06 Sep
|
Trillium Health Care Products
|
Brockville
06 Sep
Trillium Health Care Products
Brockville
*Note: This posting is for an existing vacancy for internal and external applicants.
Overview
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.
Duties
- 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.
Experience
- 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
Equal Opportunity Employer
Trillium Health Care Products is an equal opportunity employer. We are committed to creating an inclusive setting for all employees and applicants. We believe in the value of diverse perspectives and experiences and strive to provide a workplace where everyone feels respected and valued. If you require accommodations throughout the recruitment process, please let us know and we will work with you to meet your needs.
AI-Assisted Recruitment
At Trillium Health Care Products, we leverage standard AI technology to enhance our recruitment process. Our AI-assisted tools help us identify the best candidates efficiently and fairly, ensuring a streamlined and unbiased selection process.
Job Types: Full-time, Permanent
Pay: From $30.00 per hour
Benefits:
- Casual dress
- Company events
- Company pension
- Disability insurance
- Employee assistance program
- Extended health care
- Life insurance
- On-site parking
- Paid time off
- Wellness program
Application question(s):
- Have you ever been convicted of a criminal offence, for which you have not received a pardon?
Education:
- Bachelor's Degree (required)
Experience:
- quality assurance: 3 years (required)
Work Location: In person
📌 QA Specialist (Brockville)
🏢 Trillium Health Care Products
📍 Brockville