QC Data Reviewer (Analytical/Chemistry)

What are the top 3-5 skills, experience or education required for this position:

• Organizational skills
• Time management
• Bachelors degree or equivalent
• Experience with RIMS, Empower, A280

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

Major Responsibilities:

List up to 10 main responsibilities for the job. Include information about the accountability and scope.

• 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:

List required and preferred qualifications (up to 10). Include education, skills and experience.

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