Quality Assurance Specialist

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Ready to explore, break barriers, and discover more? We know you've got big plans - so do we Our colleagues across the globe love innovating with science and technology to enrich people's lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That's why we are always looking for curious minds that see themselves imagining the unimaginable with us.

United As One for Patients, our purpose in Healthcare is to help create, improve and prolong lives. We develop medicines, intelligent devices and innovative technologies in therapeutic areas such as Oncology, Neurology and Fertility. Our teams work together across 6 continents with passion and relentless curiosity in order to help patients at every stage of life. Joining our Healthcare team is becoming part of a diverse, inclusive and flexible working culture, presenting great opportunities for personal development and career advancement across the globe.

This role does not offer sponsorship for work authorization. External applicants must be eligible to work in the US.

**Your Role**:
Reporting to the Head of Quality (QA), the purpose of the Quality Assurance Specialist role is to support the Head of QA in the performance of Quality and Compliance tasks for with regards to GMP and GDP requirements (including Medical Device guidelines) as well as.

Support the Head of Quality with the implementation of the defined Global Healthcare Operations strategy and ensure the implementation and monitoring of the Quality Management System and their continuous improvement.

Tasks will include the management of product release (as applicable), documentation, metrics / trend reports for both complaints and deviations. In addition, this role will provide assistance with the management of complaint management activities e.g. reporting, trend analysis etc.

Another key area of this role is the maintenance and creation of Standard Operating Procedures and Work Instructions, aligned with HCQ requirements; ensuring documents are available via Mango.

**Location**: Onsite - Mississauga

**Key Responsibilities
- Manage the Complaints Process including the investigation process. Maintenance of all appropriate documentation, recording and investigation of customer complaints via the complaint database TrackWise; return of complaint samples to manufacturing sites for investigation purposes and provision of information to complainants as required (complaint responses)
- Adherence to the Change Control and Deviation procedures including data entry into the electronic system, TrackWise
- Responsible for the compilation, tracking and sharing of trend reports, working with stakeholders to propose appropriate CAPAs.
- Assist with the creation and maintenance (periodic review) of Quality Standard Operating Procedures and Work Instructions and ensuring procedures are available via Mango.
- Release for Sale at Subsidiaries, if applicable: verification of relevant documents to confirm compliance of products received and on time local release for sale to market.
- Product Returns: assessment of product returns and supporting information to verify if products are suitable for return to saleable status or destruction.
- Management of quality activities impacted by Canadian Subsidiaries.
- Participate in the Right First Time objective as part of product release activities and work with stakeholders to share the information and improve local processes as necessary
- Assist with preparing training presentations as needed e.g. for relevant GxP SOP's & WI's
- Assist with audit management planning and execution including the tracking of CAPA plans through to closure
- Assist with Risk Management activities
- Actively participate in the EMD Serono Canada Performance Management Process and Personal Development plan
- To recognize a reportable Adverse Event (AE) or Safety Information and ensure the information is forwarded to the Local Patient Safety Person (LPS) in EMD Serono Canada within 24 hours
- Assist with the Adverse Event / Product Complaint reconciliation process
- Act as a local Quality Learning Coordinator (as applicable)Perform other functions and duties that may be assigned by the Head of Quality.

**Minimum Requirements**:

- Bachelor's degree in Pharmacy, Chemistry, or related Life sciences discipline
- 1+ years of working Canadian experience in Quality Assurance or Regulatory Affairs role
- Prior documentation, recording and investigation of customer complaints experience

**Preferred Requirements**:

- Background in Medicinal product distribution highly desirable
- Preferably at least 3 years' experience related to Quality Assurance in pharmaceutical industry
- Experience in Good Distribution Practices
- Knowledge in local laws and local regulations applicable to the operation
- Willingness and enthusiasm to learn new skills
- Time ma