QA Operations Specialist - Biopharmaceutical Manufacturing
About The Position
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.
Requirements
- 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.
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
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
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Education Level
Associate degree
