QA Specialist II

This position is responsible for the compliance review of Biopharmaceutical Development GMP data, including the review and approval of release, in-process, and stability test data, as well as method qualifications and validations.

Requirements

• BS and 11+ years experience or MS and 8+ years experience in a CGMP regulated environment within biopharmaceuticals or equivalent.
• Experience in QA review of analytical data (release, in-process, and stability), experience in reviewing method qualifications/validations and the review and approval of laboratory investigations and deviations.
• Knowledge of USP, EU and JP cGMP guidelines.
• Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, or governmental regulations.
• Ability to write reports, business correspondence, and procedure manuals.
• Ability to effectively present information and respond to questions from groups of managers, clients, customers, and the general public.
• Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists.
• Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form.
• Basic math skills are required.
• Ability to apply concepts of basic algebra and statistics.
• Be able to sit for long periods of time.
• Ability to lift 20 pounds.
• Ability to use word processing, database, spreadsheets, power point, internet, e-mail, calendar, computer, telephone