Data Review Scientist I

Responsibilities include reviewing work for research and development under CGMP and/or GLP guidelines for studies, documentation, etc. Assisting in reviewing, monitoring and reporting studies to ensure data accuracy and report quality. Providing somewhat complex analytical review work on projects and studies using a knowledge of analytical techniques and instruments. Working with increasing independence on studies and assignments.

The ideal candidate would possess:

• Experience with GLP and/or GMP and knowledge of HPLC and/or GC.
• Experience with LIMS system desirable.
• Experience reviewing Empower.
• Familiarity and/or experience in a laboratory setting is required.
• Good organizational skills; ability to follow direction and good communication skills are required.
• 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.

Requirements

• Bachelor’s degree in relevant field such as chemistry, biochemistry, biology, chemical engineering, pharmaceutical sciences, or other directly related field or degree with comparable coursework in the above areas and a minimum of 6 months of experience in a directly relevant or demonstrated comparable competency and skill attainment is required.
• A Master’s degree in a relevant field may be substituted for the bachelor’s degree and experience.
• Authorization to work in the United States indefinitely without restriction or sponsorship.