Life Science QC Job at Catalent – Apply Now
Are you passionate about quality, science, and making a global impact in healthcare? Catalent, Inc. is hiring a Quality Control Analyst I at its state-of-the-art Chelsea, MA facility. This exciting opportunity allows you to support pharmaceutical innovation through analytical and microbial testing, while working in a cutting-edge environment that contributes to life-saving treatments.
About Catalent, Inc.
Catalent, Inc. is a leading global contract development and manufacturing organization (CDMO) dedicated to developing, manufacturing, and supplying products that improve people’s lives. With a commitment to unparalleled service, Catalent supports pharmaceutical, biotech, and consumer health customers in product development, launch, and supply. Through its expertise in development sciences, delivery technologies, and manufacturing, Catalent accelerates development programs and launches over a hundred new products annually.
The Role:
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Environmental Monitoring (EM) of classified cleanrooms, including total particulate, viable air, and viable surface testing of ISO 8 cleanrooms
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Performs analytical testing of spray-dried powder using relevant methodologies (i.e. Delivered Dose, Anderson Cascade Impaction, Next Generation Impaction)
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Performs a variety of microbiologic assays such as bioburden, sterility testing, growth promotion testing, and microorganism isolation as QC
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Operates analytical instrumentation (i.e. Total Organic Carbon (TOC), Fourier Transform Infrared Spectroscopy (FTIR), laser diffraction, Karl Fischer)
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Critically analyzes data for reporting against specifications and/or protocols; supports Laboratory and/or Quality Investigations
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Monitors equipment and instrumentation used on a daily basis to ensure proper operation and calibration
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Prepares solutions and diluents required for analytical testing. Monitors lab supply inventory as QC
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Participates in the construction and/or revision of SOPs. Assists in the writing and updating of analytical test procedures, protocols, logbooks, and checklists
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Identifies and alerts a supervisor of issues on instruments and/or test executions; makes initial recommendations for possible solutions and/or corrective actions
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All other duties as assigned
The Candidate:
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Bachelor’s Degree in Physical or Chemical Sciences (life sciences) required
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No experience required in a cGMP-regulated environment, although it is highly preferred
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Experience with executing QC test methods, generating associated data packages, auditing data packages generated by others, troubleshooting instrumentation, trending data, and statistical analyses preferred
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Familiarity with executing Standard Operating Procedures in a GMP setting preferred
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Critical understanding of the importance of documentation and data traceability preferred for QC
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Working knowledge of cGMPs and their application to Quality Control preferred
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Ability to effectively manage time and prioritize tasks independently to meet tight timelines and shifting priorities
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Excellent oral and written communication skills
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Physical requirements: Individual may be required to sit, stand, walk, and reach regularly and occasionally lift up to 50 pounds
Why You Should Join Catalent:
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Defined career path and annual performance review and feedback process
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Diverse, inclusive culture
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Positive working environment focused on continually improving processes to remain innovative
Keywords: Quality Control Analyst, Catalent, QA/QC, Pharmaceutical Industry, Chemical Sciences, GMP Setting. Life Science QC Job at Catalent – Apply Now
