Change Control Specialist

at  Thermo Fisher Scientific

HOW WILL YOU MAKE AN IMPACT?

Functions as the Administrator for site Change Control records. Reviews, assesses, and provides Change Control approval on Change Controls.

EDUCATION:

Minimum College Diploma.
Bachelor of Science in Chemistry, Biology, Life Sciences preferred

EXPERIENCE:

Minimum 6 years experience in the pharmaceutical industry preferably in a QA function
Equivalency:
Equivalent combinations of education, training, and relevant work experience may be considered.

KNOWLEDGE, SKILLS AND ABILITIES:

Experience with TrackWise. Demonstrated computer proficiency with Microsoft Office programs. Strong written and oral communication skills. Understanding of Good Manufacturing Practices, International Conference of Harmonization (ICH) and United States Food & Drug Administration (FDA) requirements. Strong organizational skills and detail oriented. Ability to meet deadlines and prioritize. Able to work well independently and in team environment. Proficiency with the English Language.

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 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 occasionally.

• Acts as the lead and troubleshoots Change Control workflow issues and provides support to site Change Control users.
• Promotes the awareness of coming due records and drives actions from change owner departments.
• Collects information and generates Change Control status reports to support site Quality KPIs.
• Assists with internal/client audits and other regulatory questions.
• Provides job training to onboarding team members and refresher training to other teams involved in the Change Control process.
• Reviews and assesses Change Control records in TrackWise. Ensures all appropriate information is completed and supporting documentation has been attached to the record to support the requested change. Ensures the change is in compliance with appropriate GxPs.
• Reviews and assesses completed Action Item Child Records for accuracy and compliance.
• Provides final post-approval on Change Control records in TrackWise. Ensures the Implementation Plan was followed and closes Change Control records as per Change Control procedure.
• Acts as the Change Review Board Administrator and responsible for coordinating and/ or facilitating Change Review Board meetings.
• Maintain a safe working environment and report potential hazards.