Quality Control Scientist I
Job Code:
Q1067
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JOB DESCRIPTION
Matica Biotechnology is currently offering a unique opportunity for a highly motivated QC professional to join our team with expertise in QC Analytical and gene and cell-based assays preferably with cell and gene therapy experience. The incumbent is responsible for routine testing of analytical test methods.
RESPONSIBILITIES
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Perform routine assays on various finished products and raw materials.
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Record test results, document processing steps on Quality Control Assays while adhering to good documentation practices (GDP).
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Desired experience with: ddPCR, qPCR, HPLC, ELISA, Microscopy, and Flow cytometry.
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Perform testing in conjunction with laboratory investigations and deviations.
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Participate in various special projects according to the needs of the department.
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Participate in the drafting of procedures and / or operating manual, as needed.
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Participate in the qualification and calibration of laboratory instruments.
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Assist in investigations of analytical data deviations and OOS/OOT.
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Perform testing in support of facility validation activities.
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Collaborate with cross-functional teams to resolve complex method development challenges.
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Responsible for participation in internal audits, client audits and agency inspections of the site.
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Ability to communicate and work in a fast-paced team environment.
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Ability to work both independently and in a team-oriented environment
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Support internal and external cGMP manufacture and supply of high-quality cell and gene therapy products including, testing, QC release and stability data analyses and method data trending, deviations, out of specification investigations, and Certificates of Analysis creation.
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Perform routine inventory.
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Ensure lab is maintained (organized, clean, & properly supplied).
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Observe and report any safety issues.
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Maintain current knowledge base of regulations, corporate policies, and industry best practices, trends, and standards to ensure Quality Control functions remain in compliance with applicable company requirements and global regulations.
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Maintain a high level of integrity and professionalism when interacting with co-workers and clients.
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All other duties as assigned by Quality Control Management.
QUALIFICATIONS
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BS/BA or greater in sciences, preferably in microbiology, biology, biotechnology, pharmaceutical sciences, or related technical field.
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0-2 years related GMP experience in biotechnology, microbiology, environmental monitoring, pharmaceutical, manufacturing, or laboratory environment.
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Or 4+ years related GMP experience in biotechnology, microbiology, environmental monitoring, pharmaceutical, manufacturing, or laboratory environment.