Quality Systems Associate - Whitby, Canada - Thermo Fisher Scientific

Thermo Fisher Scientific

Verified Company

Whitby, Canada

2 weeks ago

Posted by:

Sophia Lee

beBee Recruiter

Description

As part of the Thermo Fisher Scientific team, you'll discover meaningful work that makes a positive impact on a global scale.

Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer.

We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world's toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer.

How will you make an impact?
Support the oversight of

Quality Systems:
Investigations, CAPAs, and Change Controls. Perform as Global TrackWise Administrator, and Power BI Subject Matter Expert for the Whitby Site. Perform routine reporting of key quality systems metrics in support of daily, weekly and monthly forums. Perform investigations for Quality Operations deviations to identify root cause and propose appropriate CAPAs to prevent recurrence. Support corporate and client audits, in addition to client regulatory inspections.

What will you do:

Perform as Global TrackWise (GTW) Administrator for the Whitby Site
Perform as Power BI Subject Matter Expert
Perform investigations in TrackWise for Quality Operations deviations to identify root cause and propose appropriate CAPAs to prevent recurrence
Monitor performance of Investigations / Deviations, CAPAs, and Change Controls through identification, monitoring, trending, and reporting of key performance indicators.
Prepare the agenda and content for Quality Systems daily huddles and weekly review boards in support of driving the performance of Quality Systems, facilitate when required.
Support Regulatory Inspections, Corporate Audits, and Client Audits specific to the functions within the Quality Systems team.
Support special projects as assigned.
Maintains a safe working environment and reports potential hazards.

How will you get here:

Education:

Bachelor of Science (B.Sc.) in Chemistry, Pharmacy or a science related to pharmaceutical analysis.

Experience:

Minimum 2 years experience in a regulated industry.

Equivalency:

Equivalent combinations of education, training, and relevant work experience may be considered.

Knowledge, Skills and Abilities:

Demonstrated computer proficiency with Microsoft Office programs. Proficiency with the English Language. Strong ideas, decision making abilities, trouble shooting and thinking-out-of-the-box skills. Excellent organizational, verbal and written communication skills. Familiarity with GMPs. Works well with limited supervision. Excellent organizational, interpersonal, oral and written communication skills. Experience in Microsoft Word, Excel, Access. Experience with EDMS, SuccessFactors LMS is an asset.

Standards and Expectations:

Follow all Environmental Health & Safety Policies and Procedures. Work collaboratively with fellow team members, modelling positive team principles and partnering to meet project and departmental objectives. Carry out all duties within strict compliance to quality systems SOP's and Good Manufacturing Practice (GMP). Maintain workspace in a clean and orderly fashion.

Actively engage in and adhere to departmental systems in order to maintain a smooth and efficient workflow (visual management, scheduling systems, etc.).

Be client and patient conscious at all times.

Understand Key Performance Indicators and strive to improve the performance of the team by identifying areas for system improvements and engage in problem solving.

Models positive thinking and is open to change, motivating the team to adapt to shifts in priorities and new ways of working.

Proactively identify areas for improvement in the execution of procedures. Communicate risks to timelines in a proactive manner. Consistently strives to improve skills and knowledge in related field.

Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us.

As one global team of 100,000 colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need.

#StartYourStory at Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.