Quality Assurance Floor Associates

5 days ago

Charlottetown, Canada BioVectra Inc. Full time

BIOVECTRA Inc. is a leading bio-science business in Prince Edward Island and Nova Scotia, focused on contract manufacturing and product development of active pharmaceutical ingredients, pharmaceutical intermediates, and bioreagents.

**BIOVECTRA **has openings for **Quality Assurance Floor Associates. **These are permanent, full-time positions located in **Charlottetown, PEI.**
- Provide consultation or advice in alignment with QA policies through on the floor presence, working with other departments by providing QA guidance to events or questions that may arise.
- Supporting the incident programs (deviation, laboratory investigation, CAPA, etc.), including reviewing, assessing the severity, and approving minor incidents and outcomes of Phase 1 OOS investigations.
- Escalation of major incidents (manufacturing and quality control) to Senior Quality Management. Participating in the investigations of major incidents.
- Participating in the internal audit program and supporting external audit requirements.
- Monitoring and enforcement of GMP requirements during day-to-day operations for all departments within the company.
- Issuance of batch production records to the Manufacturing Department.
- Issuance of batch specific finished product labels.
- Inspecting and releasing rooms and performing facility inspections as part of general compliance activities.
- Issuing, checking, and archiving QC notebooks.
- Supporting the manufacture of materials by conducting in-process quality inspections as required.
- Performing activities associated with disposition of product (e.g. GMP batch record review, GMP analytical data review, creation of batch specific certificate of conformance and certificate of origin, holistic review and closure of incidents).
- Performing computer system inspection for data integrity.
- Supporting Process lifecycle by reviewing and approving creation and changes to documents.
- Mentoring and training others with similar job duties as requested.
- Additional duties assigned, based on business needs and the department supervisor’s request.
- Post-Secondary Education.
- Bachelor’s degree in a scientific field an asset.
- 12 hour rotating shift (Days/Nights).
- Ability to work overtime, as requested.
- Must pass annual vision test and be free of color blindness.
- Work that includes periods of walking, extended periods of standing, and movement of the body such as kneeling and climbing.
- Working environment: fluorescent lights, chemical handling.

**The starting hourly rate is $22.00 per hour, and the offer will be based on skills and experience.**

**Closing Date September 27, 2024*

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