Quality Assurance Specialist

1 week ago

remote Remote Remote Canada fulltime November Medexus Pharma Careers Full time
Company Bio Medexus Pharma is a leading specialty pharmaceutical company with a focus on the therapeutic areas of rheumatology, auto-immune disease, specialty oncology, allergy, and pediatric diseases. We provide market-leading prescription and over-the-counter brands to patients and healthcare professionals, which we believe greatly enhances quality of life and promotes a healthy lifestyle. We have a strong North American commercial platform, and we currently operate through two unique segments: Medexus Pharma Canada and Medexus Pharma USA. Innovation is a driving force for our company. As a result, we are continuously licensing and/or acquiring new products and solutions aimed at addressing the essential needs of consumers, patients, and healthcare partners.   Role Overview The Quality Assurance Specialist supports QA activities related to contract manufacturing (CMO) and third-party logistics (3PL) operations for Medexus products distributed in Canada. This position performs routine QA documentation review, including batch record review, product release, change controls, deviations, product complaints, CAPA, Annual Product Quality Reviews (APQR), Quality System Management Review (QSMR), process qualifications and risk assessments. The Specialist ensures all activities are conducted in accordance with the appropriate regulatory requirements (Health Canada GMP and GDP), supports internal and external audit preparation, and assists with continuous improvement initiatives within the QA function. This position will primarily support Canadian products but will be able to provide back up support to the other country as needed.
Key Responsibilities
  • Provide QA oversight of contract manufacturers and third-party logistics partners, including batch record review, product release, deviation and change control documentation.
  • Review and support investigations of quality events (deviations, CAPAs, product complaints, product returns) to ensure compliance with Health Canada requirements.
  • Coordinate documentation and quality data exchange with CMOs and 3PLs, including shipment verification, temperature excursions, and product traceability.
  • Support compliance activities, ensuring accuracy of product and shipment data.
  • Assist with preparation and documentation for internal and external audits and inspections to ensure readiness.
  • Contribute to annual product quality reviews, quality system management review, yearly stability review, data trending, and analysis of quality metrics to identify improvement opportunities.
  • Maintain QA documentation, systems, and records to ensure data integrity and inspection readiness.
  • Participate in process improvement and risk assessment activities, including review of validation or qualification data.
  • Ensure QA procedures and work instructions remain current and aligned with company and regulatory standards.

Education, Experience, and Skill Requirements
  • Bachelor's degree in a scientific or technical discipline is preferred, or equivalent combination of education and experience.
  • 4+ years of experience in a Quality Assurance role within the pharmaceutical or biotechnology industry.
  • Experience with batch record review, document control, product release and complaint handling.
  • Experience with Health Canada GMP and GDP regulations.
  • Experience supporting QA oversight of contract manufacturing or distribution partners considered an asset.
  • Understanding of quality and compliance principles in a regulated environment.
  • Excellent attention to detail and accuracy in documentation review.
  • Excellent organizational and record-keeping skills.

Additional Information: ·       Compensation range: $60K-90K CAD ·       Travel or other requirements: Remote position with 10-15% travel for team and company meetings   We recognize that experience comes in many forms. Even if your background or compensation expectations don't exactly align with all the qualifications or compensation range listed, we encourage you to apply. Your unique skills and experience may be a great fit for this role or other opportunities at Medexus.   Medexus Pharma is an equal employment opportunity employer. We adhere to a policy of making employment decisions without regard to race, color, religion, sex, sexual orientation, national origin, citizenship, age, disability or any other characteristic protected by law. We assure you that your opportunity for employment with Medexus Pharma depends solely on your qualifications.

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