This position will work closely with various departments to ensure quality system records are clearly and concisely written and that they meet regulatory authority expectations and requirements. This position will also be responsible for QA review and approval of quality systems records as well as tracking and trending of quality systems. This position will provide mentoring and guidance to quality system users througout the company on clear concise wording of qualty system records, including change controls, deviation reports, temporary variance reports, corrective action and preventive action reports, investigation reports and environmental deviations reports. This person will lead and participate in intiatives to improve quality systems compliance and efficiency as well as writing and revising standard operating procedures.
Knowledge of federal guidelines for the pharmaceutical industry and internal Standard Operating Procedures.Detail oriented with good written and verbal communication skills with the ability to deliver technical presentations to groups at all levels in the organization. Excellent computer skills with experience in MS Office applications.
Bachelor’s degree in a scientific field such as Biology, Chemistry or engineering; Master's degree preferred. At least five to seven years in Manufacturing or Quality Assurance with at least two years in an FDA regulated environment. Three years of management preferably in the quality assurance function.
Biotest Pharmaceuticals - 18 months ago