QA Auditor II Onsite

Experis Technology Group; Collegeville (PA); On-site; USD 41,000 - 48,000; Full time

Benefits offered by this job

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

Job summary

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

Qualifications

• 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.

Responsibilities

• 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.

Education

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

Job description

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

What's the Job?

• 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.

What's Needed?

• 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.

What’s in it for me?

• 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:

Benefits

• 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