Associate Data Reviewer

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

Job summary

Planet Pharma in Worcester, MA is seeking an Associate Data Reviewer to support the data review team in a fast-paced GMP environment. You will review assays, perform data mining, and archive records to ensure data integrity and timely completion of tasks.

This role requires a degree or equivalent experience, knowledge of GMP, and the ability to manage multiple tasks such as logbook control and scanning of data.

Qualifications

• Bachelor’s degree or high school diploma with 5+ years in pharma/biologics QA/QC.
• Experience in GMP environments and data review is preferred.
• Familiarity with RIMS or similar data archival systems is a plus.

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.
• Accepts responsibility to complete assigned tasks as committed. Works with others 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.

Skills

Data review

Documentation

Time management

Team collaboration

Education

Bachelor’s Degree

High School Diploma with 5+ years experience in pharma/biologics QA/QC

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