Quality Assurance Associate- 12 Month-Term Windsor, NS, Canada Req #1697 Sunday, January 5, 2025

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.

At BIOVECTRA, we are passionate about improving patient care by making better therapeutics as a contract drug manufacturing organization (CDMO) that supports the top pharmaceutical and biotech companies in the world. Be part of a team with a global reach that also has a great community vibe. We care about each other and live our values of teamwork, respect, professionalism, and quality. Diversity is one of our strengths as we strive to offer a welcoming and inclusive environment.

BIOVECTRA has an opening for a Quality Assurance Associate. This is a 12 Month-term position based out of our Windsor, Nova Scotia facility.

The candidate will be responsible for:

• Supporting the incident programs (deviation, laboratory investigation, complaint, supplier etc), including reviewing, assessing the severity and approving minor incidents and outcomes of Phase 1 OOS investigations and participating in the investigations of major incidents.
• Participating in the internal audit program and supporting external audit requirements.
• Managing and leading changes to SOPs and supporting changes to SOPs made by other departments through the change control review process.
• Supporting the APR Program, Metrics and Scorecards Reporting Program, including QSR.
• Monitoring and enforcement of GMP requirements during day-to-day operations for all departments within the company.
• Supporting the supplier management program.
• Inspecting and releasing rooms and performing facility inspections as part of general compliance activities.
• Preparing or assisting in the preparation of reports and protocols, including validation and qualification.
• Issuing, checking, and archiving QC notebooks.
• Providing GMP and SOP training to various departments.
• Managing product label masters and creation.
• Supporting the CAPA program.
• Supporting Analytical validation and process transfer activities, and the overall method and Analytical process lifecycle by reviewing and approving analytical validation data and revising, reviewing and approving protocols, reports and work instructions as needed.
• Participating in the Pest Control program, including inspection and investigation.
• Performing batch record review and data review for release of critical raw materials, active pharmaceutical ingredients, and final products.
• Supporting Process lifecycle by reviewing and approving creation and changes to batch records.
• Participating in document lifecycle activities of SOPs, and QA review and approval of SOP changes.
• Additional duties assigned, based on business needs and the department supervisor's request.

The successful candidate for this position should have:

• Post-Secondary Education.
• Bachelor's degree in a scientific field an asset.
• Three years of work experience with a food or drug manufacturing company, with One-year direct experience in a Quality Unit position.

Note: Employees are eligible to apply for internal positions once they have completed a minimum of one year of service.

BIOVECTRA offers a competitive salary and benefit package. Interested candidates are asked to apply by choosing the "Apply Now" button.

Closing Date: January 20, 2025

Individual accommodations due to a disability are available upon request for candidates taking part in all aspects of the selection process. All qualified applicants will receive consideration for employment without regard to age, race, religion, ethnicity, gender, disability, citizenship status, marital status, actual or perceived sexual orientation. BIOVECTRA is committed to creating an inclusive environment and building a team that represents a variety of backgrounds, perspectives, and skills. We value diversity and recognize that experience comes in many forms and skills are transferable. Please view this description as a general overview, but not a mandatory comprehensive list. If you feel passionate about our efforts and believe that you have the skills to contribute and lead in this role, apply! We thank all interested parties; however, only those applicants considered for an interview will be contacted.

• Pay Type Salary