Compliance Specialist - Quality Agreements

Thermo Fisher Scientific • Whitby, ON

1d • CA$54,600 - CA$84,600 • Onsite

About The Position

To provide primary support for establishing and updating Quality Agreements with PDS and Commercial clients to meet corporate, site, and regulatory requirements. The secondary emphasis, the investigation of Incoming Material Defects, representing quality during Internal, Client, and Regulatory Audits, review of Standard Operating Procedures (SOPs), support Vendor Change Management, and any other function deemed necessary to support Quality Culture within the organization.

Requirements

• College Diploma in relevant technical field
• Minimum 3 years’ experience in a pharmaceutical or related industry.
• Knowledge of GMP, HPFBI, FDA and SOP requirements.
• Excellent interpersonal, organizational, oral, and written communication skills.
• Attention to detail.
• 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 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.

Nice To Haves

• Bachelor of Science (B.Sc.) in chemistry, biology, life sciences or a related field an asset.
• Previous experience in Compliance or Quality an asset.
• Experience with Technical Writing is a plus
• Proficiency in Documentum an assett
• Proficiency in TrackWise an asset.

Responsibilities

• Support preparation of and updating Quality Agreements for PDS and Commercial clients.
• Investigate Incoming Material Defects with input from the vendor, client and internal departments.
• Support Vendor Change Management through assessment of the change to ensure compliance to corporate, site, regulatory and client requirements.
• Participate in the internal, client and regulatory audits.
• Support regulatory requests.
• Oversee the process related to on time retention sample destruction.
• Maintain a safe working environment and reports potential hazards.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: Associate degree