LES Project Assistant - Co-Op

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.), Will work with hazardous/toxic materials

Job Description

Summary:

Responsible for supporting the implementation and deployment of the Laboratory Information Management System (LIMS), with a primary focus on creation of lab methods needed for the Lab Execution System (LES). The role consists of reviewing and learning existing lab methods, consulting with scientists who use those methods, and building and testing methods in digital format using the SM-LES system.

Essential Functions:

• Create new lab methods as digital workflows in the SM-LES system, using paper-based lab methods as templates.

• Support the deployment of simple instruments and calibrations using the SM-LES system.

• Provide support to LIMS project through updates to electronic sample database for both analytical and microbiological laboratories. Examples include: stability studies, sample tracking, logging, method workflows.

• Maintains detailed and accurate records to meet all regulatory and user requirements.

• Follows all current SOPs and procedures.

• Maintains a safe working environment and reports potential hazards.

• Works with and advises staff an administrative policies and procedures.

• Provides timely assistance to lab chemists and supervisors when requested.

• Supports Sample Manager deployment activities.

• Develop Work Instruction (WI) related to Standard Operating Procedures (SOPs) as required.

REQUIRED QUALIFICATIONS

Education:

High school diploma/General Educational Development (GED) Certificate is required

Working towards a College Diploma or University Degree in a chemistry or related related field of study.

9-12 month commitment period is essential.

Experience:

Previous experience in a science related environment.

Equivalency:

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

Knowledge, Skills and Abilities:

Good proficiency using Microsoft Office suite tools (MS Word, MS Excel). Good understanding of basic chemistry and experience with common laboratory equipment and operation. Knowledge of qualitative and quantitative chemical or microbiological analysis. Awareness of quality and regulatory requirements in the pharmaceutical industry. Good problem-solving skills and logical approach to solving scientific problems. Demonstrable interpersonal and communication skills (both oral and written). Ability to read and interpret technical procedures and governmental regulations. Ability to apply mathematical operations to such tasks as determination of test reliability, analysis of variance, and correlation techniques. Proficiency with the English language. Works well independently and in a team environment.

**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:

Position requires ordinary ambulatory skills and physical coordination sufficient to move about lab/office locations; ability to stand, walk, stoop, kneel, crouch periodically for prolonged periods of time; manipulation (lift, carry, move) of light to medium weights of 10-35 pound pounds; arm, hand and finger dexterity, including ability to grasp and type for prolonged periods of time; visual acuity to use a keyboard, computer monitor, operate equipment, and read materials for prolonged periods of time; ability to sit, reach with hands and arms, talk, and hear for prolonged periods of time. Safety glasses, safety shoes, lab coat, latex or similar gloves, safety apron, organic respirator occasionally.

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.