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Quality Assurance Specialist

2 months ago


Alliston, Ontario, Canada Baxter Full time

About Us

Baxter is a leading global healthcare company that is deeply connected by its mission to save and sustain lives. Our work has a positive impact on people around the world, and we are proud to be a part of it.

Our Mission

We are committed to pioneering significant medical innovations that transform healthcare. Our products and therapies are found in almost every hospital worldwide, in clinics, and in the home.

Our Opportunity

We have an exciting opportunity at our Manufacturing facility in a location near Toronto. As a Chemist, you will play a critical role in ensuring the quality of our products.

Key Responsibilities

  • Perform chemical analysis to ensure product acceptability.
  • Ensure that final products meet required standards before release by analyzing them using instrumental and wet chemical techniques according to the specifications.
  • Analyze in-process samples using a variety of assays and procedures, taking appropriate action if the result is out of the specified limits.
  • Maintain the chemistry lab in good order.
  • Perform analytical chemical analysis to ensure products meet required standards using instrumental and wet chemical techniques according to specifications.
  • Compile analysis reports by entering results into the Laboratory Information Management System (LIMS) approving them and forwarding to the Document center.
  • Ensure that production lines make products within specification limits by analyzing in-process samples using a variety of assays and procedures, taking appropriate action if the result is out of specified limits.
  • Support departmental 6s efforts by maintaining all work areas in a clean and orderly state, disposing of waste, cleaning glassware, and removing expired chemicals/reagents.
  • Maintain the chemistry lab in good order by housecleaning, disposing of waste, cleaning glassware, and removing expired chemicals/reagents.
  • Perform required preventative maintenance on equipment in the QM lab to ensure proper functioning and delivery of consistent and reliable results.
  • Contact manufacturers of equipment and arrange for service in the event of malfunction of equipment.

Qualifications

  • University Degree, Bachelor of Science Majoring in Analytical Chemistry or Biochemistry.
  • 3-5 years of analytical chemical testing lab experience.
  • Over 2 years of chemical lab experience in a pharmaceutical industry is preferred.
  • Familiarity with laboratory equipment in a Quality Management Laboratory.
  • Proficiency in MS Office and laboratory computerized systems.
  • Must have strong organizational and time management skills.
  • Highly effective analytical and problem-solving skills and critical thinking abilities.
  • Highly effective communication and interpersonal skills.
  • Experience performing analytical testing in compliance with specification requirements - Instrumental techniques such as HPLC, ICP-MS, GC Atomic Absorption, UV-VIS spectroscopy, Flame Photometry, and IR spectroscopy.
  • Knowledge of GMP, ISO, and regulatory requirements.
  • Familiarity with LIMS is an asset.
  • Technical writing experience is an asset.