QA Data Reviewer

5 days ago


Brockville, Canada Trillium Health Care Products Inc. Full time

**PRIMARY RESPONSIBILITY**

Provides data review and support as described below to laboratory functions. Includes meeting scheduled attainment by prioritizing, reviewing and approving test data, and meeting GMP requirements for documentation and records.

**SPECIFIC DUTIES**
- Check test reports, logbooks and raw data from laboratory staff for accuracy, validity and completeness and approve as required to meet schedules. This includes but is not limited to finished product, stability, raw materials, validation data review, verification calibration review, solution /standard preparation review, method transfer data review, validation data review and, review of data resulting from executing on investigations.
- Review function may be hard copy (paper) review or online (electronic) review.
- Perform electronic audit trail review for the QC laboratory instruments.
- Perform review/approvals of CALS updates when changes are made to specification (AWC and PKGAWC) May be required to initiate, lead and/or execute Change Controls, CAPA’s and NOE’s related to lab investigations, and GMP compliance.
- Provide mentorship for QC laboratory analysts to create a culture of continuous improvement.
- Provide support for self-inspection activities.
- Provide support as back up for management of retain samples for raw materials and finished product.
- Other duties as required or assigned.

**EDUCATION/EXPERIENCE**
- Previous related QA/QC work experience.
- Attention to detail is critical to this job function.
- Experience in Chromatography is considered a valuable asset to this role
- Experience with USP (United States Pharmacopeia) and navigating the USP is considered an asset.
- Ability to perform in a fast paced environment with a minimum of supervision.
- In addition excellent interpersonal, communication, organizational and computer skills are required.
- Post-secondary education in science, BSc or equivalent university degree.

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

**Salary**: From $65,000.00 per year

**Benefits**:

- Company pension
- Dental care
- Employee assistance program
- Extended health care
- Life insurance
- Profit sharing

Schedule:

- 12 hour shift
- 8 hour shift
- Monday to Friday
- Weekend availability

Supplemental pay types:

- Overtime pay

Ability to commute/relocate:

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

**Experience**:

- Quality Control/Quality Assurance: 1 year (preferred)
- United States Pharmacopeia: 1 year (preferred)

Work Location: One location


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