Data Reviewer at Thermo Fisher Scientific in High Point, North Carolina

Job Description:

Work Schedule

First Shift (Days)



Environmental Conditions

Laboratory Setting, Office



Job Description




SUMMARY OF POSITION



The role of QA Data Reviewer is to support our Laboratory teams in ensuring the integrity and quality of laboratory and chromatographic data and reports. Ensures analyses are following validated or experimental analytical procedures, and compare results to methodology, protocol and product specifications, Standard Operating Procedures (SOPs) acceptance criteria, and Good Manufacturing Practices (GMP). Reviews data entered into databases and reports and monitors the quality of the laboratory data. This 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 data, related notebooks and sample results for scientific soundness, completeness, accurate representation 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 or reports 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 in conversations with laboratory staff on best documentation practices and addressing quality findings.

• Advocates for quality and review process changes.

• Identifies and 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 procedures, methodology and 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

KEY QUALIFICATIONS

• Compendial experience (USP, EP) is a plus.


• Chromatography experience is a must.


• Self-motivated and able to work independently.


• Well-rounded laboratory experience, with a focus on analytical work.

WORK ENVIRONMENT



Thermo Fisher 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 with proficiency.

• 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.

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