Deviation Investigation Writer II
at Thermo Fisher Scientific
St. Louis, MO 63134, USA -
Start Date | Expiry Date | Salary | Posted On | Experience | Skills | Telecommute | Sponsor Visa |
---|---|---|---|---|---|---|---|
Immediate | 29 Nov, 2024 | Not Specified | 02 Sep, 2024 | 1 year(s) or above | Trend Analysis,Chemistry,Technical Writing,Root Cause Analysis,Biochemistry,Writing,Communication Skills,Biology | No | No |
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Description:
DEVIATION INVESTIGATION WRITER II
Thermo Fisher Scientific Inc. is seeking a motivated and ambitious Deviation Investigation Writer II to join our world-class Manufacturing team in St. Louis. As a Deviation Investigation Writer, you will play a crucial role in ensuring the successful execution of our operations by investigating and analyzing deviations or non-conformances that arise in various aspects of our company’s operations, including Manufacturing, Quality Control, and Facilities.
EDUCATION:
- BS/BA in biology, biochemistry, chemistry, or other science-related field.
EXPERIENCE:
- 1+ years of experience in direct utilization of problem-solving tools (Root Cause Analysis and/or LEAN/six sigma experience) with demonstrated success.
- 1+ years of experience in technical writing and/or deviation writing.
- 3+ years of experience working in a regulated environment, preferably in biologics/pharmaceuticals.
KNOWLEDGE, SKILLS, AND ABILITIES:
- Solid technical writing and communication skills.
- Ability to evaluate data and make recommendations based on trends and trend analysis.
- Ability to work effectively in a fast-paced environment and prioritize tasks.
- Ability to facilitate meetings for desired outcomes.
Responsibilities:
- Analyze and investigate deviations or non-conformances, using problem-solving tools like root cause analysis.
- Collect relevant data and information related to the deviation, and analyze it to identify patterns, trends, or potential causes.
- Document findings in a comprehensive and objective manner, ensuring accurate recording of all relevant information.
- Collaborate with various departments to gather information, evaluate causal factors, and implement corrective and preventive actions (CAPAs).
- Provide timely written documentation of investigations and communicate recommendations based on investigation outcomes.
- Participate in client communications and responses, working closely with program team leads, quality, and management.
REQUIREMENT SUMMARY
Min:1.0Max:3.0 year(s)
Information Technology/IT
Pharma / Biotech / Healthcare / Medical / R&D
Content, Journalism
Graduate
Proficient
1
St. Louis, MO 63134, USA