Investigations Coordinator - Co-Op

Work Schedule: Standard (Mon-Fri)

Environmental Conditions: Office

Job Description:

Summary: Support the Investigation Team by compiling data and required documentation for investigations. Maintain the Investigation Huddle board and associated Investigations tracking files. Assist the Investigation Team by monitoring and reporting metrics to proactively identify risks for action assignment. Generate data and track key performance metrics in support of creating quarterly trend reports. Participate and contribute to departmental meetings and huddles. Revise standard operating procedures (SOPs) for investigations when required.

Essential Functions:

• Support the maintenance of the Investigation Huddle board and associated Investigations tracking files.
• Revise Investigation procedures through eDMS when required.
• Support the Investigations Team by compiling data and supporting documentation for assigned investigations (i.e. pull SFLMS training reports, SOPs that were effective at the time of the event, etc.).
• Support minor investigations.
• Support the investigation team to meet all necessary administrative tasks in a timely manner.
• Support the Investigation Team Lead as required.
• Support investigation related projects.
• Maintain a safe working environment and report potential hazards.
• Perform alternating or rotating shift work (as required).

REQUIRED QUALIFICATIONS

Education: High school diploma/General Educational Development (GED) Certificate is required. Working towards a Bachelor of Science (B.Sc.) in chemistry, biology, life sciences, or a related field.

Experience: Requires no previous related experience.

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

Knowledge, Skills, and Abilities: Strong interpersonal skills. Knowledge of Good Manufacturing Practices, Standard Operating Procedures, and Corrective Action Preventative Action (CAPA) is an added value. Good organizational skills with a proven ability to prioritize when timeline conflicts exist. Detail oriented. Ability to discretely deal with Confidential information. 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, modeling positive team principles and partnering to meet project and departmental objectives. Carry out all duties within strict compliance to Patheon quality SOPs and Good Manufacturing Practices (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 fields.

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 a 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 odors, 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, and respirator occasionally.