Quality Assurance Associate

2 weeks ago

Hamilton, Canada Centre For Probe Development And Commercialization Full time

AtomVie is a global leading GMP manufacturer and distributer of clinical and commercial radiopharmaceuticals. We work with our partners to empower the next generation radiotherapeutics for the detection and treatment of cancer and human diseases.
**About the Role**
- Reporting to the Supervisor, Quality Assurance Operations, the
**Quality Assurance Associate **will help to ensure GMP compliance during 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.

**Location: Hamilton (On-site)**

**What You Will Do**
- QA activities associated with supply of AtomVie products; these include review of non-conformance reporting and investigations, follow up with CAPAs and change control.
- Participate in Batch Record Review to release marketed and clinical products for use, as well as retrospective Batch Record Close-out.
- 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.
- Review and approval of specifications for incoming raw materials and for finished products.
- Review stability protocols for compliance.
- Review reports for compliance with protocols, quality system and regulatory requirements.
- Support maintenance and improvement of the Quality Systems.
- Represent Quality Assurance on project teams.
- Provide support to internal and external audits by the AtomVie and participate in regulatory inspections of AtomVie facilities, as needed.
- Assist in drafting and finalizing Annual Product Quality Reviews.
- Develop and maintain an in-depth knowledge of key regulations and guidance documents, pertinent to Quality Assurance and use this knowledge to improve the quality system; participate in building the AtomVie Quality System according to Health Canada, EU and FDA regulations, ICH Q10 and ISO guidance.
- Other duties as assigned

**Skills & Experience Required**
- A B.Sc or M.Sc in the life sciences with 1-5 years of experience in a GMP or equivalent regulated environment
- Training and experience in quality systems, quality audits, documentation, change control, CAPAs and review of quality records
- Strong understanding of Health Canada, FDA and EU 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 with mínimal supervision
- Flexibility in work schedule to support a 24/7 production environment

**AtomVie Offers**:

- Group Health & Dental Benefits
- RRSP Matching
- Wellness Benefit
- Parking Reimbursement
- Training & Career Development
- Opportunity for long-term growth
- Join a passionate team making a difference in patients’ lives

  • Quality Assurance Associate

    1 week ago

    Hamilton, Canada Centre For Probe Development And Commercialization Full time

    AtomVie is a global leading GMP manufacturer and distributer of clinical and commercial radiopharmaceuticals. We work with our partners to empower the next generation radiotherapeutics for the detection and treatment of cancer and human diseases. **About the Role** - Reporting to the Supervisor, Quality Assurance Operations, the - **Quality Assurance...

  • Quality Assurance Associate

    1 week ago

    Hamilton, Canada AtomVie Global Radiopharma Inc. Full time

    AtomVie is a global leading GMP manufacturer and distributer of clinical and commercial radiopharmaceuticals. We work with our partners to empower the next generation radiotherapeutics for the detection and treatment of cancer and human diseases. **About the Role** Reporting to the Supervisor, Quality Assurance Operations, **the Quality Assurance Associate...

  • Quality Assurance Associate

    2 weeks ago

    Hamilton, Canada Emerson Full time

    The Quality Assurance Associate role is to assist the Quality Assurance Manager and to help provide quality oversight of all stages of the manufacturing process; providing guidance to production personnel to address quality issues and ensuring compliance with policies and procedures. The role includes interfacing with all employees in functional areas such...

  • Quality Assurance Associate- Batch Release

    3 weeks ago

    Hamilton, Canada AtomVie Global Radiopharma Inc. Full time

    Quality Assurance Associate- Batch ReleaseQuality Assurance Associate- Batch ReleaseGet AI-powered advice on this job and more exclusive features.AtomVie Global Radiopharma Inc. is a global leading GMP manufacturer and distributor of clinical and commercial radiopharmaceuticals. We work with our partners to transform patients’ lives by advancing high...

  • Associate I, Quality Assurance

    1 week ago

    Hamilton, ON LP A, Canada Omniabio Full time $60,000 - $90,000 per year

    Position Summary:As Associate I, Quality Assurance (QA), at OmniaBio, you are a motivated individual in the field of Good Manufacturing Practices (GMP) manufacturing of cell and gene therapy products who is driven by the opportunity to enable clinical translation of cell therapy and regenerative medicine. The QA team is responsible for all aspects of GMP for...

  • Quality Assurance Coordinator

    1 week ago

    Hamilton, Canada Walters Group Inc Full time

    The Quality Assurance Coordinator is responsible for assessing and maintaining the quality of the products and services at Walters both inside and outside of the company. **Main Responsibilities will Include**: - Ensures all procedures are being followed throughout all departments at Walters and performs annual internal audits of the Quality Management...

  • Quality Assurance Manager

    1 week ago

    Hamilton, Canada E.S. Fox Limited Full time

    For more than 90 years, **E.S. Fox Limited (ESFL)** has set the standard for safety and quality in the construction and fabrication industry. We have been unique in the industry as the ones who have helped build Canada’s infrastructure. We possess the insight and expertise to stand behind everything we do. **Our Strength is People** With a strong...

  • Associate I, Quality Assurance

    5 days ago

    Hamilton, Canada OmniaBio Full time

    Position Summary: - As Associate I, Quality Assurance (QA), at OmniaBio, you are a motivated individual in the field of Good Manufacturing Practices (GMP) manufacturing of cell and gene therapy products who is driven by the opportunity to enable clinical translation of cell therapy and regenerative medicine. The QA team is responsible for all aspects of GMP...

  • Quality Assurance Person

    1 week ago

    Hamilton, Canada GreenLife Full time

    **Summary** The Quality Assurance Person will establish and enforce quality standards and procedures within the facility. The position will ensure that all external and internal requirements are met before cannabis is made available for sale. This role aims to assure the high quality of our operations and services. **Requirements**: - have experience in...

  • Associate I, Quality Assurance

    4 weeks ago

    Hamilton, Canada OmniaBio Full time

    Position Summary As Associate I, Quality Assurance (QA), at OmniaBio, you are a motivated individual in the field of Good Manufacturing Practices (GMP) manufacturing of cell and gene therapy products who is driven by the opportunity to enable clinical translation of cell therapy and regenerative medicine. The QA team is responsible for all aspects of GMP for...