Manager Quality Assurance Cyclotron Radiopharmacy

6 days ago

Thunder Bay, Canada Thunder Bay Regional Health Sciences Centre Full time

**Ref# 23NON077RU**

**1 ‑ Full Time ‑ Manager Quality Assurance**

**Cyclotron‑Radiopharmacy**

Reporting to the Director of Cyclotron Operations (DOC), the Quality Assurance (QA) Manager supervises the quality

program to ensure facility compliance with applicable government regulations and GMP guidelines.

Employment Requirements:

- An advanced degree in a relevant scientific discipline
- Minimum 5 years working in a GMP environment (e.g. radiopharmacy)
- Minimum of 5 years working in a QA role in the pharmaceutical manufacturing industry
- Knowledge of Health Canada GMP regulations
- Experience working in a sterile manufacturing environment
- Experience with manufacturing and quality control process validation
- Must be able to work well under pressure with dynamic deadlines and priorities
- Strong organizational skills
- Ability to make decisions based on judgement and integrity
- Ability to identify compliance risks and escalate them if necessary
- Strong attention to detail with an eye for quality and accuracy

Roles and Responsibilities:

- Lead and provide direction and supervision to a team of Quality Assurance and Quality Control staff
- Assist in planning and monitoring the cyclotron and radiopharmacy budget
- Develop and maintain Quality Systems in accordance with Health Canada regulations
- Act as independent authority on all aspects of quality pertaining to radiopharmaceutical production
- Act as the batch release authority for radiopharmaceuticals intended for human use
- Lead the process for corrective actions and close out of investigations of deviations related to Corrective and

Preventative Actions (CAPAs) and Out of Specification (OOS) reports
- Conduct training in quality related issues as required
- Lead the processing and tracking of product complaints, recalls and adverse drug reaction assessments and

submissions of related reports to Health Canada
- Coordinate internal audits / self inspections to ensure company operations and documentation are in compliance

with International Council for Harmonisation (ICH), Good Manufacturing Practice (GMP), applicable regulations and

company Standard Operating Procedures (SOPs)
- Review SOPs, test methods, deviations, investigations, change controls, Certificates of Analysis (CoAs), protocols

and reports
- Lead the development of QA metrics

Salary Range: $40.803 to 48.003

The Health Sciences Centre strives to ensure the safety and security of the patients, visitors, employees and assets

Criminal Records Check (CRC) where indicated, to ensure the absence of relevant criminal convictions; and proof of

full vaccination of all required doses of a COVID‑19 vaccine approved by Health Canada to Occupational Health &
Safety.

The Health Sciences Centre (HSC) is committed to delivering healthcare in a manner that is consistent with Patient

and Family Centred Care. Applicants are required to have a demonstrated knowledge, understanding and

commitment to this care philosophy.

imperative, therefore, all applicants will have to demonstrate a good attendance record to be considered for this

position.

We are committed to fostering an inclusive, equitable, and accessible environment supporting diversity in our work

environment to provide quality care where all feel valued, respected, and supported. We are dedicated to building a

workforce reflective of the communities in which we live and serve and encourage Indigenous people, visible

are available throughout the selection process. Additionally we are identified as an English/French speaking health

If there are no qualified applicants for the above position, the Hospital may, at their discretion, train unqualified

individuals.

Interested applicants must submit a resume outlining relevant previous experience and training. **This position will**

**remain posted until filled.**

website.

Posted: February 16, 2024

NON UNION

Pay: $40.80-$48.00 per hour

**Benefits**:

- Dental care

Flexible language requirement:

- French not required

**Education**:

- Bachelor's Degree (preferred)

**Experience**:

- quality assurance: 1 year (preferred)

Work Location: In person

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