Quality Assurance Specialist, GMP & Batch Records

Actalent; Fort Dodge (IA); Presencial; USD 41 000 - 48 000; Tempo integral

Vantagens oferecidas por esta oferta de emprego

Medical, dental & vision

401(k) Retirement Plan

Life Insurance

Short and long-term disability

Paid time off (PTO)

Resumo da oferta

Actalent is seeking a Quality Associate in Fort Dodge, IA to join the QA Release Group and Process Team. You will review batch records and related technical docs to ensure regulatory compliance with USDA, FDA, and EU standards, while providing real-time QA guidance to production staff.

The role requires 1–2 years in a GMP-regulated environment and hands-on experience with batch records, SOPs, and quality investigations. It’s a contract-to-hire, onsite position offering 40 hours per week.

Qualificações

• Bachelor's degree in a scientific discipline or equivalent experience.
• 1–2 years in a GMP-regulated environment (pharma or biologics).
• Experience reviewing GMP documents such as batch records, SOPs and investigations.
• Ability to work 8 hours per day, Monday–Friday in a 40-hour week.

Responsabilidades

• Review and approve batch records and related docs for production, validation and change control.
• Provide real-time QA support on the floor for batch reviews and process audits.
• Support deviation management, root cause analysis and investigation reporting.
• Assist with internal/external audits and track continuous improvement goals.
• Execute SAP release decisions and manage product movement and disposition.

Conhecimentos

Quality assurance

Batch record review

GMP documentation

Critical thinking

Self-driven

SOPs

Quality investigations

Microsoft Office

Formação académica

Bachelor's Degree in science

High School Diploma / GED + experience

Ferramentas

SAP

Veeva

Microsoft Office

Descrição da oferta de emprego

Actalent is seeking a Quality Associate in Fort Dodge, IA to join the QA Release Group and Process Team. You will review batch records and related technical docs to ensure regulatory compliance with USDA, FDA, and EU standards, while providing real-time QA guidance to production staff.

The role requires 1–2 years in a GMP-regulated environment and hands-on experience with batch records, SOPs, and quality investigations. It’s a contract-to-hire, onsite position offering 40 hours per week.