Amanda White Email & Phone Number

· Collaborates with key external stakeholders to manage the relationship of our CMO’s; inclusive of preparation of Scope of Work, production planning, coordination of DEA and procurement documents, and management of special requests and issue resolution.· Manages the flow of information that is needed for On-time, In-full shipments from our contract manufacturer. · Leads daily/weekly planning/customer service alignment meetings to ensure good communication and uninterrupted supply from product release to customer. · Executes business level decisions on the short horizon to prioritize production when needed· Establishes effective communication with various groups such as customer service, sales, quality control, quality assurance, DEA compliance, and Warehouse & Logistics, and Production.· Coordinates with sales team on current and future production plans to communicate ability to supply· Manages approximately 100,000kg of inventory that will lead to yearend sales of approximately $160 million.· Works closely with Planning and Customer Service on both a short and long term horizon to ensure continuity of product release and communicate barriers when present. Works with Customer Service team to alleviate barriers when possible.· Compiles inventory lists for material destined for reprocessing or disposal. Works with Planning and DEA Compliance to ensure proper classification of such material. · Monitors orders from start to finish

Wilmington, De

• Testing of raw and intermediate materials, & finished product Active Pharmaceutical Ingredients to determine purity and chemical content based on FDA, DEA and Company specifications.• Close following of all standardized operating procedures to ensure compliance with cGMP, GLP, company policies & regulatory requirements. • Careful review and release of analytical testing performed by analyst to ensure cycle time are met & compliance maintained. • Assistance in the investigation of non-conformances generated in lab, as well as in the manufacturing plant, as requested by QC supervisors and Process Engineers.• Calibration, troubleshooting and proper documentation of use on all laboratory instrumentation prior to due date and/or at time of use.• A mindset of quality and safety, with respect to self, co-workers and environment, is maintained at all time during testing and while on site to ensure perfect quality control Right First Time is maintained. • As a Product Team Lead, intermediate testing is planned and coordinated with team members through proper time management and good communication to ensure testing is completed and the release of results are delivered under strict cycle times.• As the main purchaser of lab and office supplies, ordering of materials through the J&J Ariba system as needed to maintain lab proficiency is done through weekly inventorying and the use of Kanban Cards. Forecasting of materials needed based on production schedule is also key. • Training of new Analyst on GMP/GLP procedures and company policies, as well as laboratory tests, to develop an efficient workforce and motivated employees who can achieve maximum productivity in a fast-paced and rapidly growing company.

• Use of a computer system to verify, weigh and record chemicals in specific formula, then combine into appropriate dosage as requested by the prescription, under the supervision of a licensed pharmacist.• Non-sterile compounding of suspensions, solutions, capsules, tablets, troches, pet treats and topical creams, lotions and gels.• Calibration and proper documentation of scales, electronic meters and other laboratory equipment. • Strict following of all safety procedures, including the safe handling and disposal of bulk active pharmaceutical ingredients, based on company, FDA and GMP guidelines.

• Ensure that all sterile and non-sterile products (liquid, capsule and injectable) are free of contaminants and fit for consumer use through visual inspection. • Proofread and adhere product labels according to USP regulations and company policy for both accuracy and esthetics. • Confirm the proper handling, documentation and distribution of controlled, cytotoxic and all other medications according to USP regulations and company policy. • As a central department in the pharmacy, QA technician acted as a liaison between the customer care associates, Pharmacist and compounding laboratory to keep all informed on the status of orders and the collaboration of all necessary technical materials.

Bachelor'S Degree, Biopsychology

Education record

Associate Of Science (As), Chemistry

Associate Of Science (A.S.), Biology, General