The Quality Analyst will be a key contributor in executing and overseeing Quality Control (QC) and Quality Assurance (QA) activities to support the manufacturing and release of cell therapy products. This role involves performing advanced QC testing, managing QA processes, and ensuring compliance with regulatory standards and company policies. The ideal candidate will leverage their expertise and strong communication skills in a collaborative environment to uphold GLP/GCLP functions while fostering continuous quality improvement.

Key Responsibilities:

Quality Control:

• Perform and analyze critical QC tests, including but not limited to:
• Sterility testing
• Mycoplasma detection
• Cell count and viability assays
• Endotoxin analysis
• Flow cytometry
• Develop, validate, and implement new testing methodologies and standard operating procedures (SOPs).
• Conduct data analysis, troubleshoot issues, and maintain comprehensive, accurate test records.
• Ensure QC testing is completed efficiently to align with manufacturing and release schedules.
• Oversee laboratory equipment calibration, maintenance, and troubleshooting.

Quality Assurance:

• Oversee batch disposition activities, reviewing batch records, deviations, in-process data, environmental monitoring data, materials management, QC release testing, and other quality systems to determine product disposition.
• Manage and investigate deviations, root cause analyses, out-of-specification (OOS) results, and implement corrective/preventive actions (CAPAs).
• Collaborate with cross-functional teams to drive process improvements and ensure compliance with current Good Manufacturing Practices (cGMP).
• Maintain QA documentation systems, including controlled document updates and training records.
• Ensure thorough adherence to cGMP, ICH, USP, and FDA regulatory requirements.

Qualifications:

• Education: Bachelor’s degree in Biology, Biomedical Sciences, Microbiology, Biotechnology, or a related field; an advanced degree is preferred.
• Experience: Minimum of 5 years in a Quality Control or Quality Assurance role within the biotechnology, pharmaceutical, or cell therapy industries.
• Experience with aseptic gowning and manufacturing in an ISO 7 cleanroom environment.
• Technical Skills:
• Proficiency in QC techniques such as sterility testing, mycoplasma detection, cell viability assays, and flow cytometry.
• Strong understanding of QA processes, including batch record review and deviation management.
• Familiarity with regulatory requirements (e.g., FDA, EMA) and GxP standards.
• Hands-on experience with lab equipment and quality management systems.
• Soft Skills:
• Exceptional organizational skills with keen attention to detail.
• Strong analytical, problem-solving, and decision-making capabilities.
• Excellent communication and teamwork abilities.

Contract Details:

• 6 Months
• Sponsorship unavailable