Senior Quality Assurance Associate

Biovectra; Charlottetown; On-site; CAD 50,000 - 68,000; Full time

Benefits offered by this job

Competitive salary

Benefits package

Job summary

BIOVECTRA Inc. in Charlottetown, PEI, is seeking a Senior Quality Assurance Associate to lead a QA team and ensure GMP compliance across all departments.

The role emphasizes incident oversight, audits, SOP changes, CAPA, validation, and batch release activities in a regulated manufacturing environment. The successful candidate will bring a chemistry/biochemistry background, GMP/GLP experience, and strong communication skills, with a commitment to independent, collaborative work in a fast-paced

Qualifications

• Bachelor of Science degree in Chemistry or Biochemistry.
• Master of Science an asset.
• Five years of relevant work experience in a GMP or GLP environment.
• One year's direct experience in a Quality Unit position.
• Knowledge of cGMP, FDA, and Health Canada pharmaceutical regulations for APIs.
• Experience with Regulatory Agencies.
• Proficient communicator, both written and oral.
• Able to work independently with minimal supervision as well as part of a team.

Responsibilities

• Providing guidance and oversight to a team of employees.
• Supporting 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.

Skills

GMP/GLP knowledge

Regulatory agencies experience

Communication skills

Independent / self-directed work

Team collaboration

Education

Bachelor of Science in Chemistry or Biochemistry

Master of Science (asset)

Job description

BIOVECTRA Inc. has an opening for a Senior Quality Assurance Associate. This is a full-time permanent position located in Charlottetown, PEI.

The candidate will be responsible for:

• Providing guidance and oversight to a team of employees.


• 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.

The successful candidate for this position should have:

• Bachelor of Science degree in Chemistry or Biochemistry.


• Master of Science an asset.


• Five years of relevant work experience in a GMP or GLP environment.


• One year's direct experience in a Quality Unit position.


• Knowledge of cGMP, FDA, and Health Canada pharmaceutical regulations for API's.


• Experience with Regulatory Agencies


• Proficient communicator, both written and oral.


• Able to work independently with minimal supervision as well as part of a team.

BIOVECTRA offers a competitive salary and benefit package.

Entry: $58,968

Closing Date: July 13, 2025