Pharmaceutical Data Review Scientist
About The Position
Ensure that the client receives quality data by reviewing laboratory data for accuracy, clarity, and adherence to GMP and/or GLP regulations. Review simple and complex routine and non-routine data (for three or more areas) according to departmental, corporate, and client SOPs; read and understand analytical procedures; ensure all work is performed according to GLP/GMP requirements and apply GLP/GMP in all areas of responsibility as appropriate. Perform analysis of proteins and the impurities or raw materials associated with their production using various analytical techniques. Determine if data is compliant and defendable based on industry regulations and methodology. Verify data is of sound quality following all method, industry, and client requirements where applicable. Diagnose problems, solve simple problems, and suggest solutions to complex problems in professional area; perform complex calculations. Troubleshoot method and instrumentation problems. Use office and instrumentation specific computer software. Produce written reports (e.g., SOP, OMC, client reports).
Requirements
- Bachelor's degree in chemistry or other related degree concentration, or equivalent directly-related experience
- Authorization to work in the United States indefinitely without restriction or sponsorship
- Strong computer, scientific, and organizational skills
- Excellent communication (oral and written) and attention to detail
- Ability to work independently and as part of a team, self-motivation, adaptability, and a positive attitude
- Ability to learn new techniques, perform multiple tasks simultaneously, keep accurate records, follow instructions, and comply with company policies
Responsibilities
- Review laboratory data for accuracy, clarity, and adherence to GMP and/or GLP regulations
- Review simple and complex routine and non-routine data (for three or more areas) according to departmental, corporate, and client SOPs
- Read and understand analytical procedures
- Ensure all work is performed according to GLP/GMP requirements and apply GLP/GMP in all areas of responsibility as appropriate
- Perform analysis of proteins and the impurities or raw materials associated with their production using various analytical techniques
- Determine if data is compliant and defendable based on industry regulations and methodology
- Verify data is of sound quality following all method, industry, and client requirements where applicable
- Diagnose problems, solve simple problems, and suggest solutions to complex problems in professional area
- Perform complex calculations
- Troubleshoot method and instrumentation problems
- Use office and instrumentation specific computer software
- Produce written reports (e.g., SOP, OMC, client reports)
Benefits
- Comprehensive medical coverage
- dental
- vision options
- Life and disability insurance
- 401(k) with company match
- Paid vacation and holidays
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
