Quality Assurance Specialist II - Ottawa, ON

PanTHERA CryoSolutions, now a part of BioLife Solutions, designs and manufactures cryopreservation solutions for cells, tissues and organs. We are now recruiting for an exciting position in our Quality Assurance team and welcome you to apply to join our team! Here you will find a performance-based, family-oriented environment where authentic communication and treating colleagues with respect are required.

BioLife Solutions is a leading developer, manufacturer and supplier of class-defining cell and gene therapy bioproduction tools and services. Our solutions facilitate basic and applied research and commercialization of new therapies by maintaining the health of biologic source material and finished products during manufacturing, storage, and distribution. Our solutions offer commercial companies and clinical researchers significant improvement in shelf life and post-preservation viability and function of biologic materials. Our tools portfolio includes our proprietary, serum-free and protein-free, fully defined CryoStor freeze media and HypoThermosol shipping and storage media, ThawSTAR family of automated, water-free thawing products, and evo cold chain management system. For more information, please visit: www.biolifesolutions.com

General Summary And Purpose

The Quality Assurance Specialist II is a key team member of PanTHERA’s Quality Team. The Quality Assurance Specialist manages and maintains the QMS and supports the development and validation of quality compliant processes.

Duties And Responsibilities

• Provides support to the Quality Control and Manufacturing team in terms of developing and validating quality compliant processes.
• Monitor Quality Assurance practices to ensure appropriate and effective implementation of QMS throughout the company
• Draft, edit and maintain appropriate Quality Assurance records
• Revise and create new standard operating procedures (SOP’s)
• Responsible for document control record management
• Responsible for maintaining the company’s Corrective Action and Preventive Action (CAPA) system
• Ensure the compliance of procedures and policies in alignment with Good Manufacturing Practices (GMP)
• Review manufacturing and release testing records for release
• Responsible for reviewing raw materials records for release
• Responsible for managing supplier/vendor quality
• Responsible for conducting out-of-spec investigations
• Ensure quality assurance deliverables are met on time
• Hosts, participates, supports, conducts and, when required, leads audits to ensure compliance to all required regulatory agencies as well as company policies
  
  

Other Duties

• Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.
  
  

Job Requirements

• BSc degree in relevant discipline required
• Good understanding of GMP, USP and ICH guidelines is required
• 2+ years of relevant experience developing, running and/or participating in quality assurance programs is required.
• Prior experience in the pharmaceutical or biotechnology industry is required
• Experience writing and revising controlled documents is required
• Effective written and oral communication skills
• Focused team-oriented player with strong with ethic
• Enthusiasm to tackle difficult problems, learn new technologies, and work in an exciting, high paced environment is a must