Quality Assurance Specialist II - Ottawa, ON

BioLife Solutions, Inc.; Ottawa; On-site; CAD 60,000 - 80,000; Full time

Job summary

A leading biotechnology company in Ottawa is seeking a Quality Assurance Specialist II to join their dynamic team. In this role, you will manage and maintain the Quality Management System (QMS) and support the development of quality processes. Ideal candidates should possess a BSc in a relevant field and at least 2 years of experience in the pharmaceutical or biotech industry. Strong communication skills and a team-oriented attitude are essential. This full-time position emphasizes a collaborative environment focused on quality assurance.

Qualifications

• BSc degree in a relevant discipline.
• Understanding of GMP, USP, and ICH guidelines.
• At least 2 years of experience in quality assurance programs.
• Experience in the pharmaceutical or biotech industry.
• Experience writing and revising controlled documents.
• Effective communication skills.
• Team-oriented with strong work ethic.
• Enthusiasm for problem-solving, learning new technologies, and working in a high-paced environment.

Responsibilities

• Support Quality Control and Manufacturing teams in developing and validating quality processes.
• Monitor QA practices to ensure effective implementation of QMS across the company.
• Draft, edit, and maintain QA records.
• Create and revise SOPs.
• Maintain the Corrective Action and Preventive Action (CAPA) system.
• Ensure procedures and policies comply with GMP standards.
• Review manufacturing and release testing records.
• Review raw material records for release.
• Conduct out-of-spec investigations.
• Ensure timely delivery of QA deliverables.
• Participate in, support, and lead audits to ensure compliance with regulatory agencies and company policies.

Job description

Quality Assurance Specialist II - Ottawa, ON

Join to apply for the Quality Assurance Specialist II role at BioLife Solutions, Inc.

PanTHERA CryoSolutions, now part of BioLife Solutions, designs and manufactures cryopreservation solutions for cells, tissues, and organs. We are recruiting for an exciting position in our Quality Assurance team and welcome your application! We offer a performance-based, family-oriented environment emphasizing authentic communication and respect among colleagues.

BioLife Solutions is a leading developer and supplier of cell and gene therapy bioproduction tools and services. Our solutions support research and commercialization of new therapies by maintaining biologic materials during manufacturing, storage, and distribution. Our portfolio includes CryoStor freeze media, HypoThermosol shipping media, ThawSTAR automated thawing products, and evo cold chain management system. For more information, visit www.biolifesolutions.com.

General Summary and Purpose

The Quality Assurance Specialist II is a key member of PanTHERA’s Quality Team, managing and maintaining the QMS and supporting the development and validation of quality processes.

Duties and Responsibilities

1. Support Quality Control and Manufacturing teams in developing and validating quality processes.
2. Monitor QA practices to ensure effective implementation of QMS across the company.
3. Draft, edit, and maintain QA records.
4. Create and revise SOPs.
5. Maintain the Corrective Action and Preventive Action (CAPA) system.
6. Ensure procedures and policies comply with GMP standards.
7. Review manufacturing and release testing records.
8. Review raw material records for release.
9. Conduct out-of-spec investigations.
10. Ensure timely delivery of QA deliverables.
11. Participate in, support, and lead audits to ensure compliance with regulatory agencies and company policies.

Other Duties

This job description is not exhaustive; duties may change as needed.

Job Requirements

• BSc degree in a relevant discipline.
• Understanding of GMP, USP, and ICH guidelines.
• At least 2 years of experience in quality assurance programs.
• Experience in the pharmaceutical or biotech industry.
• Experience writing and revising controlled documents.
• Effective communication skills.
• Team-oriented with strong work ethic.
• Enthusiasm for problem-solving, learning new technologies, and working in a high-paced environment.

Seniority level: Entry level

Employment type: Full-time

Job function: Quality Assurance

Industry: Biotechnology

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