The Quality Control Specialist will be responsible for the following: Perform daily GMP Quality Control laboratory testing activities. Perform data analysis and result reporting to support product lot release with adherence to turnaround times. Support method transfers and method validation testing. Support generation and revision of documentation, such as SOPs, protocols and reports, deviations, laboratory investigations, CAPAs and change contr[ "\r\t. Execution of In-process, finished produc... more details
job summary: The Quality Control Specialist will be responsible for the following: Perform daily GMP Quality Control laboratory testing activitiesPerform data analysis and result reporting to support product lot release with adherence to turnaround times.Support method transfers and method validation testingSupport generation and revision of documentation, such as SOPs, protocols and reports, deviations, laboratory investigations, CAPAs and change contr
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Execution of In-process, finished product, and stability samples (60%)
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Support method qualifications, technology transfer and method validations (10%)
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Author/Revise SOP’s and Test Methods, Deviations, CAPA’s and Change Controls (20%)
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Responsible for inventory and instrument/equipment maintenance (10%)
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Bachelor’s degree in molecular biology, biomedical sciences or related specialties
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Minimum of 2 years experience in the pharmaceutical industry working in a GMP quality control laboratory
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Experience with cell culture, aseptic technique, cell-based potency assays, and flow cytometry
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Proficient knowledge of GMP regulations including USP and EP testing requirements
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Intermediate experience conducting time critical testing of in-process and finished product to meet in process manufacturing needs
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Ability to author, review and maintain test methods, qualification protocols, SOPs and reports
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Conduct laboratory investigations, complete deviations, CAPAs and change controls as needed
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Ability and desire to effectively work in an interdisciplinary team environment and to effectively interact at multiple levels within the company to support internal manufacturing capabilities
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Technical writing skills for drafting equipment and laboratory standard operating procedures
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Ability to follow instructions provided by SOP’s and to document results clearly and in a timely manner following performance of tasks
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Ability to work as a member of team where combined contribution, collaboration, and time bound results are expected.
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Preferred:
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3+ years of experience in the pharmaceutical industry within a GMP Quality Control role; experience with cell therapy products is a plus
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Ability to identify and implement continuous improvement projects for lab process efficiencies
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Ability to identify and escalate defects for troubleshooting and solution.
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Ability to work on assigned projects independently with limited supervision.
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Communicate effectively with team members and the ability to work cross functionally
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