Quality Assurance Specialist

5 days ago

Brockville, Canada Trillium Health Care Products Inc. Full time

**Basic Function**

To ensure that all products manufactured and/or packaged at Trillium are safe, pure, and effective, and that they comply with established quality standards and specifications according to current Good Manufacturing Practices guidelines.

**Responsibilities**
- Review manufacturing and packaging batch records to ensure accuracy and completeness for each lot of product processed.
- Review raw material and packaging component documentation and approve/reject receipts as required.
- Review in-process and finished product samples to determine product quality and lot acceptability.
- Ensure deficiencies and discrepancies are completed and reconciled as required prior to product release or disposition. Recommend appropriate corrective actions and follow-up as required.
- Approve/reject drug products as required. Complete required documentation and inventory status change.
- Complete internal or customer documentation requirements including Certificate of Analysis, Certificate of Conformance and other relevant information.
- Assist in internal (self-inspection) quality audits and other investigations as required to improve quality and compliance levels.
- Perform a systematic investigation of quality defect customer complaints for approved marketed products manufactured and/or packaged within the SOLABS EQMS system.
- Maintain internal complaint and rejection database.
- Review and approve calibration data using calibration software program.
- Monitor performance of temperature/humidity monitoring equipment.
- Lead, participate in, and/or review root cause investigations and proposed CAPA for deviation reports.
- Assess and document potential or known impact to quality of raw materials, packaging components, and/or finished goods product. Prepare risk assessments.
- Ensure Deviations are closed in timely manner.
- Inform customers of deviation reports as they are initiated and maintain communication with customer QA while investigations are in process.
- Administration of the Deviation Report tracking database and electronic and hard copy event reports.
- Back-up for review and approval of protocols related to AQLs, inspection, rework, reprocessing, repackaging, and other activities.
- Act as designate for Manufacturing Quality Assurance Supervisor.
- Draft monthly Quality Metrics related to right-the-first-time, finished product rejections, past due/aging Notices of Event, and AQL/rework/reprocessing/ repackaging/inspection activities.
- Other duties as assigned.

**Qualifications**
- Minimum 3 years’ experience in a Quality Assurance Role with GMP.
- Minimum Bachelor of Science Degree in a related science
- Demonstrated problem solving skills
- Demonstrated technical writing skills

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

**Benefits**:

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

Schedule:

- 8 hour shift
- Day shift
- Evenings
- Monday to Friday
- Night shift

Ability to commute/relocate:

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

**Education**:

- Bachelor's Degree (preferred)

**Experience**:

- quality assurance with GMP: 3 years (required)

Work Location: One location

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