QA Auditor II Onsite

Our client, Quality & Compliance in the pharmaceutical R&D space is seeking a QA Auditor II to join their team. As a QA Auditor II, you will be part of the Quality R&D Third Party organization supporting third-party quality oversight for GMP manufacturing activities. The ideal candidate will have strong attention to detail, the ability to make risk-based quality decisions, and the confidence to communicate clearly with internal and external stakeholders.

Job Title:

QA Auditor II

Location:

Collegeville, PA Pay Range: $30 -$35/hr

• Serve as a primary quality contact for assigned third parties and projects, partnering with internal stakeholders involved in contracted activities.
• Monitor and support third-party quality performance and compliance with applicable GSK standards, quality requirements, cGMP expectations, regulatory requirements, and quality agreements.
• Coordinate and support quality governance meetings with third parties, including preparation of quality performance information, documentation of actions, and follow-up to closure.
• Review and assess third-party quality management system records, including deviations, complaints, change controls, CAPAs, investigations, and validation-related documentation, ensuring timely follow-up in line with cGMP and quality agreements.
• Identify, assess, document, communicate, mitigate, and escalate quality issues and risks through appropriate quality governance pathways.

• Bachelor's degree in Pharmacy, Science, Engineering, or a related discipline, or an equivalent level of knowledge, understanding, and hands-on GMP experience in the pharmaceutical environment.
• At least 5 years of pharmaceutical manufacturing and/or quality experience.
• Practical knowledge of cGMP principles and regulatory expectations applicable to pharmaceutical development and manufacturing.
• Experience reviewing or approving GMP manufacturing, laboratory, batch, validation, and/or quality system documentation.
• Experience supporting or leading quality system activities such as deviations, investigations, complaints, change controls, CAPAs, inspections, audits, and root-cause analysis.

• Opportunity to apply third-party quality management expertise in a cross-functional R&D environment.
• Meaningful impact on ensuring contracted services and batch documentation meet GMP, regulatory, and quality agreement requirements.
• Exposure to quality governance, supplier qualification support, and audit planning and follow-up activities.
• Chance to strengthen quality decision-making through risk-based escalation and issue mitigation.
• Support and guidance opportunities through training, education, and quality advice to business partners and third parties.

Upon completion of waiting period consultants are eligible for:

• Medical and Prescription Drug Plans
• Dental Plan
• Vision Plan
• Health Savings Account
• Health Flexible Spending Account
• Dependent Care Flexible Spending Account
• Supplemental Life Insurance
• Short Term and Long Term Disability Insurance
• Business Travel Insurance
• 401(k), Plus Match Weekly Pay