deviations and investigations related to quality incidents.
- Participate in Change Controls and contribute to SOP review and revisions.
- Ensure proper archival of GMP records.
- **Internal Audits**:

- Participate in internal company audits to assess compliance and identify areas for improvement.
- **Other QA Duties**:

- Be adaptable and ready to take on additional QA responsibilities as assigned.

**Qualifications**:

- Previous work experience in quality assurance and/or production within a pharmaceutical manufacturing facility.
- Strong knowledge of Good Manufacturing Practices (GMP).
- Exceptional attention to detail and the ability to read, analyze, and interpret technical procedures.
- Minimum Bachelor of Science degree in chemistry; a Certificate in Quality Assurance would be an asset.

Expected hours: No less than 40 per week

**Benefits**:

- Company pension
- Dental care
- Employee assistance program
- Extended health care
- On-site parking
- Paid time off
- RRSP match
- Vision care

Flexible language requirement:

- French not required

Schedule:

- 8 hour shift
- Day shift
- Evening shift
- Monday to Friday
- Weekends as needed

Ability to commute/relocate:

- Mississauga, ON L5N 5L9: reliably commute or plan to relocate before starting work (preferred)

**Experience**:

- pharmaceutical QA: 3 years (preferred)

Work Location: In person

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