Centre for Probe Development and Commercialization
  • Hamilton, ON, CAN
  • Full Time

Company Profile:

The Centre for Probe Development and Commercialization (CPDC) is dedicated to fostering the discovery, development and distribution of next-generation radiopharmaceuticals that are used daily for the detection and treatment of human diseases such as cancer.  CPDC offers career growth and development in a highly entrepreneurial environment.  CPDC offers medical and dental benefits, sick days and more.

The Senior Quality Assurance Associate is a focused and motivated individual who will oversee QA activities required to introduce new products at the CPDC.  This will involve interfacing with client and CPDC representatives to address all quality related matters.  The incumbent will ensure GMP compliance during validation activities and manage the subsequent transfer of quality tasks to team members responsible for supporting routine production.

This is a Full Time opportunity based in Hamilton, Ontario.

Reporting to the Director, Quality Assurance the responsibilities and job tasks include (but are not limited to):

  • Responsible for QA activities associated with validation and supply of CPDC products; these include review of non-conformance reporting and investigations, follow up with CAPAs and change control activities
  • Contribute to the development of tasks and timelines as they pertain to quality assurance requirements for assigned projects, working with members of the QA team to ensure deliverables are met according to plan
  • Represent CPDC as the key Quality contact with client QA departments to develop approaches to compliance and address any issues in a timely manner
  • Participate in client project team meetings to provide quality assurance updates and expertise as required
  • Acquire an appropriate understanding of manufacturing processes, developing approaches to achieve compliance that ensure relevant standards are being met.
  • Review standard operating procedures (SOPs), MBRs, STMs and other controlled documents for compliance with regulations and propose changes for review and approval
  • Review and approval of specifications for incoming raw materials and for finished products
  • Review validation and stability protocols for compliance
  • Review reports for compliance with protocols, quality system and regulatory requirements
  • Support validation  activities  including  review  of  executed  batch  records  and  testing  data for compliance, as well as reviewing OOS, non-conformances, Change Controls and CAPAs
  • Support maintenance and improvement of the Quality Systems, as needed
  • Participates in regulatory and client GMP inspections, as needed, and contributes to formal responses and CAPAs
  • Conducts relevant internal training of staff where needed
  • Updates job knowledge by studying trends in and developments in quality management; participating in educational opportunities; reading professional publications; maintaining personal networks; and participating in professional organizations
  • 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

Requirements:

  • Post-Secondary Education in Engineering, Chemistry, Microbiology or a related field
  • 3 to 5 years of relevant experience
  • Experience working in a GMP is required
  • Training and experience in quality systems, quality audits, documentation, change control, CAPAs and review of quality records
  • Strong understanding of Health Canada and FDA GMP regulations, with specific knowledge of the regulations as they pertain to sterile products
  • Proficiency in the English language both written and oral and excellent communication skills; detail-oriented
  • Ability to work independently and possess excellent organizational skill
  • Flexibility in work schedule to support a 24/7 production environment

If you require accommodation for your application or interview, please contact Human Resources directly at 905.525.9140 ext. 21112 or by email at careers@imagingprobes.ca

 

We thank all those who apply but only candidates selected for interviews will be contacted.

 

 

Full Job Description
Centre for Probe Development and Commercialization
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