
Seeking a position as a supervisor which will enable me to utilize my skills and experience while providing an opportunity for professional growth and career advancement.
Adept at maintaining and understanding all tools and instruments necessary to operate and maintain a press. Knowledge of Material Safety Data Sheet (MSDS). Familiar with proper handling, labeling, and disposal of chemicals, hazardous and non-hazardous used on a press. Strong interpersonal and communication skills with ability to interact with diverse and demanding population. Able to provide an atmosphere that encourages cooperation and communication between staff and leadership.
• Monitors, organizes and performs all functions associated with packaging of clinical trial supplies and assures compliance to good manufacturing practices, standard operating procedures, Food and Drug Administration, Drug Enforcement Agency and Occupational Safety and Health Administration rules and regulations. • Works closely with Project Management to establish manufacturing and packaging protocol section of batch record for ongoing and future studies. • Oversees both primary and secondary production areas equipped with various pharmaceutical packaging equipment including but not limited to: automated bottle line, form, fill and seal equipment, card sealing, vial and ampoule labelers, pouch equipment and medical device tray sealing. • Responsible for production involving manual and automated application of randomized labels on bottles, cards, cartons, kits, vials, syringes and ampoules. Responsible for insuring correct placement of multiple look-alike product combinations in blister units, cards and bottles. Responsible for maintaining and ordering personnel, safety, disposable and support packaging supplies. • Employee performance evaluations, new employee hiring, disciplinary notices, employee termination, according to company guidelines and performance requirements as established in the union contact. • Develops, reviews and edits related production standard operating procedures (operational, maintenance, cleaning) in Documentum program. Investigate and prepare out of specification reports and customer complaints related to production in TrackWise program. • Must review completed manufacturing and packaging batch records in a timely manner. Responsible for handling the packaging of refrigerated and frozen clinical trial material. • Responsible for daily employee training. Review and approval of production staff vacation and personal days, along with leave of absence requests. • All other duties as assigned.