GMP QA Specialist I – Onsite, 12‑Hour Rotations

Actalent; Plainville (CT); On-site; USD 34,000 - 55,000; Full time

Benefits offered by this job

Medical, dental & vision

401(k) Retirement Plan

Life Insurance

Short and long-term disability

Job summary

Actalent is seeking a Quality Assurance Specialist I in Plainville, MA to ensure GMP manufacturing operations and quality systems meet SOPs and regulatory requirements. You will oversee on-the-floor QA activities, review critical GMP documents, and support CAPAs, deviations, investigations, and change controls to maintain strong quality culture.

The role requires collaboration with Manufacturing and Quality Control, strong attention to detail, and the ability to work in a regulated environment.

Qualifications

• GMP knowledge and regulatory awareness required for daily QA oversight.
• Experience reviewing batch records and GMP documentation for accuracy.
• Familiarity with CAPA, deviations and change controls in a GMP environment.
• Ability to identify and elevate quality events and risks in a timely manner.
• Experience supporting internal and client audits and inspections.

Responsibilities

• Perform on-the-floor QA oversight of GMP manufacturing operations and ensure adherence to procedures.
• Review batch records and GMP documentation for accuracy and completeness.
• Support investigations, deviations, CAPAs, and change controls under senior QA guidance.
• Identify, document, and elevate compliance risks and quality events promptly.
• Collaborate with Manufacturing, Quality Control, and support functions to ensure QA alignment.
• Assist with internal and client audits and inspection readiness activities as needed.
• Maintain up-to-date knowledge of GMP regs and site procedures to apply in daily tasks.

Skills

GMP knowledge

Documentation

CAPA systems

Change controls

Investigations

Regulatory awareness

Audit support

Quality events management

Education

Bachelor degree in Life Sciences or related field

Job description

Actalent is seeking a Quality Assurance Specialist I in Plainville, MA to ensure GMP manufacturing operations and quality systems meet SOPs and regulatory requirements. You will oversee on-the-floor QA activities, review critical GMP documents, and support CAPAs, deviations, investigations, and change controls to maintain strong quality culture.

The role requires collaboration with Manufacturing and Quality Control, strong attention to detail, and the ability to work in a regulated environment.