Quality Assurance Associate Systems

AtomVie Global Radiopharma•Hamilton, ON

9d•CA$0 - CA$60,000•Onsite

About The Position

The Quality Assurance Associate Systems helps to ensure GMP compliance for production of new and ongoing radiopharmaceuticals at AtomVie. 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.

Requirements

Post-Secondary Education in Engineering, Chemistry, Microbiology or a related field
3 to 5 years of relevant experience
Experience working in a GMP environment is required
Training and experience in quality systems, quality audits, good documentation practices, change controls, 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 skills
Strong client-facing and teamwork skills

Nice To Haves

Experience preparing/reviewing quality documentation is an asset

Responsibilities

Through on-going monitoring and review, ensures that the quality systems are in compliance with regulatory requirements and meet the needs of the AtomVie and its clients
Works collaboratively with stakeholders to ensure the systems are kept current and are effective with current applicable regulations
Manage and Track non-conformances, laboratory investigations, CAPAs, change controls, and complaint system.
Lead job board and change control committee meetings with the internal stake holders.
Prepare quality performance metrics and provides monthly report to Quality Assurance Management
Participates and leads internal audits, including scheduling, conducting and preparing reports.
Participates in on-site audits by regulatory authorities and clients, including preparation and follow-up activities
Perform compliance review of aseptic process and operator qualification media fills and equipment Qualification/Calibration records.
Performs compliance review of equipment PM and calibration records.
Participates and leads GMP training program for the new employees or as required.
Meet on a regular basis with the Manager QA Systems to provide updates on ongoing activities, track and set priorities, and address issues and problems
Acquire an appropriate understanding of quality processes, developing approaches to achieve compliance that ensure relevant standards are being met.
Support document management system activities
Serve as a primary contact with minimal supervision for QA activities associated with introduction of new QA requirements; these include review of non-conformance, preparation and close-out of CAPAs and change controls, as required.
Assist on project deliverables to ensure that high quality standards are met and are compliant with internal/external requirements and GMP regulations.
Provide guidance and support to QA staff, ensuring the QA system and areas are maintained to AtomVie standards and regulatory requirements, mentoring and coaching these staff members to understand the importance and implications Quality has at AtomVie.
Ensure compliance with Health and Safety for all policies, procedures and regulations applicable to their work.
Other duties as assigned