System Administrator

2 weeks ago

Mississauga, Canada Thermo Fisher Scientific Full time

**System Administrator - Lab Operations**

**Summary**:
**Essential Functions**:

- Assist internal and external audits (when applicable), including regulatory and customer audits.
- Assist in 21 CFR part 11 compliance and regulatory activities.
- Assist in building and maintaining technical troubleshooting body of knowledge library.
- Assist in the administrative duties on standalone systems for adding/removing users, troubleshooting, printing and reviewing audit trails and annual user reviews and report preparation.
- Perform monthly and yearly review of excel validated spreadsheets for compliance to procedures.
- Provide end user training and support as needed
- Maintain a safe working environment and report potential hazards.
- Perform alternating or rotating shift work (as required)

**REQUIRED QUALIFICATIONS**

**Education**:
Bachelors Degree in Science or Computer Science or similar field of study

**Experience**:
Minimum 5 years laboratory experience.

Knowledge of 21CFR Part 11 compliance

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

**Knowledge, Skills and Abilities**:
Excellent verbal communication and written, with active listening and summarization skills. Experience with LIMS is preferred. Sound knowledge of Good Manufacturing Practices. Sound understanding of Standard Operating Procedures. Business process knowledge of Quality Management, Lab Operations, and Lab Information Management Systems. Ability to make quality decisions. Demonstrated computer proficiency with Microsoft Office programs. Proficiency with the English language.

**Standards and Expectations**:
Follow all Environmental Health & Safety Policies and Procedures. Work harmoniously 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 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 of deliverables in a proactive manner. Consistently strives to improve skills and knowledge in related field.

**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 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.

**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 regular 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.

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