Strong cGMP knowledge and their respective applications in pharmaceutical operations.
• Analytical and problem-solving skills.
• Written and verbal communication skills.
• Ability to work in an aseptic manufacturing environment.
• Proficient in MS Office application.
Essential Duties and Job Functions:
Performs environmental and/or utility monitoring and sampling as a primary function. Performs on-site testing of utility and environmental where applicable. Participates in validation and commercial/developmental manufacturing activities Reviews and issues Environmental Notifications based on raw data, and validated electronic data acquisition systems.
• Works on problems moderately complex in nature where analysis of situations or data requires review and evaluation of various factors, moderate judgement is required in resolving problems and making routine recommendations. Exercises judgement within defined company practices and policies in selecting methods, techniques, and evaluation criteria for obtaining results.
• Performs a wide variety of routine sampling of pharmaceutical manufacturing areas including critical utilities while noting any discrepancies.
• Writes and updates environmental monitoring procedures and forms as necessary.
• Participates in the execution of validation and process improvement activities.
• Responsible to schedule and maintain communication with manufacturing, maintenance, engineering and validations in order to complete all required environmental and critical utility monitoring per internal procedural requirements with minimal impact to interdepartmental schedules.
• Ensure all activities are followed per procedure and documented accordingly.
• Perform environmental sampling as required for a pharmaceutical aseptic manufacturing environment.
Knowledge, Experience and Skills:
Typically requires a HS diploma and minimum 3 years of relevant experience and advanced certification in assigned area required, or an AA degree and minimum 2 years of relevant experience preferred. Must have proficiency in general Microbiology techniques such as gram staining, aseptic technique, and plate streaking technique. Good laboratory and computer skills are required. Knowledge of cGMP, USP and other regulatory requirements
Gilead - 20 months ago
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