MAJOR DUTIES AND RESPONSIBILITIES:
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Routinely reviews and releases environmental testing, raw materials, in-process/bulk/intermediate, finished product, stability, and method validation/transfers.
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Creates COAs for finished goods batches.
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Oversee daily operation of QC Laboratory.
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Occasionally performs testing, and accurately records raw data, analyzes data, and calculates and interprets the results.
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Order supplies ensuring that the laboratory is adequately supplied.
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Manage the reference standards/materials program.
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Plan daily technical activities in order to meet established timelines. Provide input to establish project timelines.
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Qualify, calibrate, and maintain laboratory equipment, including review of activities and data.
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Support general laboratory maintenance.
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Support site and Technical Operations validation and assessment activities such as reviewing and approving protocols and reports.
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Write, review, and revise SOPs as required.
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Ensure testing is performed accurately and in compliance with GLP, GMP, USP, SOP and other approved test methods
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Proactively investigate and identify areas of improvement.
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Investigate, support, validate and implement new laboratory procedures and techniques.
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Provide monthly lab metrics to management.
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Maintain a level of technical knowledge and understanding of Analytical testing consistent with current scientific literature.
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Perform scientific literature searches and evaluations as needed.
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Design, within a defined scope, experiments or a series of experiments to address specific project goals.
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Train laboratory personnel in lab techniques as required
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Responsible for Cleaning Validation and Method Validation activities.
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Follow cGMP, cGLP and OSHA guidelines with regards to work practices and safety.
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Other duties which may be assigned sometimes by site management.
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A minimum of a BS in Chemistry or related field
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Minimum of 5 years’ experience preferably in the pharmaceutical industry
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Capable of preparing cGMP and other laboratory documents
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Excellent knowledge of computer systems and software
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Good knowledge of cGMP and FDA regulations
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Excellent interpersonal, organizational, communication skills
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GMP Manufacturing and Laboratory Environment
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May be exposed to laboratory chemicals and solvents