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QA Associate II (Batch Reviewer)

Thermo Fisher Scientificabout 2 months ago
Mississauga, ON
Mid Level
full_time

About the role

Work Schedule

Rotational days/weekends

Environmental Conditions

Office

Job Description

Schedule: Sun- Thurs 3.30pm to 11:30 pm OR Tues to Sat 3.30pm to 11:30 pm

As a QA Associate II in Mississauga, you will join a world-class team driven by innovation and outstanding standards. This is your opportunity to thrive in a collaborative and inclusive environment while making a significant impact on global health and safety.

Job Responsibilities

  • Review completed manufacturing and packaging batch records and associated E-Data as per established procedures and client requirements to meet departmental/client schedule, if applicable.

  • Ensure all documentation related to bulk and finished product release is collected and compiled prior to release.
  • Complete release of bulk and finished products (and product rejections if required) by updating SAP system, prepare release documentation.
  • Perform Conditional release for batches with deviations if applicable or Ship in Quarantine if applicable
  • Initiate and participate in investigations
  • Perform associated Quality on the floor tasks, including but not limited to, participation in RAPIDS and review of Production logbooks
  • Work on special projects relating to the Quality Department’s Continuous Improvement Plan and support in gathering metrics
  • Maintain a safe working environment and report potential hazards.
  • Collaborate with cross-functional teams to determine and resolve quality issues.
  • Maintain accurate documentation of QA activities and findings.

Job Requirements

  • Bachelor's degree or College/Technical Diploma in a related field preferably in Science.
  • Proven experience in a QA role, Minimum 3 years previous experience in the pharmaceutical/food/cosmetic industry, preferably in a QA function.
    Experience with SAP preferred
  • Ability to work well independently and in team environment.
  • Excellent organizational skills.
  • A strong focus on accuracy and attention to detail.
  • Ability to prioritize and work efficiently to meet tight timelines in a fast paced environment.
  • Excellent interpersonal and communication skills (oral and written). Familiarity with Good Manufacturing Practices. Demonstrated computer proficiency with Microsoft Office programs. Proficiency with the English language.
  • Excellent communication skills and the ability to work in a team-oriented environment.
  • Knowledge of regulatory standards and quality assurance principles.
  • Ability to support alternating or rotating shift work.

Physical requirements include l****ight physical effort and fatigue. Walks, sits or stands for limited periods. May require occasional equipment operation including keyboard equipment. Lifts light items for limited duration. Typically located in a comfortable indoor area. There may be exposure to mild physical discomfort from factors such as dust, fumes or odours, temperature extremes, loud noise, strong drafts, or bright lights.Use of Personal Protective equipment may be required and may include any of the following: safety glasses, safety shoes, lab coat, gloves, hair net, beard cover, safety apron, respirator on occasionally.

About Thermo Fisher Scientific

Biotechnology Research
10,000+

About Thermo Fisher Scientific Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue of approximately $40 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, increasing productivity in their laboratories, improving patient health through diagnostics or the development and manufacture of life-changing therapies, we are here to support them. Our global team delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon and PPD.

For more information, please visit www.thermofisher.com.