Associate Data Reviewer

Synectics Inc.; Worcester (MA); On-site; USD 55,000 - 75,000; Full time

Benefits offered by this job

Healthcare Insurance

Dental Insurance

Vision Insurance

401(k) Plan

Job summary

Synectics Inc. is seeking an Associate Data Reviewer to support the data review team in a fast-paced GMP environment. The role focuses on reviewing lab data across multiple areas, archiving data in RIMS, and assisting with administrative tasks and training.

Responsibilities include routine data reviews for low-complexity methods, data archiving, logbook management, and filing. Onsite schedule is Sunday to Thursday from 2 PM to 10:30 PM.

Qualifications

• Bachelor's Degree or equivalent experience.
• High School Diploma with 5+ years in manufacturing, QA, QC in pharmaceutical or biologics.
• Strong organizational and time management skills.
• Experience with RIMS, Empower, A280.
• Onsite schedule: Sunday–Thursday, 2:00 PM–10:30 PM.

Responsibilities

• Review lab data and perform On-the-Floor and Off-the-Floor reviews for low complexity methods.
• Archive data in the RIMS system.
• Support data review team in GMP environment across multiple areas (raw materials to validation).
• Assist with logbook management and scanning/filing of data.
• Participate in training of other employees as needed.

Skills

Organizational skills

Time management

Education

Bachelor's Degree

High School Diploma with 5+ years in pharma/biologics

Tools

RIMS

Empower

A280

Job description

Description

• 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
• 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.
• Understand 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
• Organizational skills
• Time management
• Experience with RIMS, Empower, A280
• Schedule: Onsite Sunday-Thursday, 2pm-10:30pm

Benefits

• Healthcare Insurance: Synectics offers eligible employees and their dependents healthcare coverage through BlueCross BlueShield of Illinois. Eligibility begins on the 1st day of the calendar month following 60 days of continuous full time employment with Synectics. Premiums are subsidized by Synectics.
• Dental Insurance: Synectics offers eligible employees and their dependents a dental plan through MetLife. Eligibility begins on the 1st day of the calendar month following 60 days of continuous full time employment with Synectics.
• Vision Insurance: Synectics offers eligible employees vision insurance through VSP. Eligibility begins on the 1st day of the calendar month following 60 days of continuous full time employment with Synectics.
• 401(k) Plan: The Synectics Inc. Investment Savings Retirement Plan. Synectics offers all employees who are 21 years of age or older the opportunity to invest in the 401(k) Plan on the first of the month following at least 1 calendar year after employment begins.

Synectics is an equal opportunity employer.