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QA Associate
- Angleton, Texas, United States
- Angleton, Texas, United States
Über
Proclinical is recruiting a driven QA Associate to contribute to a highly regulated quality function in the US.
Primary Responsibilities The successful candidate will support quality assurance operations, ensuring compliance with GxP standards and the Quality Management System (QMS). In this role, you will collaborate with cross‑functional teams to maintain high‑quality standards in manufacturing and regulatory processes.
Skills & 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.
QA Associate Responsibilities
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.
If you have any questions, please contact Anderson Maldonado at a.maldonado@proclinical.com.
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Sprachkenntnisse
- English
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