QA Operations Specialist at LSCC

Compensation

$50 – $58/hr

Location: Harvard, Massachusetts
Type: Contract
Posted: Jan 23, 2026

Description

The QA Operations Specialist will provide on-the-floor Quality Assurance support within a biopharmaceutical manufacturing setting at the LSCC site in Devens, MA. This role involves reviewing manufacturing batch records, ensuring compliance with company policies and global cGMP requirements, and assisting with quality decision-making in a regulated GMP environment. The specialist will identify and escalate quality issues, support investigation and improvement efforts, and contribute to procedure development.

Required Skills

Batch Record Review
Documentation Skills
Quality Decision-Making
Compliance
Documentation Skills
Cross-functional Collaboration
Authorship Skills
Quality Risk Management Principles
cGMP Requirements
GMP Operations
Quality Processes
Independent Judgment
Decision Making
Communication Skills
Organizational Skills

Additional Information

Required Previous Experiences: 4 years of relevant Quality Assurance experience in an FDA-regulated cGMP environment.
manufacturing shop floor documentation experience.
Preferred Qualifications: Experience supporting GMP manufacturing and/or warehousing operations.
Working knowledge of quality processes including deviations, investigations, change control, material disposition, product complaints, and CAPA management.
Ability to work independently with moderate direction on complex tasks.
Confidence in making decisions for non-routine quality issues.
Strong written and verbal communication skills.
Strong organizational skills with the ability to multitask in a fast-paced manufacturing environment.