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QA Specialist

2 weeks ago

Mississauga, Canada Candoo Pharmatech Company Inc Full time

**QA Specialist (QC)**

**Location**: Mississauga, Ontario

**Job Type**: Full-Time

**About Candoo Pharmatech**

Candoo Pharmatech Inc. is a Canadian Contract Development and Manufacturing Organization (CDMO) based in Mississauga, Ontario. We specialize in formulation development, analytical testing, and GMP manufacturing of clinical trial materials for the pharmaceutical industry.

At Candoo, we are committed to quality, innovation, and scientific integrity. Our team is the foundation of our success, and we pride ourselves on fostering a collaborative, fast-paced, and quality-driven environment.

**Position Summary**

Candoo Pharmatech is seeking a detail-oriented and proactive **QA Specialist (QC)** to support our growing Quality & Compliance team. This role is focused on providing quality oversight of laboratory-based quality control activities, including review of analytical data, documentation, and compliance with GMP and data integrity standards.

**Key Responsibilities**
- Review QC laboratory documentation, including raw data, logbooks, analytical test results, and reports for compliance with GMP and internal SOPs.
- Evaluate analytical data from techniques such as HPLC, GC, FTIR, TOC, dissolution, and wet chemistry to ensure scientific validity and data integrity.
- Identify, document, and support the resolution of deviations, OOS, and OOT results.
- Participate in laboratory investigations, CAPAs, and change controls.
- Ensure Certificates of Analysis (CoAs) are accurate and issued in accordance with batch release requirements.
- Collaborate with QC analysts and QA colleagues to maintain compliance with regulatory and customer expectations.
- Assist in the development, review, and revision of GMP documents (e.g., SOPs, forms, protocols, reports).
- Support internal audits and regulatory inspections by preparing and maintaining QA records.
- Track and report quality metrics related to QC documentation and compliance performance.
- Provide input and support for continuous improvement initiatives within the QA/QC function.
- Ensure compliance with Health Canada, FDA, ICH, and applicable international regulations and guidelines.

**Qualifications & Requirements**
- **Work Eligibility**: Must be legally eligible to work in Canada (citizen or permanent resident).
- **Education**: B.Sc. in Chemistry, Pharmaceutical Sciences, or a related discipline.
- **Experience**: Minimum 3 years of QA experience in a GMP-regulated pharmaceutical or CDMO environment with exposure to QC operations.
- **Technical Expertise**:

- Solid understanding of analytical chemistry and laboratory instrumentation (HPLC, GC, LC/MS/MS, etc.).
- Familiarity with compendial methods (e.g., USP, EP, JP) and method validation principles.
- **Regulatory Knowledge**:

- Working knowledge of cGMP, GDP, ICH, FDA CFR Part 211, Health Canada regulations, and ALCOLA+ principles.
- **Skills**:

- Strong attention to detail, documentation accuracy, and analytical thinking.
- Excellent written and verbal communication skills.
- Proficient with Microsoft Office (Word, Excel, PowerPoint); experience with QMS or LIMS is an asset.
- Ability to work independently and in cross-functional teams in a dynamic environment.

**Why Join Candoo Pharmatech?**
- Opportunity to contribute to the development and manufacture of innovative clinical-stage therapies
- Collaborative, supportive workplace with strong emphasis on quality and learning
- Competitive compensation and benefits
- RRSP matching program
- Career development and training opportunities
- Exposure to a wide range of early-phase pharmaceutical technologies

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

Pay: From $55,000.00 per year

**Benefits**:

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

Schedule:

- 8 hour shift
- Monday to Friday

Work Location: In person