Camarillo, CA30+ days ago
Knowledge, skills and abilities • Excellent verbal and written communication skills, including the ability to effectively present information and respond to questions from groups of managers, clients, customers, and the general public • Ability to meet deadlines and work under pressure with limited supervision • Strong time management and organizational skills with the ability to multi-task and manage multiple projects independently • Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, or governmental regulations • Ability to write reports, business correspondence, and procedures • Ability to apply advanced mathematical concepts such as exponents, logarithms, quadratic equations, and permutations • Ability to apply mathematical operations to such tasks as frequency distribution, determination of test reliability and validity, analysis of variance, correlation techniques, sampling theory, and factor analysis • Ability to define problems, collect data, establish facts, and draw valid conclusions • Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and handle several abstract and concrete variables • Proficient use of computer software, including Microsoft Office Suite and instrument manufacture-based systems • Knowledgeable in FDA GMPs (21 CFR, 211, 820, and/or 600); ISO 9001 and 13485 a plus. Compile data and provide/present data summaries to management • Utilize a thorough understanding of regulatory and compliance guidelines for the pharmaceutical industry • Collaborate with cross-functional departments to coordinate testing, scheduling needs, and prioritization • Lead departmental projects and participate in cross-functional teams, including continuous improvement initiatives and new customer project teams • Lead the stability program, including management of test points, reporting of data, and investigations of out of specification or aberrant stability results.