Quality Control Chemist
hace 23 horas
Rensselaer
MUST HAVE: • Bachelor’s degree in chemistry or related field, • 5+ years’ pharmaceutical experience in QC for APIs /Finished dosages, • Must have working knowledge of GC and HPLCs Responsibilities: Essential job duties • Perform analytical testing for incoming, in-process, raw material and final products, and stability samples using equipment such as balances, pipettes, pH meter, UV/Visible spectrophotometer, Total Organic Carbon analyzer, etc., • Perform chromatography (Liquid/GC) after extensive qualification and training, • Perform wet chemistry assays, • Regularly perform water sample collection, • Back up for QC analytical instrument maintenance and calibration, • Performance of QC general laboratory equipment maintenance, laboratory housekeeping and preparation of the laboratory for audits, • Assist in the review of QC data and provide summaries to management as needed, • Assist QC Management, as needed, in the completion of OOS, deviations and CAPAs investigations for QC, • Backup for QC analytical sample receipt for internal testing, outside laboratory testing, login, processing, shipment, tracking, distribution of test results, and closure 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, professional journals, technical procedures, or governmental regulations, • Ability to write reports, business correspondence, and procedure manuals, • 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, • Proficient use of computer software, including Microsoft Office Suite and instrument manufacture-based systems 11. Knowledgeable in FDA GMPs (21 CFR, 211, 820, and/or 600); ISO 9001 and 13485 a plus, • Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables