Quality Assurance Associate

**About the Company**:
The Centre for Probe Development and Commercialization **(CPDC) **is a global leader of next-generation radiopharmaceuticals. At CPDC we are working with our partners to discover, develop and distribute the next generation of imaging agents and targeted radiotherapeutics for the detection and treatment of human diseases such as cancer.

Our Centre has the full range of scientific, technical, regulatory and business expertise combined with specialized infrastructure required to translate radiopharmaceuticals from clinics to the commercial marketplace. CPDC's success in the radiopharmaceutical industry results in the ability of our talented staff to develop reproducible processes that yield high quality products while adhering to international regulations governing nuclear safety, transportation of goods, and pharmaceutical manufacturing. Our staff takes pride in the impact we make every day in the lives of patients across the globe.

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Location: Toronto*

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About the role: *
The **Quality Assurance Associate** helps to ensure GMP compliance during validation activities and routine production of radiopharmaceuticals. This position will act as an interface between quality, radiopharmaceutical development, regulatory and production to ensure that all regulated activities listed below are conducted in compliance with relevant regulations and internal procedures.

**Responsibilities**:

- Participate in Batch Record Review to release marketed and clinical products for use, as well as retrospective Batch Record Close-out
- Involved in raw material and packaging component review and release
- Manage the QMS documentation system including issue all control documents and maintain the master documentation lists.
- Oversee the training program onsite including issue, monitoring and tracking all trainings.
- Review and approval of specifications for incoming raw materials and for finished products
- Review standard operating procedures (SOPs), Master Batch Records, Standard Test Methods and other controlled documents for compliance with regulations and propose changes for review and approval
- Support maintenance and improvement of the Quality Systems
- Represent Quality Assurance on project teams
- Develop and maintain an in-depth knowledge of key regulations and guidance documents, pertinent to Product Development and Quality and use this knowledge to improve the quality system; participate in building the CPDC Quality System according to Health Canada and FDA regulations, ICH Q10 and ISO guidance
- Complete any other related duties that support the core activities and mission of the Centre, as required

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Education/Skills Required: *

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A B.Sc or M.Sc in the life sciences degree; including pharmacy, chemistry or other equivalent qualification if preferred.
- 2-5 years of experience in a GMP or equivalent regulated environment
- Training and experience in documentation control, change control, CAPAs and review of quality records
- Understanding of Health Canada, FDA and EU GMP regulations, with specific knowledge of the regulations as they pertain to sterile products perferred
- Proficiency in the English language both written and oral and excellent communication skills; detail-oriented
- Ability to work independently and possess excellent organizational skills

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CPDC offers: *

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Competitive compensation
- Medical and dental benefits, sick days & more
- Opportunity for long-term growth
- Professional & collaborative environment with experienced individuals in the field
- Join a passionate team making a difference in patients lives and Canadian healthcare