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

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:

• 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

If this is a role that interests you and you'd like to learn more, click apply now and a recruiter will be in touch with you to discuss this great opportunity. We look forward to speaking with you!

About ManpowerGroup, Parent Company of: Manpower, Experis, Talent Solutions, and Jefferson Wells.

ManpowerGroup® (NYSE: MAN), the leading global workforce solutions company, helps organizations transform in a fast-changing world of work by sourcing, assessing, developing, and managing the talent that enables them to win. We develop innovative solutions for hundreds of thousands of organizations every year, providing them with skilled talent while finding meaningful, sustainable employment for millions of people across a wide range of industries and skills. Our expert family of brands – Manpower, Experis, Talent Solutions, and Jefferson Wells – creates substantial value for candidates and clients across more than 75 countries and territories and has done so for over 70 years. We are recognized consistently for our diversity - as a best place to work for Women, Inclusion, Equality and Disability and in 2023 ManpowerGroup was named one of the World's Most Ethical Companies for the 14th year - all confirming our position as the brand of choice for in-demand talent.