JOB OVERVIEW:
The Quality Assurance Specialist I is an integral part of the Quality Assurance (QA) Team. This entry-level position will be responsible for providing Quality Assurance real-time support for Good Manufacturing Practices (GMP) cell manufacturing processes and GMP Quality Control processes by ensuring compliance with applicable regulatory requirements, company procedures, and quality standards for cell manufacturing. The Quality Assurance Specialist I works closely with Manufacturing, Quality Control (QC), Purchasing, Facilities, and Client Services to ensure safe and compliant production of the cell product.
JOB DUTIES:
Material Management: receiving, inspecting, and release of materials for GMP use.
Issuance and review of Manufacturing Batch Records (MBRs).
Perform review of any GMP documents received by QC and Manufacturing for completeness, accuracy, and compliance.
Review and approve controlled GMP documentation, including Standard Operating Procedures (SOPs), Master Batch Records (MBRs), forms, protocols, and work instructions.
Conduct real-time QA oversight of Manufacturing and Quality Control cleanroom activities to ensure adherence to approved procedures, aseptic practices, and GMP requirements as needed.
Support the QA Team with batch releases, deviations, change controls, and Corrective Action and Preventive Action (CAPA) investigations as needed.
Participate in site quality and process improvement initiatives.
Assist the QA Team in scanning of filing documents.
EDUCATION/EXPERIENCE AND SKILL REQUIREMENTS:
Bachelor’s degree in Biology, Microbiology, Biochemistry, Biotechnology, Chemistry, or a related life science discipline
0-1 years of experience in Quality Assurance, Manufacturing, Quality Control, or a regulated pharmaceutical, biotechnology, or cell therapy environment
Basic understanding of current Good Manufacturing Practices (cGMP)
Strong attention to detail and organizational skills
Excellent written and verbal communication skills
Ability to work independently while contributing effectively within a team environment
Proficiency with Microsoft Office Suite
REPORTS TO: Quality Assurance Manager
DEPARTMENT: Quality Assurance
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Celltex Therapeutics Corporation is a U.S. Equal Opportunity Employer.
