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Job type: Contract

Discipline: Good Manufacturing Practice (GMP)

Location: United States

QA Associate - Contract - Philadelphia, PA

Ensure GMP excellence by owning the accuracy, integrity, and compliance of critical quality documentation.

Proclinical is seeking a QA Associate - Doc Control to support quality assurance activities in a GMP-regulated biopharmaceutical environment.

Primary Responsibilities:

The successful candidate will focus on ensuring compliance with procedures and standards while contributing to quality improvement initiatives.

Skills & Requirements:

Bachelor's degree in science or engineering, or equivalent experience.
Relevant experience in a GMP-regulated biopharmaceutical environment.
Working knowledge of GMP regulations (US, EU, ROW), GDP, 21 CFR, USP, and applicable standards.
Strong attention to detail and effective written and verbal communication skills.
Ability to work independently, manage multiple priorities, and perform under pressure.

The QA Associate's responsibilities will be:

Provide on-floor QA support during GMP manufacturing to ensure compliance with procedures and cGMP standards.
Monitor manufacturing operations and facility conditions to maintain a compliant environment.
Escalate quality issues promptly and support real-time troubleshooting.
Review batch records, logbooks, and GMP documentation for completeness and accuracy to support timely disposition.
Review incoming material disposition packets and verify documentation completeness.
Support data review, trending, and identification of quality risks.
Perform QA review of SOPs, forms, protocols, and other controlled documents.
Contribute to quality improvement, lean initiatives, and process efficiency projects.
Assist across Quality functions, including document control, training, audits, and systems.
Communicate effectively with cross-functional teams and uphold company quality standards and policies.

If you are having difficulty in applying or if you have any questions, please contact Anderson Maldonado at a.maldonado@proclinical.com.

If you are interested in applying to this exciting opportunity, then please click 'Apply' or to speak to one of our specialists please request a call back at the top of this page.

Proclinical is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Proclinical is acting as an Employment Agency in relation to this vacancy.

By submitting this application, you confirm that you've read and understood our privacy policy, which informs you how we process and safeguard your data - https://www.proclinical.com/privacy-policy

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