QA Operations Specialist - Biopharmaceutical Manufacturing chez SOKOL GxP Services

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