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Proclinical Logo Proclinical · IT - Administration

QA Associate

United States, Angleton · Job Posted June 14, 2026
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Job Description

Proclinical is recruiting a driven QA Associate to contribute to a highly regulated quality function in the US.

Job Responsibility

  • Adhere to GMP policies and ensure compliance with quality standards
  • Prepare, review, and maintain quality documents within the QMS (MasterControl), including document control and lifecycle management
  • Support training management by maintaining accurate training matrices and records
  • Assist with internal and external audits, supplier quality activities, and CMO oversight, including document reviews, audits, and quality agreements
  • Facilitate timely and compliant final product dispositions for manufactured products
  • Write, implement, and approve deviations, investigations, CAPAs, change controls, and complaint reports, ensuring timely closure
  • Ensure compliance with aseptic techniques and sterile manufacturing regulations
  • Manage supplier/vendor assurance activities and quality agreements
  • Lead FDA-regulatory interactions for site activities and products, supporting successful submissions and inspections
  • Collaborate with manufacturing, supply chain, and cross-functional teams to support batch review, release activities, and continuous QMS improvement

Requirements

  • Bachelor's degree in Life Sciences, Quality Management, or a related field
  • Experience in quality assurance, particularly in GxP sterile manufacturing operations
  • Strong technical understanding of manufacturing quality and regulatory requirements
  • Ability to work collaboratively in a team environment and communicate effectively with diverse groups
  • Willingness to work with radioactive materials while adhering to strict safety protocols
  • Proficiency in writing and reviewing SOPs and specifications
  • Inclusive mindset with a commitment to fostering a diverse and respectful workplace
  • Strong problem-solving skills, adaptability, and a results-oriented approach
  • Commitment to ethical behavior, continuous learning, and professional development
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