Work Schedule
First Shift (Days)
Environmental Conditions
Adherence to all Good Manufacturing Practices (GMP) Safety Standards Laboratory Setting Office
Job Description
SUMMARY OF POSITION
The role ofQAData Reviewer is to support our Laboratory teams in ensuring the integrity and quality of laboratory and chromatographic data and analyses are following validated or experimental analytical procedures and compare results tomethodology protocol and product specifications Standard Operating Procedures (SOPs) acceptancecriteria and Good Manufacturing Practices (GMP). Reviews dataentered intodatabases and reports andmonitorsthe quality of the laboratory job is ideal for someone who has strong review experience and is looking to move away from hands on lab duties.
A day in the Life
- Ensures the quality of laboratory data and reports.
- Reviews chromatographic datarelated notebooksandsample results for scientific soundness completenessaccuraterepresentation of the data and final reported results.
- Evaluates data to ensure compliance with analytical methods client criteria Good Laboratory Practices (GLP) and Good Manufacturing Practices (GMP).
- Delivers review findings noting deficiencies within the analytical data orreports in a clear and concise manner
- Communicates with laboratory staff to proactively address the quality of laboratory documentation.
- Reports deficiencies to laboratory staff for correction.
- Facilitates inconversations with laboratory staff on best documentation practicesand addressing quality findings.
- Advocates for quality and review process changes.
- Identifiesand supports process improvement initiatives.
EDUCATION AND EXPERIENCE
- Bachelor of Science Degree in Chemistry Microbiology Biology Biochemistry or related field with 5 years of related experience in an analytical laboratory setting preferably in a Quality Control or Analytical Development Laboratory in a GMP facility.
- Thorough knowledge of SOPs and Federal Regulations to include GLP and GMP
- Strong verbal and written communication skills
- Strong technical knowledge including an understanding of laboratory proceduresmethodologyand standards
- Ability to independently review laboratory reports and analytical methods
- Strong attention to detail
- Ability to provide clear and concise feedback and/or documentation of results
WORK ENVIRONMENT
ThermoFisher Scientific values the health and wellbeing of our employees. We support and encourage individuals to create a healthy and balanced environment where they can thrive. Below is listed the working environment/requirements for this role:
- Able to communicate receive and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner.
- Able to work upright and stationary and/or standing for typical working hours.
- Able to work in non-traditional work environments.
- Able to use and learn standard office equipment and technology withproficiency.
- May have exposure to potentially hazardous elements typically found in laboratory environments.
- Able to perform successfully under pressure while prioritizing and handling multiple projects or activities.