QA Associate I

2 weeks ago

Mississauga, Ontario, Canada Thermo Fisher Scientific Full time

Summary:


Ensure all documentation related to the successful release of a finished product is complete and conform to all Patheon Standard Operating Procedures (SOPs), client requirements and current Good Manufacturing Practices (GMPs).


Essential Functions:

  • Review executed processing and packaging batch records and associated E-Data as per established procedures and client requirements to meet departmental/client schedule, if applicable.
  • Communicate with clients on any questions or concerns regarding Patheon's procedures and/or documentation for batch records.
  • Execute release of bulk and finished products by updating SAP system, for further packaging.
  • Work on special projects relating to the Quality Department's Continuous Improvement Plan.
  • Perform associated Quality on the floor tasks, including but not limited to, participation in RAPIDS and review of production logbooks
  • Provide support to Processing and Packaging teams with Quality on the floor tasks
  • Follow up on executed batch record comments with the processing and packaging departments
  • Initiate deviations in Global TrackWise and write QA Investigations
  • Maintain a safe working environment and report potential hazards.
  • Collect data to perform and support Department Metrics
  • Perform alternating or rotating shift work (as required)

REQUIRED QUALIFICATIONS

Education:

College/Technical Diploma preferably in Science

Bachelor of Science Degree or related field an asset

Experience:

Minimum 1 year previous experience in the pharmaceutical/food/cosmetic industry, preferably in a QA function.
Experience with SAP (an asset).

Equivalency:

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

Knowledge, Skills and Abilities:

Ability to work well independently and in team environment. Excellent organizational skills. A strong focus on accuracy and attention to detail. Ability to multi-task, meeting tight deadlines 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.

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 Patheon quality systems Standard Operating Procedures (SOPs) and Good Manufacturing Practice (GMP).

Maintain workspace in a clean and orderly fashion.

Actively engage in and adhere to departmental systems 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.

Physical Requirements:

Light 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.

Disclaimer:

This job description is intended to present the general content and requirements for the performance of this job. The description is not to be construed as a comprehensive statement of work, responsibilities, or requirements. Managers and supervisors may assign other duties as needed.

Nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms.

Any language contained herein is intended to fully align with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees.

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