Release Technician

3 weeks ago

New Tecumseth, 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.

Ensure compliance to current Quality system, Regulatory and Corporate requirements related to Final Product Release, Document Maintenance and Management and Exception Management in the Alliston Manufacturing Facility.

Major Responsibilities

Product Release

Perform the Batch Release Review of final product in a timely manner while ensuring product and manufacturing operations conform to specifications, Standard Operating Procedures and Product Structures, in order to maintain customer service levels.

Quality Exceptions Management

Maintain the Quality Exceptions Log

Critical Systems Approval

Approve critical systems acceptability for batch release, and system monitoring documentation by verifying integrity of all data generated and reported for conformance to specifications, Standard Operating Procedures and GMP requirements.

Batch Documentation Management

Manage and maintain organization of all quality documents in the Documentation Centre.

Provide support to the Quality Operations Manager and Supervisor in maintaining Standard Operating Procedures relating to Document Centre Management and Product Release.

Other

Support the preparation of monthly Quality Operations Metrics Support department 6S efforts by maintaining all work areas in a clean & orderly state.

Education Level

Required:

University Degree, Bachelor of Science / Microbiology, Chemistry, Biological Sciences, Engineering

Preferred:

 Bachelor's Degree in Science.

Major Subjects / Specialties

Required

Mathematics Computer skills

Type of Experience

Required:

Proven ability/strength in Good Documentation Practices with attention to detail. Previous record keeping, QA or QM experience. Previous manufacturing experience within a GMP environment.

Preferred:

Previous Manufacturing or Quality experience within a GMP environment. Knowledge of GMP, ISO standards, and regulatory/corporate requirements. Practical experience using Lean tools (6S, Kaizen, Value Stream Mapping)

Years of Experience

Required:

 1 -3 years

Preferred:

3+

Additional Skills / Special Training / Technical Skills Required

Required:

Strong communication skills, ability to work with all levels of the organization. Ability to build strong relationships with internal and external customers. Strong ability to balance multiple priorities with excellent time management skills. Detail oriented with the ability to work under pressure. Ability to work in a team environment as well as the ability to be self-motivated and be able to work with minimum supervision. Strong analytical and problem-solving skills and critical thinking abilities. Intermediate proficiency in Word, Excel & PowerPoint.

Preferred:

 Experience in a wide variety of positions within the plant  Previous experience with AS400, EBR, Trackwise, JD Edwards

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