TALENT Software Services
Responsibilities include:
Conduct biochemical, physical, and chemical analyses of test samples under cGMP with direct to minimal supervision, ensuring completion within specified timelines. Evaluate data against established criteria and specifications. Independently perform assays that have been mastered. Maintain and develop proficiency across a wide range of trained test methods. Train other analysts in areas of expertise. Keep the laboratory in a state ready for inspection. Manage laboratory supply inventories. Ensure routine laboratory functions, such as glassware cleaning, are completed to support business needs. Develop familiarity with cGMP, 21CFR, USP, EP, and ICH regulatory requirements. Interact with other departments as appropriate. Hold oneself and others accountable to adhere to department and company policies and practices. Assist in the revision of written procedures as assigned. Perform other duties as assigned.
Required Skills
Ability to follow written instructions and perform tasks with direct or minimal supervision. Proficiency in using a computer, including Windows, Microsoft Word, and Excel. Strong written, verbal, and communication skills. Excellent documentation skills. Demonstrated ability to work independently.
Desired Skills
At least one year of experience in a cGMP/GLP laboratory; quality control experience is preferred.
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Conduct biochemical, physical, and chemical analyses of test samples under cGMP with direct to minimal supervision, ensuring completion within specified timelines. Evaluate data against established criteria and specifications. Independently perform assays that have been mastered. Maintain and develop proficiency across a wide range of trained test methods. Train other analysts in areas of expertise. Keep the laboratory in a state ready for inspection. Manage laboratory supply inventories. Ensure routine laboratory functions, such as glassware cleaning, are completed to support business needs. Develop familiarity with cGMP, 21CFR, USP, EP, and ICH regulatory requirements. Interact with other departments as appropriate. Hold oneself and others accountable to adhere to department and company policies and practices. Assist in the revision of written procedures as assigned. Perform other duties as assigned.
Required Skills
Ability to follow written instructions and perform tasks with direct or minimal supervision. Proficiency in using a computer, including Windows, Microsoft Word, and Excel. Strong written, verbal, and communication skills. Excellent documentation skills. Demonstrated ability to work independently.
Desired Skills
At least one year of experience in a cGMP/GLP laboratory; quality control experience is preferred.
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