Biological sciences Jobs in Cambridge, ON

Job Summary

The Quality Assurance Project Associate is accountable to the Senior Director, Quality. This role assists with Pharma client‑related quality activities, documentation creation and revision, and performs batch record review and product release primarily for Pharma products in development. The QA Project Associate may perform final release of commercial batches exercising independent judgment for verifying compliance and authorizing release during peak manufacturing times.

The QA Project Associate provides administrative and technical support to the QA project team, helping ensure that quality requirements are met, timely client notifications are sent, and internal and external timelines are adhered to. This role will support Pharma client regulatory filings through the preparation of documentation for clients and regulatory agencies as part of client product submissions.

Responsibilities

• Maintains and creates client‑specific quality documentation, including quality plans, failure modes and effects analyses (FMEA), and medical device records, as well as tracking commitments, organizing correspondence, and creating and maintaining project files.
• Provides administrative support to the QA project team during new product introductions, technical transfers, and ongoing client projects.
• Communicates regularly with Pharma clients through the preparation and sending of client notifications for quality events (e.g., deviations, investigations, change controls). Coordinates routine and ad‑hoc quality discussions with clients, providing status updates, clarifying requirements, and ensuring that client questions are addressed promptly and accurately Discussions require sound judgement and professional discretion that uphold regulatory expectations and protect product quality.
• Participates in client meetings as the QA representative. Relays information to QA leadership including client escalations or leadership input, direction and/or decision making.
• Tracks client acknowledgments, responses, and follow‑up actions to ensure timely closure and proper documentation. Tracks notification timing for compliance reporting to QA leadership; escalates deviations based on contractual requirements.
• Supports client regulatory filing activities by obtaining and preparing documentation required for related filings. Sends documentation (with relevant redactions) to clients and/or direct to regulatory agencies as part of client product submissions.
• Reviews and releases development pharma batches, determining batch status, e.g., release, reject, or product hold for further clarification or investigation. Serves as the decision-making authority, bearing accountability and responsibility for verifying compliance and authorizing release.
• Reviews and releases commercial pharma batches during peak manufacturing times as required, determining batch status, e.g., release, reject, or product hold for further clarification or investigation. Assesses potential impact of incidents and processing deviations on the quality and suitability of the product for release to clients. Serves as the decision-making authority, bearing accountability and responsibility for verifying compliance and authorizing release.
• Tracks quality deliverables and timelines, ensuring documents are routed, reviewed, and approved on schedule to meet project timelines. Drives completion of quality documentation through routine follow-up and communication with internal stakeholders and external clients.
• Assists in compiling quality metrics, reports, and project summaries for internal and client use.
• Identifies opportunities to streamline documentation workflows and improve the efficiency of QA project processes.
• Participates in departmental initiatives aimed at strengthening quality compliance and operational consistency.
• Coordinates meetings, prepares agendas, and documents minutes.

Qualifications

Education

• B.Sc. from an accredited University in Life Sciences (Microbiology, Chemistry, Biology etc.)

Experience

• Minimum of three (3) years’ practical experience in a Quality function or a senior role within Operations or Project Management with detailed knowledge of quality compliance.
• Experience in a pharmaceutical manufacturing environment would be an asset (cGMP).
• Demonstrated ability to assess and process incidents, evaluate impacts on product quality and patient safety, and support independent release/reject/hold decisions.
• Previous experience coordinating meeting logistics, agendas, meeting minutes and follow-up actions.
• Ability to work independently with minimal supervision, while collaborating with cross-functional teams.
• High attention to detail and documentation accuracy.
• Strong organization and coordination skills, and the ability to manage multiple priorities in a fast-paced environment.
• Excellent verbal and written communication skills.
• Strong problem solving and decision-making skills.
• Commitment to regulatory compliance, product quality, and patient safety.

What we Offer:

• Excellent compensation/benefits package
• RRSP Program
• Discounted gym memberships
• Programs supporting work life balance (EAP)
• Corporate Discounts and PERKS
• Employee recognition program
• Social events and spirit days

Compensation

Starting at approximately $84,000.00 CAD with opportunity for increase based on qualifications and experience. Total rewards include comprehensive benefits, bonus eligibility, and professional development support.

We are committed to diversity and inclusion and thank all applicants in advance; however, we will be corresponding only with those selected for an interview. Candidates interviewed will receive (notification of) a decision within 45 days.

In accordance with the Ontario Human Rights Code and the Accessibility for Ontarians with Disabilities Act, we are committed to providing an inclusive and barrier free recruitment and selection process.

Contract type

Permanent

Position location