QA Auditor II: Third-Party GMP Compliance Lead

Experis Technology Group; Collegeville (PA); In loco; USD 41.000 - 48.000; Tempo pieno

Vantaggi offerti da questo lavoro

Medical and Prescription Drug Plans

Dental Plan

Vision Plan

Health Savings Account

Health Flexible Spending Account

Dependent Care Flexible Spending Area

Supplemental Life Insurance

Short Term and Long Term Disability

Business Travel Insurance

401(k) Plus Match Weekly Pay

Descrizione del lavoro

Quality & Compliance in the pharmaceutical R&D space is seeking a QA Auditor II to join their team in Collegeville, PA. The role focuses on third-party quality oversight for GMP manufacturing activities and requires strong attention to detail and risk-based decision making.

Collaboration with internal and external stakeholders is essential to ensure compliant batch documentation and quality agreements. The ideal candidate has a Bachelor's degree in a related discipline and at least 5 years

Competenze

• Bachelor's degree in Pharmacy, Science, Engineering, or a related discipline, or GMP experience in pharma.
• At least 5 years of pharmaceutical manufacturing or quality experience.
• Practical knowledge of cGMP principles and regulatory expectations.
• Experience reviewing GMP manufacturing, laboratory, batch, validation, and/or quality system documentation.
• Experience supporting quality systems such as deviations, investigations, complaints, CAPAs, audits.

Mansioni

• Serve as a primary quality contact for assigned third parties and projects.
• Monitor third-party quality performance and compliance with GMP standards.
• Coordinate and support quality governance meetings with third parties.
• Review third-party quality management system records and follow-up on deviations and investigations.
• Identify, assess, document, communicate, mitigate, and escalate quality issues through governance pathways.

Formazione

Bachelor's degree in Pharmacy, Science, Engineering, or related discipline

Descrizione del lavoro

Quality & Compliance in the pharmaceutical R&D space is seeking a QA Auditor II to join their team in Collegeville, PA. The role focuses on third-party quality oversight for GMP manufacturing activities and requires strong attention to detail and risk-based decision making.

Collaboration with internal and external stakeholders is essential to ensure compliant batch documentation and quality agreements. The ideal candidate has a Bachelor's degree in a related discipline and at least 5 years