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QC Microbiology Compliance Specialist (24 months)

Baxterabout 1 month ago
Alliston, Ontario
Senior Level
full_time

About the role

This is where your work makes a difference.

At Baxter, we believe every person—regardless of who they are or where they are from—deserves a chance to live a healthy life. It was our founding belief in 1931 and continues to be our guiding principle. We are redefining healthcare delivery to make a greater impact today, tomorrow, and beyond.

Our Baxter colleagues are united by our Mission to Save and Sustain Lives. Together, our community is driven by a culture of courage, trust, and collaboration. Every individual is empowered to take ownership and make a meaningful impact. We strive for efficient and effective operations, and we hold each other accountable for delivering exceptional results.

Here, you will find more than just a job—you will find purpose and pride. 

Your Role at Baxter

This is where my hands make life-sustaining products  

You are driven by the knowledge that the products you help make saves and sustain lives. You can move quickly, address questions, and encourage teammates, all while getting quality products out on time. You are calm, positive, and a key part of a fast-paced environment that emphasizes camaraderie and teamwork. As a QC Microbiology Compliance Specialist, you are happiest when you are moving, and we will not disappoint!

 

Baxter is known for its speed and high-quality product. Our manufacturing operations are around-the-clock to meet the needs of our customers. Our high-caliber talent works through the challenges at hand while pushing toward meeting client order needs. We are currently looking for a Microbiologist to work a 24-month, full-time contract position on our D

ay

shift (Monday to Friday 8:00h-16:30h EST),

at our Alliston facility!

Your team

 

Baxter is focused on saving and sustaining lives by manufacturing high-quality products. We strive to create quality products for our customers each day.

 

Delivering life-saving products is about getting them right, and attention to detail is how we make sure we meet that challenge. We are a team that supports each other throughout each shift. Working together in a supportive and open culture makes our processes evolve for the better and engages our workforce.

 

The following are dress/gowning requirements: safety glasses, safety shoes, ear plugs, jumpsuit, hood, hairnet, beard cover, gloves, isolation mask and boots (additional PPE required when cleaning)

 

  • Constant or intermittent exposure to elevated levels of noise
  • Involves working around equipment, machinery, and belts

What You'll be Doing:

  • Responsible for coordinating with the Microbiology Manager and Supervisors to ensure compliance to required timelines for the completion of all Microbiology NCRs, CAPAs, OOLs and training.

  • Schedules, coordinates and performs investigations associated with Microbiology data non-conformances with all involved Microbiologists.

  • Determines through observations, in-depth employee interviewing and flow charting, the issues and elements of the process or system which potentially prevent an individual from performing a function correctly or act as a deterrent to the proper performance of the function.

  • Monitors Microbiologists training status to maintain compliance to the training curriculum.

  • Monitors the status of review for the lab to ensure that all records are complete and up to date.

  • Tracks batch release dates to ensure that the lab is on target to meet dates.

  • Performs document changes for the laboratory.

  • Supports completion of CAPA tasks.

  • Tracks all CAPAs to closure ensuring timeliness of all actions including correction/containment, investigation, corrective/preventive

    actions/effectiveness and closure.

  • Reviews Corporate Quality Procedures and policies and new/revised Health Canada guidance documents/regulations to ensure local procedures are maintained appropriately.

  • Performs instructor led training with the Microbiologists.

  • Creates trending reports for product results and environmental monitoring.

What You'll Bring:

  • University Degree, Bachelor of Science

  • Experience in writing OOL and/or non-conformance investigations

  • Manufacturing & Quality background

  • Previous experience in a GMP environment

  • Knowledge of GMP, ISO and Regulatory standards

  • 2 – 3 years experience in a pharmaceutical environment

  • Strong understanding of Health Canada GMP and Medical Device Regulations.

  • Thorough knowledge of applicable procedures, specifications, regulations and standards.

  • Strong process and project management capabilities.

  • Strong written and oral communication skills, negotiation 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.

  • Role model personal accountability for results and integrity and relentless focus on rapid and disciplined action.

  • Strong analytical and problem solving skills and critical thinking abilities.

  • Intermediate to Advanced proficiency in Word, Excel, Powerpoint.

  • Must interpret regulations and standards based on good quality practices and good business requirements.

  • Must be able to build good relationships with internal and external customers.

  • Maintain technical expertise and method/procedure knowledge to support good decision making.

  • Maintain quality and patient safety first while recognizing the importance of good business decisions.

#IND-CA Equal Employment Opportunity Baxter is an equal opportunity employer. Baxter evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.

Reasonable Accommodations Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities globally. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please click on the link here and let us know the nature of your request along with your contact information.

Recruitment Fraud Notice

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About Baxter

Pharmaceutical Manufacturing
10,000+

For nearly a century, we have delivered on our commitment to saving and sustaining the lives of patients, working alongside clinicians and providers around the world. We believe every person — regardless of who they are or where they are from — deserves a chance to live a healthy life, free from illness and full of possibility. At the intersection of progress and purpose is where we are redefining what it means to be a global medtech leader. It is where we are relentlessly pursuing healthcare transformation, fueled by our compassion for patients and providers and the challenges they face. It is where bold ideas meet the promise for meaningful change in the world around us. We are there, at every step of the journey, to help clinicians deliver the best care possible.