Senior Investigations Associate

Thermo Fisher Scientific•Whitby, ON

2d•CA$69,400 - CA$104,050•Onsite

About The Position

The Senior Investigations Associate will be responsible for conducting internal, external, and client Good Manufacturing Practices (GMP) audits. This role involves performing audits of all departments, preparing written reports, participating in site Fit and Finish Audits, and facilitating site preparations for client and regulatory inspections. The associate will also assist with regulatory requests, manage audit observations and CAPAs, provide administrative support for compliance projects, and maintain a safe working environment.

Requirements

Bachelor of Science (B.Sc.) in chemistry, biology, pharmacy, or other related field.
Minimum 3 years of Good Manufacturing Practices /Good Lab Practices auditing experience.
Exceptional Good Manufacturing Practices, GLP, and HPBI/FDA compliance knowledge.
Proficiency with the use of quality investigation tools – FMEA, Fishbone, etc.
Familiarity with SFLMS.
Familiarity with managing GMP regulatory requests.
Detail-oriented and organized, with a high degree of accuracy and thoroughness.
Excellent organizational skills and ability to prioritize in a fast-paced environment.
Strong written and oral communication skills.
Works well and efficiently with limited supervision.
Demonstrated computer proficiency with Microsoft Office programs.
Proficiency with the English Language.
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 with Patheon quality systems 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 engaging in problem-solving.
Models positive thinking and is open to change, motivating the team to adapt to shift 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.

Nice To Haves

Experience with SAP (an asset).
Equivalent combinations of education, training, and relevant work experience may be considered.

Responsibilities

Perform internal Good Manufacturing Practices audits of all departments as required and prepare written reports to document the findings.
Participate in the site Fit and Finish Audit.
Facilitate site preparations and execute audits for clients and regulatory inspections including regulatory awareness programs for each agency.
Assist with ongoing guidance and training of auditors (if applicable).
Assist with regulatory requests.
Manage Audit Observations and Audit CAPAs.
Provide administrative support for ongoing Compliance projects.
Maintain a safe working environment and report potential hazards.