Trillium Health Care Products Inc. Looking for QA Specialist at Brockville, ON 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.

· Minimum Bachelor of Science Degree in a related science

· Demonstrated problem solving skills

· Demonstrated technical writing skills

Job Types: Full-time, Permanent

Salary: From $65,000.00 per year

Ability to commute/relocate:

• Brockville, ON K6V 5W5: reliably commute or plan to relocate before starting work (required)

Education:

• Bachelor’s Degree (required)

Experience:

• related work: 3 years (required)