Data Reviewer - Lab Support Group


    Job Description

    How will you make an impact?

    Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue exceeding $25 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, improving patient diagnostics and therapies or increasing productivity in their laboratories, we are here to support them. Our global team of more than 75,000 colleagues delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services and Patheon. For more information, please visit www.thermofisher.com.

    Summary:

    Provides support for analytical data review, instrument qualification, and computer systems in a fast-paced GMP laboratory environment. Authors Standard Operating Procedures, Deviation/ Discrepancy Reports, Change Controls, Corrective and Preventive Actions, Risk Assessments, Validation Protocols, and Summary Reports. Initiates Commissioning and Decommissioning procedures. Supports continuous improvement initiatives while maintaining quality.

    Responsibilities:
    • Critically reviews testing from the following instrumentation: HPLC, GC, PXRD, Dissolution, DSC, FT-IR and KF.
    • Ensures analytical test results comply with internal specifications as well as company and regulatory standards.
    • Collaborates with internal scientific, analytical, laboratory and quality functional areas to meet project and team objectives.
    • May interact with customers, vendors, and auditors.
    • Maintains and troubleshoots analytical instrumentation.
    • Manages calibration and qualification schedule and manages instrument qualification status.
    • Researches, purchases, and commissions new equipment.
    • Decommissions retired equipment.
    • Coordinates with vendors/ manufacturers for on-site or external service, sends equipment out for maintenance, and reviews external documentation.
    • Prepares, executes, and reviews analytical instrument qualifications.
    • Supports qualified computer systems by reviewing qualification documents, audit trails, and user reviews. More extensive involvement depending on experience.
    • Performs all duties in strict compliance with Standard Operating Procedures, Good Manufacturing Practices, and safety guidelines.
    • Maintains the necessary compliance status required by company and facility standards.
    Education & Experience
    • Bachelor's of Science in Chemistry, Biochemistry, Biology, Computer, or related science.
    • Typically requires no previous related experience.
    • Experience performing or reviewing chemical tests with chromatographic, spectroscopic, or other analytical technique preferred.
    • Some lab experience preferred (0-2 years).
    • Experience with computer systems and/ or analytical instrument qualification preferred.
    • Equivalent combinations of education, training, and relevant work experience may be considered.
    • Excellent critical and logical thinking skills to solve problems.
    • Effective verbal and written communication skills.
    • Ability to work on multiple tasks simultaneously.
    • Experience with Microsoft Excel and Word.
    • Good knowledge of qualitative and quantitative chemical analysis as it relates to the pharmaceutical industry.
    • Understanding of GMP and data integrity (ALCOA) is preferred.
    • Ability to read, analyze, and interpret technical procedures and governmental regulations.
    • Ability to write standard operating procedures, protocols, and reports.
    If you are an individual with a disability who requires reasonable accommodation to complete any part of our application process, click here for further assistance.

    Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.

    Posting ID: 558255802Posted: 2020-05-21