GMP QA Specialist I – Onsite Quality Oversight

ACTalent; Plainville (MA); Presencial; USD 39.000 - 41.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Medical, dental & vision

401(k) Retirement Plan

PTO / Vacation

Descripción de la vacante

Actalent in Plainville, MA is seeking a Quality Assurance Specialist I to ensure GMP operations and quality systems meet SOPs and regulatory standards. You will provide on-the-floor QA oversight and support CAPA, deviations, and change controls with meticulous documentation.

The role requires a Bachelor’s in Life Sciences and 1+ year GMP experience, plus strong communication and collaboration across Manufacturing and QA. On-site contract role with potential audits involvement.

Formación

• Bachelor’s degree in Life Sciences or related field.
• 1+ year GMP industry experience.
• Knowledge of FDA/EMA GMP regulations.
• Attention to detail for GMP documentation.
• Strong written and verbal communication.
• Proficiency with MS Office and electronic quality systems.

Responsabilidades

• Provide on-the-floor QA oversight of GMP operations.
• Review batch records for accuracy and compliance.
• Support investigations, deviations, CAPAs, and change controls.
• Escalate quality risks in a timely manner.
• Collaborate with Manufacturing and QA to ensure SOP adherence.
• Assist during internal and client audits and inspections.

Conocimientos

GMP experience

Batch records

CAPA systems

Deviations

Change controls

Regulatory knowledge

Educación

B.S. Life Sciences

Descripción del empleo

Actalent in Plainville, MA is seeking a Quality Assurance Specialist I to ensure GMP operations and quality systems meet SOPs and regulatory standards. You will provide on-the-floor QA oversight and support CAPA, deviations, and change controls with meticulous documentation.

The role requires a Bachelor’s in Life Sciences and 1+ year GMP experience, plus strong communication and collaboration across Manufacturing and QA. On-site contract role with potential audits involvement.