GMP Quality Assurance Specialist I — Onsite

Actalent; Plainville (MA); On-site; USD 39,000 - 41,000; Full time

Benefits offered by this job

Medical, dental & vision

401(k) Retirement Plan

Paid time off

Job summary

Actalent is seeking a Quality Assurance Specialist I for a contract role in Plainville, MA. The candidate will ensure GMP manufacturing operations and quality systems comply with SOPs, regulatory requirements, and industry standards, performing on-the-floor QA oversight and reviewing critical GMP documentation.

The role requires 1+ year GMP experience, strong attention to detail, and collaboration with Manufacturing, Quality Control, and other teams to drive continuous improvement.

Qualifications

• Bachelor's degree in Life Sciences or related field required.
• 1+ year GMP industry experience.
• Familiarity with FDA/EMA GMP regulations.
• Ability to review GMP documentation with accuracy.
• Strong documentation and communication skills.

Responsibilities

• Provide on-the-floor QA oversight of GMP manufacturing.
• Review batch records and GMP docs for accuracy.
• Support investigations, deviations, CAPAs, and change controls.
• Elevate compliance risks and quality events promptly.
• Collaborate with Manufacturing and Quality Control to uphold procedures.
• Assist internal and client audits and inspections as needed.
• Maintain knowledge of GMP regulations and site procedures.
• Document quality activities using electronic QA systems.

Skills

GMP knowledge

Documentation review

CAPA & deviations

Regulatory compliance

On-the-floor QA

Microsoft Office

Attention to detail

Communication

Education

Bachelor's degree in Life Sciences or related field

Tools

Electronic quality systems

Job description

Actalent is seeking a Quality Assurance Specialist I for a contract role in Plainville, MA. The candidate will ensure GMP manufacturing operations and quality systems comply with SOPs, regulatory requirements, and industry standards, performing on-the-floor QA oversight and reviewing critical GMP documentation.

The role requires 1+ year GMP experience, strong attention to detail, and collaboration with Manufacturing, Quality Control, and other teams to drive continuous improvement.