Associate Data Reviewer

The Associate Data Reviewer supports the data review team within a fast paced GMP environment in support of one or more of the following areas; raw material, environmental monitoring, in-process, final bulk, stability or validation. The coordinator will complete review of assays, data mining projects, and archiving of data. Works under the guidance of a supervisor but is able to manage time efficiently in achieving timely completion of assigned duties.

SHIFT: Sunday-Thursday, 2pm-10:30pm

Major Responsibilities:

• • Archiving of data in the RIMS system
• • Performs Routine Review of Lab test data including On-the-Floor Review, and Off-the-Floor Review for low complexity test methods.
• • Understands and maintains a safe work environment for themselves and others in accordance with procedural requirements
• • Understand, implements and maintains GMP with respect to laboratory records, procedures and systems in accordance with procedural requirements
• • Accepts responsibility to complete assigned tasks as committed. Works with other to maintain a positive atmosphere to accomplish business objectives
• • Supports the review team with administrative tasks such as logbook management and scanning/filing of data.
• • Participates in training of other employees, but focused on demonstration and not management of training delivery

Qualifications:

• Bachelor’s Degree OR High School Diploma with 5+ years of combined experience in manufacturing, QA, QC in pharmaceutical or biologics industry

• What are the top 3-5 skills, experience or education required for this position:
• 1. organizational skills
• 2. time management
• 3. bachelors degree or equivalent
• 4. experience with RIMS, Empower, A280