Drive the quality systems that keep GMP operations compliant, efficient, and audit‑ready.

Proclinical is seeking a QA Systems Contractor to support Quality Operations and Quality Systems in the US.

Primary Responsibilities:

The successful candidate will focus on ensuring compliance with GMP standards, reviewing and approving critical documentation, and collaborating across teams to maintain quality standards. This position is ideal for someone with a strong background in Quality Assurance and a passion for contributing to efficient and compliant GMP operations.

Skills & Requirements:

• Bachelor's degree in science or engineering or equivalent experience.
• Relevant experience in Quality Assurance, Quality Systems, Quality Compliance, Quality Control, GMP manufacturing, and testing.
• Proficiency in leading Root Cause Analysis investigations, developing corrective actions, and performing risk assessments.
• Familiarity with early-phase to commercial quality systems development and maintenance.
• Knowledge of industry standards and regulatory requirements for biologics and small molecules in clinical development and commercialization.
• Understanding of GMP regulations, including US, EU, and ROW standards, good documentation practices, cGMP, 21 CFR Part 210 and 211, USP, and other applicable regulations.
• Ability to work in an office setting with occasional standing and computer usage.

The QA Systems Contractor's responsibilities will be:

• Review and approve analytical method qualification protocols, reports, test methods, and related QC-Analytical Development documentation.
• Perform QA review and approval of equipment onboarding and qualification records, including URS, IQ, OQ, PQ, and maintenance documentation.
• Review incoming raw material documentation and support QA disposition activities.
• Support deviations, OOS/OOT investigations, and cross-functional root cause analyses.
• Provide on-the-floor QA support during GMP manufacturing operations and escalate issues in real-time.
• Review and approve GMP documents such as master and executed batch records and SOPs for accuracy, completeness, and compliance.
• Contribute to Quality System records, including Deviations, CAPAs, Change Controls, and Laboratory Investigations, as a reviewer or investigator.
• Collaborate with Manufacturing, QC, Analytical Development, and Engineering teams to support compliant and efficient GMP operations.
• Adhere to internal procedures and applicable GMP regulatory requirements.
• Participate in site quality initiatives, operational efficiency projects, and activities related to technology transfer and commercialization.
• Assist other Quality groups as needed, including document control, training, and audits.
• Communicate effectively with supervisors, colleagues, and teams.

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.

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