GMP Quality Assurance Specialist I

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

Benefits offered by this job

Medical, dental & vision

401(k) Retirement Plan

Life Insurance

PTO / Vacation

Transportation benefits

Health Spending Account (HSA)

Employee Assistance Program

Job summary

Actalent is seeking a Quality Specialist I for our Plainville, MA site. You will provide on-the-floor QA oversight of GMP manufacturing and review batch records for compliance and accuracy.

The role supports CAPAs, deviations, and change controls under QA guidance, partnering with manufacturing and QC to ensure adherence to SOPs and quality systems. Strong communication and GMP knowledge are essential.

Qualifications

• Minimum 1+ years of GMP industry-related experience with a Bachelors Degree in Life Sciences or Chemical/Biochemical Engineering.
• Working knowledge of FDA, EMA, and applicable GMP regulations.
• Support CAPA systems, change controls, risk management, and quality oversight.
• Understanding of GMP manufacturing operations and quality systems.
• Ability to review GMP documentation with attention to detail.
• Basic knowledge of deviations, CAPAs, investigations, and change control processes.
• Strong written and verbal communication skills.
• Effective organizational, time management, and problem-solving abilities.

Responsibilities

• Perform on-the-floor Quality Assurance oversight of GMP manufacturing operations.
• Review executed batch records and GMP documentation for accuracy, completeness, and compliance.
• Support investigations, deviations, CAPAs, and change controls under guidance from QA staff.
• Escalate quality events, compliance risks, and atypical observations in a timely manner.
• Partner with Manufacturing, QC, and support functions to ensure adherence to approved procedures.
• Support internal audits, client audits, and inspection readiness activities.
• Maintain knowledge of applicable GMP regulations, site procedures, and quality systems.

Skills

GMP experience

Documentation review

CAPA knowledge

Quality oversight

Regulatory knowledge

Attention to detail

Education

Bachelor's degree in Life Sciences or Chemical/Biochemical Engineering

Tools

Electronic quality systems

MS Office

Job description

Actalent is seeking a Quality Specialist I for our Plainville, MA site. You will provide on-the-floor QA oversight of GMP manufacturing and review batch records for compliance and accuracy.

The role supports CAPAs, deviations, and change controls under QA guidance, partnering with manufacturing and QC to ensure adherence to SOPs and quality systems. Strong communication and GMP knowledge are essential.