Senior Data Review Specialist – Chemistry (LC-MS/MS Data Review)
Job Description
Position Summary: Ensure the client receives quality data in a timely manner by reviewing laboratory documentation, generated data, calculated results, and final reports for accuracy, clarity, and adherence to GMP and/or GLP regulations, and evaluating problems/system failures to achieve efficiency gains
Essential Duties and Responsibilities:
- Applies GMP/GLP in all areas of responsibility, as appropriate
- Demonstrate and promote the company vision
- Regular attendance and punctuality
- Review simple and complex routine and non-routine data (for 3 or more areas) according to departmental, corporate, and client SOPs; read and understand analytical procedures; make sure all work is performed according to GLP/GMP requirements; perform complex calculations
- Communication in writing and in person with laboratory personnel in an intelligent and clear manner
- Exercise discretion and independent judgment with respect to matters of significance directly related to the management or general business operations through the data review process
- Perform review of scientific data, including, but not limited to standard preparation, calibrations, methodology, QC, sample data, integration review, compound evaluation, and other subjective review based on testing performed; perform complex calculations to verify results
- Verify the data is of sound quality and determine if data is compliant and defendable based on industry regulations and methodology
- May serve as technical advisor for analysts with regard to QA/QC of data
- Diagnose problems; solve simple problems, and suggest solution to complete problems in professional area
- Keep oneself and peers abreast of current developments and trends in professional area by reading and understanding internal procedures, attending/providing training sessions, by writing/revising SOPs (as required), and by assisting Group Leader / Principal Specialists in training new and existing employees
- Use MS Windows applications such as Excel, Word, Access, Outlook email; create complex Excel worksheets and formulas
- Communicate with internal clients to discuss any findings and notify them of any necessary rework or compliance/regulatory concerns
- Conducts all activities in a safe and efficient manner
- Performs other duties as assigned