QA Operations Specialist - Biopharmaceutical Manufacturing

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
.

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.

• 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

• 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

• 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

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