Pharmaceutical Data Review Scientist

The Role

The Pharmaceutical Data Review Scientist will be responsible for ensuring that client-received data is accurate, clear, and adheres to Good Manufacturing Practices (GMP) and Good Laboratory Practices (GLP).

Responsibilities

• Review laboratory data for accuracy, clarity, and compliance with GMP and GLP regulations
• Review routine and non-routine data for three or more areas according to departmental, corporate, and client Standard Operating Procedures (SOPs)
• Read and understand analytical procedures; ensure all work is performed according to GLP/GMP requirements
• Determine if data is compliant and defendable based on industry regulations and methodology
• Verify data quality following all method, industry, and client requirements
• Diagnose and solve problems, including troubleshooting method and instrumentation issues
• Use office and instrumentation-specific computer software
• Produce written reports such as Standard Operating Procedures (SOP), Observational Monitoring Certificates (OMC), and client reports

Requirements

• 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

Qualifications

• 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

Benefits

• Comprehensive medical coverage, dental, and vision options
• Life and disability insurance
• 401(k) with company match
• Paid vacation and holidays