# QA Operations Specialist - Biopharmaceutical Manufacturing

> SOKOL GxP Services · Devens, United States · Contract · Posted 2026-01-23

**Salary:** USD 104,000–120,224

**Workplace:** on_site

## Description

We are seeking a **QA Operations Specialist** to support Quality Assurance activities within a biopharmaceutical manufacturing environment at the LSCC site in Devens, MA. This role provides on-the-floor QA support to manufacturing operations, ensuring compliance with company policies, procedures, and global cGMP requirements.

The QA Operations Specialist performs real-time batch record review, reviews manufacturing shop floor documentation, and supports quality decision-making in a regulated GMP environment. The role requires independent judgment, strong documentation skills, and the ability to partner effectively with manufacturing and cross-functional teams.

This is an intermediate-level role requiring **4–7 years of relevant experience**.

**Work Schedule**  
This position follows a rotating two-week schedule with 12.5-hour shifts (5:00 AM – 5:30 PM):

Week 1  
• Work: Tuesday, Wednesday  
• Off: Thursday, Friday  
• Work: Saturday, Sunday, Monday

Week 2  
• Off: Tuesday, Wednesday  
• Work: Thursday, Friday  
• Off: Saturday, Sunday, Monday

The two-week rotation repeats continuously.  
Holidays are worked as business needs require.

**Key Responsibilities:**

-   Provide on-the-floor QA support to manufacturing operations;
-   Ensure compliance with approved procedures and batch records;
-   Perform real-time review of manufacturing batch records;
-   Review and approve shop-floor manufacturing documentation;
-   Identify, assess, and escalate quality issues as appropriate;
-   Support deviation investigations, change controls, and CAPA activities;
-   Apply Quality Risk Management principles in daily decision-making;
-   Partner cross-functionally to support continuous improvement initiatives;
-   Develop and revise GMP procedures as required.

## Requirements

**Must Haves:**

-   Required manufacturing shop floor documentation experience.
-   Strong authorship skills with the ability to critically review investigations, interpret results, and generate technical conclusions consistent with Quality Risk Management principles.

**Required Qualifications:**

-   Associate’s or Bachelor’s degree in a relevant discipline.
-   Minimum 4 years of relevant Quality Assurance experience in an FDA-regulated cGMP environment.
-   Strong knowledge of US and global cGMP requirements.
-   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.

## Benefits

Competitive hourly rate: **$50 – $57.8/hr (W-2 only, no C2C)**

12-month contract with possible extension

Health insurance, holiday pay, 401(k) program, and other benefits

Employee referral bonus program

## Apply

[Apply at SOKOL GxP Services](https://apply.workable.com/sokol-gxp-serivces/j/55680B19B9/apply)

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