Quality Assurance Associate
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 Inc. has an opening for a Quality Assurance Associate. This is a permanent, full-time position located in Windsor, Nova Scotia.
The candidate will be responsible for:
- Reviewing and approving documents required to ensure the QC and Analytical department are in compliance with good laboratory procedures
- Reviewing and approving new and revised batch products records (BPRs) to ensure processes are in compliance with Good Manufacturing Practices (GMP)
- Performing facility evaluations as part of general compliance activities, and performing inspection and QA approval of manufacturing suites
- Preparing audit checklists and documenting audit findings in accordance with corporate procedures
- Performing review of cleaning validation and verification data to support process activities
- Completing analytical review of critical raw materials to confirm disposition prior to distribution for use
- Performing process and analytical data review for the final release approval or rejection of GMP products destined for pharmaceutical use
- Reviewing all process and quality events (deviations, OOS, and CAPA) associated with the release of a final product batch
- Providing technical assistance/reviews and approvals on equipment and process validations programs
- Assisting and preparing mock process inspections prior to FDA and Health Canada audits
- Participating in customer audits, including providing document support, discussion, and response to observations
- Collecting water samples from HP water systems and air/surface samples from rated processing suites to support our environmental monitoring program
- Remaining current with all applicable GMP, FDA, Health Canada regulations and ICH guidelines related to the manufacture, testing and distribution of BioVectra products
The successful candidate for this position should have:
- Bachelors of Science plus minimum 2 years of experience in a GMP environment
- Bachelors of Science in Biochemistry or Biology preferred
- Knowledge of Equipment and Controls Commissioning and Qualification
- Experience with Quality Assurance, Process & Cleaning Validation,
- Knowledge of cGMP, Health Canada regulations and FDA guidelines
- Good oral and written communication skills
- Ability to work independently with minimal supervision
BioVectra offers a competitive salary and benefit package. Interested candidates are asked to apply by choosing the “Apply Now” button below.
Closing Date: April 1st, 2020
We thank all applicants for their interest but wish to advise that only those selected for an interview will be contacted.
- Pay Type Salary
- Windsor, NS, Canada