RemedyRepack is a firm believer in total quality management (TQM) and, we have implemented a set of strong quality practices which are geared to ensure that we consistently meet or exceed customers’ requirements. As a means of continuous improvement, RemedyRepack places a major emphasis on process measurement, analysis, documentation, communication, and controls. Remedy’s quality management ensures the highest levels of excellence and service for our customers and routinely reviews the batch record, verifies labels, and inspects products.
Director of Operations and Quality Assurance
Susan serves as RemedyRepack’s Director of Operations and Director of Quality Assurance. She is responsible for daily operations, including quality control, production, administration, purchasing, customer service, and shipping and receiving. Sue has developed and continuously improves Remedy’s quality assurance program. She also successfully developed Remedy’s standard operating procedures as well as our policies and procedures. Additionally, she spends a great deal of time ensuring that RemedyRepack staff is fully trained and aware of specific rules and regulations that must be followed in the repackaging industry.
Until 2013, Sue served as the Operations Manager and Quality Assurance Director for Diamond Pharmacy Services Distribution Center. In that position, she worked with the National Association of Boards of Pharmacy (NABP) and all appropriate Diamond components to oversee and coordinate the entire process for Diamond to obtain certification and recertification. Sue has over a decade of pharmaceutical experience, having begun her career with Diamond Drugs, Inc., the parent company of RemedyRepack, in 2004.
Sue has a comprehensive and current understanding of state-level statutes and regulations regarding the Drug Quality and Security Act (DQSA) and the required transaction history information, and statement. She is listed with the Florida Department of Business and Professional Regulation as a certified designated representative (CDR), which is a requirement for all drug wholesale distributors and out-of-state prescription drug wholesale distributors. She also is listed with the California State Board of Pharmacy as a designated representative, which is required of the individual in charge of any resident or non-resident wholesale drug distributor doing business in that state.
Sue currently serves as a member of the American Society of Quality (ASQ) and is pursuing ASQ certification as a Certified Manager of Quality. She also is a member of the International Society for Pharmaceutical Engineering (ISPE). Sue currently holds certifications as a Good Manufacturing Practices Certified Professional (GMPCP) as well as, Global Regulatory Affairs Compliance Professional (GRACP).
Gerald R. O'Brien, Jr.
Jerry serves as RemedyRepack’s Acting Compliance/Regulatory Affairs Officer. In this position, he conducts training seminars focusing on FDA regulations and cGMP compliance for the RemedyRepack staff. He also serves as Chief Counsel for Diamond Drugs, the parent company of RemedyRepack and Diamond Pharmacy Services.
After graduating from Duquesne University Law School in 2002 and before becoming a Diamond/Remedy employee, Jerry worked in private practice for over a decade. During that time, he represented Diamond Drugs, handling various litigation and transactional matters, as well as compliance issues with respect to various State and Federal regulatory entities.
Quality and Compliance Manager
Danielle serves as a Quality and Compliance Manager. She oversees Remedy’s Quality Assurance Technicians. Her department is responsible for approving or rejecting all production runs, as well as detecting and resolving errors of the finished product.
Danielle’s decade of experience includes an array of duties in the pharmaceutical industry including quality control, internal audits, customer service, training, and shipping and receiving. She also assists the Director of Quality Assurance in preparing and auditing Remedy’s standard operating procedures. Additionally, she ensures that they comply with Current Good Manufacturing Practices (CGMPs). She has played a key role in the development and execution of an all-encompassing training program that is required of every RemedyRepack employee.
Danielle is listed with the Florida Department of Business and Professional Regulation as a certified designated representative (CDR), which is a requirement for all drug wholesale distributors and out of state prescription drug wholesale distributors.
cGMP Compliance Supervisor & Purchasing Agent
Dennis serves as RemedyRepack’s Purchasing Agent and as one of Remedy’s cGMP Compliance Supervisors. He has over four years of experience with Remedy.
Denny’s daily duties include purchasing medications from manufacturers and NABP-accredited wholesalers, assigning daily repackaging runs to production teams to achieve peak workflow efficiency, ensuring that Remedy’s building and equipment comply with FDA rules and regulations—including the calibration and validation of machinery and other equipment. Additionally, he verifies that the vendors Remedy uses for all manufacturing materials are in compliance with federal and state authorities. Staffing issues are also under Denny’s purview and he maintains active oversight of employees in his department.
Melissa serves as one of Remedy's Production Supervisors. In her supervisory capacity, Melissa oversees production technicians, production facilitator, and two printing press operators. She assigns daily production runs, focusing on workflow efficiency. Melissa plays an integral role in the training and evaluation of all RemedyRepack employees regarding job competency and cGMP compliance.