Validation Analyst III: GMP Compliance & Projects

PCI TRGR Penn Pharmaceutical Services Ltd; Illinois; Presencial; USD 37 000 - 43 000; Tempo integral

Vantagens oferecidas por esta oferta de emprego

Paid time off

Health insurance (including dental and

Vision

401(k) plan

Resumo da oferta

PCI Pharma Services is seeking a Validation Analyst III for the 2nd shift, offering an additional 10% shift premium. The role oversees validation project management for large customer accounts, prepares protocols and validation plans, and coordinates approvals across multiple sites to ensure quality and compliance.

You will support customer audits and drive corrective actions when deviations occur. The position requires an Associate's Degree with 1–3 years of related experience, strong

Qualificações

• Associate's Degree in a related field and/or 1–3 years related experience.
• Strong mathematical and analytical abilities.
• Proficient in computer applications and software tools.
• Excellent written and verbal communication; ability to work under minimal supervision.

Responsabilidades

• Manage validation activities to meet government and customer requirements.
• Prepare validation protocols, statements, and master validation plans for new launches and maintain existing validated processes across sites.
• Coordinate internal and customer approvals and document closure of validation packages.
• Attend customer meetings and effectively communicate goals and progress to leadership.
• Investigate deviations and document corrective actions to complete projects.
• Serve as customer contact for quality validation activities and manage expectations.
• Review standards and specifications to ensure alignment with validation protocols.
• Ensure production documents meet internal standards and procedures.

Conhecimentos

Math skills

Computer proficiency

Oral and written communication

Problem solving

Follow instructions

Time management

Decision making

Audit readiness

Formação académica

Associate's Degree in related field

Ferramentas

None

Descrição da oferta de emprego

PCI Pharma Services is seeking a Validation Analyst III for the 2nd shift, offering an additional 10% shift premium. The role oversees validation project management for large customer accounts, prepares protocols and validation plans, and coordinates approvals across multiple sites to ensure quality and compliance.

You will support customer audits and drive corrective actions when deviations occur. The position requires an Associate's Degree with 1–3 years of related experience, strong