Quality Specialist

2 weeks ago

Mississauga, Canada BAXTER Full time

**This is where you save and sustain lives**

At Baxter, we are deeply connected by our mission. No matter your role at Baxter, your work makes a positive impact on people around the world. You'll feel a sense of purpose throughout the organization, as we know our work improves outcomes for millions of patients.

Baxter's products and therapies are found in almost every hospital worldwide, in clinics and in the home. For over 85 years, we have pioneered significant medical innovations that transform healthcare.

Together, we create a place where we are happy, successful and inspire each other. This is where you can do your best work.

Join us at the intersection of saving and sustaining lives—where your purpose accelerates our mission.

**Your Role at Baxter**:
To support the following major Quality Systems and ensure a state of compliance and continuous improvement:

- Training/Documentation
- NCR/CAPA
- Change Control
- Field Actions/Product Holds
- Product Release
- Annual Compliance (e.g. APQR Review, EBR Review, Stability Review)
- Quality/Distribution Agreements
- 3PL Oversight

**What you'll be doing**:
Provide support for the following activities within the Quality department
- Product Release including:

- Review of laboratory documentation, transportation and warehouse receiving documentation
- Disposition of imported and domestic product
- Communicate and collaborate with 3PL on issues, deviations and corrective/preventative actions related to product distributed in Canada.
- Communicate and collaborate with Quality Associates/Specialists/Sr. Specialists and manufacturing sites on issues, deviations and corrective/preventative actions related to product distributed in Canada.
- Communicate and collaborate with laboratories to ensure product is tested and results are provided in a timely manner.
- Communicate any issues that could impact product supply to Quality Operations partners.
- Manage and maintain all quality documents.
- Manage Quality Operations responsibilities associated with product compliance including but not limited to review and/or approval of compliance documentation such as APQR, Batch records, stability data, master manufacturing/packaging documentation.
- Provide review and support of tasks related to launching of new products, as required.
- Support review and approval of Quality/Distribution Agreements.
- Management of the Global document implementation program (1QSYS) locally; ensuring all Global policies and procedures are adopted fully and in a timely manner
- Optimization of the 1QSYS program
- Support 3PL oversight activities
- Providing Quality onboarding training sessions
- Lead and/or participate in departmental process improvement initiatives
- Administrative BAXU training system support
- Run Training reports, scorecards, and manage training dashboards
- Simplify and optimize Training transcripts at Head Office
- Development and maintenance of Head Office training plans
- Provide support, as required, to ensure products are launched in a timely manner.

**What you'll have**:

- University Degree and/or applicable post-secondary education and experience/ Major in Sciences/Health Sciences/Pharmacy
- 3-5 years in a related industry
- General knowledge of Quality systems (NCR/CAPA, Change Control, Documentation, Training, Product Release, Review of annual compliance documentation such as APQRs, initiate and implement Quality/Distribution Agreements in a GMP environment
- SOP/Technical Writing experience
- Experience in training plan development and conducting training
- Working in IT systems
- Experience working with a 3PL
- Excellent knowledge of GMPs and Health Canada regulations for drug products, biologics and medical devices
- Prior Quality Assurance experience in the Pharmaceutical or Medical Device Industry
- Drug and/or medical device product release/product disposition experience
- Strong communication and Technical Writing skills
- Strong ability to take initiative
- Good interpersonal/influencing/negotiation skills
- Self-motivated, self-directed and enthusiastic
- Good Project Management skills and ability to multi-task across many areas or projects
- Computer skills in MS Office (Word, Excel, Windows, Access) and Windows operating system
- Ability to grow and develop relationships with internal partners

**Nice to have**:

- University Degree in Sciences/Health Sciences with additional post-graduate training and certification in Quality Control/Quality Assurance / Chemistry, Biology, Engineering / Pharmaceutical Quality Assurance
- 5-7 years in a related industry
- Quality Operations in a GMP environment
- Experience reviewing master and executed manufacturing/packaging documentation
- Prior experience reviewing and approving compliance documentation
- Previous experience with Corporate and/or MoH audits
- Experience with laboratory methods and method transfers
- Strong understanding of Health Canada GMP & Medical Device Regulations
- Project Management

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