What are the responsibilities and job description for the Quality Control Associate position at Actalent?
Description:
• Be responsible for the completion of in-process, release and stability QC testing related to the manufacturing of CGT products in a controlled cGMP cleanroom environment.
• Ensure testing is completed in compliance with all applicable procedures, standards and GMP regulations.
• Work with Process Development/Analytical Development/ Manufacturing Science & Technology team, Quality and Operations to successfully transfer analytical testing to cGMP facility.
• Conduct analytical testing of raw material/reagent samples submitted to the QC laboratories.
• Perform review of laboratory data
• Create, review and approve relevant QC documents, Standard Operating Procedures, Work Instructions, Analytical Testing Methods, and Forms
• Perform assigned tasks within a CAPA, Deviation, CC or other quality-driven projects.
• Communicate effectively with management regarding task completion, roadblocks, and needs.
• Participate meetings, to provide input on timelines, potential compliance issues and other related QC activities
Skills:
Quality control, Gmp, Microbiology, Pcr, Assay, Elisa, Cgmp, Laboratory
Top Skills Details:
Quality control,Gmp,Microbiology,Pcr,Assay,Elisa,Cgmp,Laboratory
Additional Skills & Qualifications:
• B.S. Degree with 0-2 year of biotech experience preferably in a GMP environment or Advanced Degree with less than one year of biotech experience preferably in a GMP environment
• Experience in analytical techniques, including pH, Osmolality and Cell Viability testing.
• Excellent skills in Microsoft Office, data analysis software, and other related applications.
• Ability to function in a constantly evolving environment and balance multiple priorities simultaneously
• The candidate must be highly organized and capable of working in a team environment with a positive attitude under some supervision
• Comfortable with speaking and interacting with inspectors
• Good interpersonal, verbal, and written communication skills are essential in this collaborative work environment.
• Experience with Flow Cytometry, qPCR, ddPCR, ELISA, Cell Viability measurement, etc.
• Familiarity with FDA, ICH, USP and GMP guidelines pertaining to a QC lab.
• Experience in supporting lab investigations, deviations, CAPAs and change controls.
• Experience with Gene/Cell therapy products for clinical production
• Experience in performing method qualification/validation studies and supporting method transfer activities.
• Knowledge of cGMP regulations and FDA/EU guidance related to manufacturing of cell-based product
About Actalent:
Actalent connects passion with purpose. Our scalable talent solutions and services capabilities drive value and results and provide the expertise to help our customers achieve more. Every day, our experts around the globe are making an impact. We’re supporting critical initiatives in engineering and sciences that advance how companies serve the world. Actalent promotes consultant care and engagement through experiences that enable continuous development. Our people are the difference. Actalent is an operating company of Allegis Group, the global leader in talent solutions.
The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.
