Duties and Responsibilities:
The primary responsibilities include:
• Serve as the site GMP compliance subject matter expert and liaison to facility personnel
• Serve as a contact and aid during inspections by regulatory health authorities.
• Assist with the approval or rejection of all components, drug product containers, closures, in-process materials, packaging material, labeling, and drug products, and the authority to review production records to assure that no errors have occurred or, if errors have occurred, that they have been fully investigated.
• Assist with the approval or rejection for all procedures or specifications impacting on the identity, strength, quality, and purity of the drug product.
• Review and approve GMP documentation including but not limited to, specifications, batch production and control records, test methods and test results, stability protocols and reports, validation protocols and reports, deviation reports, investigation reports, corrective and preventive actions, change control requests, environmental monitoring reports, etc. for commercial product.
● Bachelor’s degree in a scientific related discipline (e.g. Chemistry, Biology, or other life science)
● Minimum of 3+ years of experience with Good Manufacturing Practice quality system development and implementation in a pharmaceutical manufacturing facility
● Available to work flexible hours to accommodate radiopharmaceutical manufacturing schedules
• Knowledge of Current Good Manufacturing Practice (21 CFR 211)
• Knowledge and experience with quality assurance oversight of aseptic manufacturing processes
• Knowledge and experience with pharmaceutical quality systems and quality assurance concepts
• Radiopharmaceutical experience a plus.
• Excellent communication skills both verbal and written.
• Strong problem- solving skills.
• Effective interpersonal skills.
• Must be able to manage multiple priorities.