Medical Device Quality System jobs

Join one of Canada’s largest, fastest growing suppliers of control label products. CRL Synergy is seeking a Quality Assurance (QA) Specialist who can thrive in a fast-paced environment that involves working in an office team environment. Providing quality products to the consumer is paramount to the business.

The QA Specialist will be responsible for the pharmacovigilance program at CRLS including all complaint assessments, follow-up with the customer and supplier, as well as communication with Health Canada, as required. In addition, the role will include performing post market surveillance activities required for a compliant pharmacovigilance program.

This role will also provide quality assurance support through maintenance of the quality management system, verify SOPs are current and implemented, perform data collection, and subsequent analysis. The successful candidate will provide support for new product development and perform inspections of manufacturing records and labelling for new product release.

Responsibilities include:

• Review and assess customer complaints for adverse event and incident reporting, perform surveillance for ongoing product quality and safety.
• Ensure complaints, deviations, non-conformances, investigations, corrective, and preventative actions, and change control are completed according to quality and regulatory requirements.
• Assisting in updating methods and procedures (SOPs) related to the Quality Management System with a focus on the customer complaint and pharmacovigilance program.

· Conduct audits and inspections of pharmacovigilance processes to ensure compliance with regulatory standards and internal policies.

· Collaborate with cross-functional teams to implement corrective and preventive actions (CAPA) related to post-market surveillance findings.

· Participate in risk management activities and contribute to the development of risk assessment strategies.

• Ensuring accurate record keeping and filing as per organizational procedures.
• Handle clerical and administrative activities.

Specific skill requirements:

• Bachelor’s degree in Life Sciences, Pharmacy, or related field from a Canadian institution is required.
• Minimum of 1 year of experience related to post market surveillance and pharmacovigilance is an asset.
• Excellent time management skills and ability to multi-task efficiently and prioritize work.
• Attention to detail and processes.
• Excellent written and verbal communication skills.
• Strong organizational, planning and problem-solving skills.
• Efficient with computers and computer programs; proficient in MS Office suite of products.
• Proven track record of success in a high-pressure, fast-paced environment with changing multiple priorities and frequent interruptions.
• Able to work individually or as part of a team.
• Customer focused.
• Knowledge of good manufacturing practices and experience in GMP environment is an asset.
• Regulatory Affairs experience with cosmetics, natural health products, OTC drugs or medical devices an asset.

Job Types: Full-time, Permanent

Schedule:

• Monday to Friday

Education:

• Bachelor's Degree (required)

Experience:

• Quality Assurance: 2 years (required)
• Pharmacovigilance: 1 year (preferred)

Work Location:

· In person

Job Types: Full-time, Permanent

Pay: $65,000.00-$95,000.00 per year

Benefits:

• Dental care
• Extended health care
• On-site gym
• On-site parking
• Tuition reimbursement
• Vision care

Education:

• Bachelor's Degree (required)

Experience:

• quality assurance: 1 year (required)

Work Location: In person