How will you make an impact?
You will initiate and lead/coordinate the investigation and work with the appropriate parties related to product Deviation Reports (DRs). The position will respond to both Packaging & Processing deviations. This position is also responsible for trending issues, especially as it relates to gaps that are identified in root cause investigations.
What will you do?
Essential Functions:
Incident Report Process:
Accepts Operations related DRs and initiates and leads the investigation.
Evaluates the thoroughness of the investigation and determines root cause.
Assigns the root cause and proposes and assigns Corrective Action Preventative Action (CAPA).
Manages the Operations trending tool to help validate identification and elimination of root cause.
Follows up on CAPA actions and owns the responsibility of keeping the follow-up actions current.
How will you get here?
Education:
Bachelor of Science or Bachelor of Applied Science or related field
Experience:
3 years of manufacturing experience in pharmaceutical, food or cosmetics industry, with knowledge of batch packaging principles.
At least one year experience in technical writing or scientific writing.
Equivalency:
Equivalent combinations of education, training, and relevant work experience may be considered.
Competencies:
Strong interpersonal skills.
Understanding of Good Manufacturing Practices, Standard Operating Procedures and CAPA.
Good organizational skills with ability to prioritize.
Ability to problem solve and troubleshoot.
Ability to carry out investigations in a collaborative manner with production staff and to effectively interact with internal and external suppliers and clients.
Microsoft skills (Word, Excel, PowerPoint).
Proficiency with the English language (oral and written).
At Thermo Fisher Scientific, each one of our 70,000 extraordinary minds has a unique story to tell. Join us and contribute to our singular mission—enabling our customers to make the world healthier, cleaner and safer.
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