Manager, QA

2 weeks ago

Whitby, Canada Thermo Fisher Scientific Full time

As part of the Thermo Fisher Scientific team, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world’s toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer.

**How will you make an impact?**

You will ensure that products released to market meet quality, safety and efficacy. You will provide approval to disposition commercial and clinical study drugs for distribution. You will review and approve Manufacturing/Packaging Master Documents. You will be responsible for review and approval of validation protocols and reports. You will establish quality systems and provide drug regulatory expertise and support of day-to-day operations. You will lead, direct, train, coordinate and make decisions on quality issues.

**What will you do?**

**Essential Functions**:

- Directs investigations performed by Manufacturing/Packaging, Laboratory and Microbiology Laboratory departments, and evaluate all batches manufactured to ensure compliance with regulations as prescribed by the regulatory agencies
- Resolves Quality related issues within Manufacturing, Packaging, Microbiology Lab and Laboratory
- Responsible for document review groups within the QA department: QA Associates, and QA Document Reviewers
- Lead teams to have a quality presence on the production floor and in the laboratory, maintaining a real time review approach to mitigate errors as they occur
- Reviews and approves Manufacturing/Packaging Master Documents
- Reviews and approves validation protocols and reports
- Reviews and approves site, production and laboratory investigations
- Coordinate monthly quality metrics: Quality Council, QMR and Corporate Metrics

**How will you get here?**

**Education**:
B.Sc. in Chemistry, Microbiology or other related field. Degree in Microbiology is an asset.

**Experience**:

- Minimum 10 years experience in GMP environment
- Knowledge of Canadian Food & Drug Act, as well as U.S. cGMP and Canadian GMP regulations
- Managerial/Supervisory knowledge/experience
- Knowledge of Manufacturing processes
- Knowledge of Microbiology testing and equipment technologies.
- Familiarity with Good Manufacturing Practices.
- Knowledge of laboratory testing and equipment technologies

**Equivalency**:
Equivalent combinations of education, training, and relevant work experience may be considered.

Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one global team of 100,000 colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory at Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.

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