Field Specialist QA Operations

Job Description: Field QA Specialist

Devens, MA

This role is 100% Onsite

Work Schedule: Mon - Fri, 2PM - 10PM EST

JOB SUMMARY

*** is seeking a Contractor Field QA Specialist for the QA Operations organization at the Single Use Facility (SUF) in Devens, MA. The Contractor Field QA Specialist is responsible for quality activities for the Single Use Facility in accordance with Client policies, standards, procedures, and Global cGMP. Functional responsibilities include ensuring manufacturing compliance with applicable procedures and batch records, providing real time review of manufacturing batch record documentation and logbooks, and working with operations to resolve manufacturing issues. The Contractor Field QA Specialist role is stationed in Devens, MA and reports to the Senior Manager of QA Operations for the Devens SUF.

JOB RESPONSIBILITIES

Perform QA on the floor activities.

Ensure manufacturing compliance with applicable procedures and batch records.

Perform real time review of manufacturing batch records.

Review manufacturing shop floor documentation.

EDUCATION REQUIREMENTS

High School Degree required

Relevant college or university degree preferred.

Minimum 4 years relevant work experience, with experience in a Quality Assurance role.
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