The Data Reviewer will review technical data for compliance and accuracy. The reviewer will have strong attention to detail and be quality orientated. The reviewer will review raw data and final analytical reports from various standardized and custom analytical techniques and wet chemistry.
- Familiar with the concepts and data outputs of various analytical instrumentation including but not limited to GCMS, LCMS, ICP, SEM-EDS, DSC, FTIR, DLS, particle counts and wet chemistry.
- Reviews technical and electronic data for traceability, accuracy, and compliance to methods / standards, protocols and/or SOPS.
- Verifies raw data in laboratory notebooks, instrument/equipment usage logs, standard and reagent preparation logs to ensure accuracy and completeness of testing documentation.
- Performs verification of complex calculations via hand-calculations, computers, or validated spreadsheets.
- Participates in spreadsheet validation activities as needed.
- Reviews routine/standard and custom final analysis reports, and verifies the integrity and traceability of data reported.
- Manage work queue and prioritize to meet customer timelines.
- Interacts with study directors, project managers, quality control/quality assurance and technical staff as required.
- Able to navigate electronic systems (e.g. LIMS, environmental monitoring, Chromatographic Data Systems) to verify electronic data.
- Facilitates corrections with analysts to ensure all records are complete and accurate.
- Assist in SOP revisions as needed or required.
- Contributes to the overall operations and to the achievement of departmental goals.
- Perform job specific tasks in compliance with applicable Regulations, International Standards, and WuXi AppTec Policies and Standard Operating Procedures.
- Thorough understanding of Good Laboratory Practices and Good Manufacturing Practices.
- Leads or assists in audit readiness program.
- May participate in review of method development protocols and reports.
- Assist in education, guiding and influencing scientific staff in regards GDP best practices.
- Assist is collecting and trending RFT metrics and reporting feedback.
- Mentor and train new data reviewers/specialists.
- May be required to work Holidays and weekends.
- May be required to assist in other departments.
- Other duties as assigned.
Experience / Education
- Minimum 5 years of analytical laboratory and/or data review experience
- Minimum 1 year of review experience preferred
- Bachelor’s Degree or equivalent, preferably in Chemistry, Biochemistry
- Minimum 2 years’ experience working in a regulated environment
- Experience with Good Documentation Practices
- Life Science and/or Biotech experience
Knowledge / Skills / Abilities
- Strong organizational skills with attention to detail
- Proficient in Oral & Written communication skills
- Need to be able to read, write and understand English
- Proficient in Microsoft (Excel, Word, Outlook)
Physical Requirements
- Must be able to work in a Lab setting with exposure to animals/biohazards/chemical (list chemicals)
- Must be able to wear appropriate PPE
- Must be able to work in environment with minimal noise levels
- Ability to stand for long periods of time
- Clarity of vision
- Ability to identify and distinguish colors
- Must be able to perform activities with repetitive motions
- Ability to lift 25 lbs occasionally
- Ability to crouch, bend, twist and reach
- Inside working conditions
An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability
This job description does not state or imply that the above are the only duties and responsibilities assigned to this position. Employees holding this position will be required to perform any other job-related duties as requested by Management.
