What are the responsibilities and job description for the Sr QA Specialist position at KBI Biopharma?
This position is responsible for the compliance review of Biopharmaceutical Development GMP data. This includes the review and approval of release, in process, and stability test data. This position is also responsible for the review and approval of method qualifications and validations. Another responsibility is the review and approval of laboratory investigations and deviations associated with the biopharmaceutical development department.
Job Responsibilities :
Perform compliance review on the following records - release, in process, and stability data
Responsible for the review and approval of method qualifications and validations
Responsible for the review and approval of deviations and laboratory investigations
Minimum Requirements :
BS and 14 years experience or MS and 11 years experience in a CGMP regulated environment within biopharmaceutical 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
Ability to sit for long periods of time and to be able to lift 20 pounds
ability to use word processing, databases, spreadsheets, PowerPoint, internet, email, calendar, computer, telephone
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