Minimum 5 years of relevant pharmaceutical experience
Responsibilities :
Perform complex testing and data evaluation
Perform complex Liquid / Gas Chromatography, UPLC, and other testing, and, as needed, troubleshoot issues
Participate in or assist with test method validations
Evaluate data for trends
Support supervisors in OOS Investigations and complete CAPA requirements
Interact with outside departments including attending meetings, providing updates, etc.
Coordinate testing performed at outside testing labs, raw materials, etc.
Maintain a detailed and accurate recording of activities and results on paperwork
Execute, author, and review SOPs, reports, protocols, investigations, change controls, and data summaries. Understand and use basic risk assessment and root cause tools
Train upon and understand methods, equipment and standard operating procedures
Provide training to others as needed. Attend internal and external training on related subjects, including both intra- and inter-departmental cross-training on new techniques and procedures
Support equipment upkeep
Prepare and order supplies, as necessary
Enter data into relevant data management systems. Perform tracking and trending of data as requested. Compile data and provide data summaries to management
Utilize a thorough understanding of regulatory and compliance guidelines for the pharmaceutical industry
Interact with other departments within the company for testing needs and scheduling
May lead departmental projects with the opportunity to participate in or lead cross-functional teams, including continuous improvement projects and new customer teams
May lead stability program including management of test points, reporting of data, and investigations of out of specification or aberrant stability results
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Quality Assurance • Camarillo, CA, US
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