Associate Data Reviewer

Planet Pharma; Worcester (MA); On-site; USD 26,000 - 36,000; Full time

Job summary

Planet Pharma is seeking an Associate Data Reviewer to join the data review team in a fast-paced GMP environment. The role includes archiving data, performing routine reviews of lab data, and supporting administrative tasks such as logbook management.

Ideal candidates have a Bachelor’s Degree or 5+ years in pharma manufacturing/QA, with strong GMP knowledge and time-management skills to meet deadlines and maintain data integrity.

Qualifications

• Bachelor’s Degree or 5+ years of pharma manufacturing/QA experience.
• Familiarity with GMP and lab-record requirements.
• Strong attention to detail and data integrity.

Responsibilities

• Archiving data in the RIMS system.
• Performs routine review of lab test data.
• Supports logbook management and data filing.
• Participates in training activities as needed.

Skills

Data review

GMP knowledge

Time management

Administrative support

Education

Bachelor’s Degree

High School Diploma with 5+ years experience

Tools

RIMS system

Data archiving tools

Job description

Target PR Range: 19-26/hr DOE
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

• 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