Quality Assurance Specialist
OkloFull Time
Junior (1 to 2 years)
Candidates must be a licensed pharmacist in good standing with the State Board of Pharmacy, possess at least 3 years of management experience in quality, safety, or compliance, and have over 5 years of progressive individual experience in pharmaceutical, biotech, or healthcare supply chain quality assurance. Strong knowledge of FDA, DEA, cGMP, and state pharmacy regulations is required, along with experience in conducting audits, managing CAPAs, and implementing QMS processes. Proficiency in standard tools like GSuite, Slack, and digital quality management systems is necessary, as are excellent organizational and communication skills with the ability to influence stakeholders and vendors. Preferred qualifications include experience with pharmacy operations, distribution, or manufacturing relations, familiarity with Lean or Six Sigma methodologies, and demonstrated success scaling safety and quality programs in a growth-stage organization. Occasional travel is required, necessitating the ability to sit for extended periods, lift luggage, navigate travel locations, and adjust to different time zones.
The Senior Manager, Safety and Quality will develop, implement, and manage safety protocols across supply chain and manufacturing operations, ensuring compliance with FDA, DEA, and state pharmacy regulations. They will lead internal and external audits and inspections, own quality management systems related to supply chain and manufacturing partners, and establish KPIs to track supplier quality, recalls, deviations, and CAPA. This role involves partnering with manufacturing and logistics teams to resolve quality issues, managing product investigations, complaints, and adverse event reporting, and building strong partnerships with external manufacturers, distributors, and vendors. The manager will conduct supplier risk assessments and qualification programs, support contract negotiations, and collaborate cross-functionally with various internal teams, providing guidance and training on quality and safety best practices while mentoring team members.
Digital pharmacy offering same-day medication delivery
Alto Pharmacy operates as a digital pharmacy that delivers medications directly to customers' homes on the same day. This service is designed for individuals who may not have the time to visit a traditional pharmacy. Customers can use the Alto app to consult with pharmacists about their medications, addressing any concerns they may have regarding side effects or other issues. Additionally, Alto Pharmacy helps customers save money by actively searching for coupons and discounts to provide medications at lower prices. Unlike many traditional pharmacies, Alto focuses on convenience and customer care, making it easier for people to manage their prescriptions. The company's goal is to enhance the pharmacy experience by combining fast delivery, accessible pharmacist support, and cost-saving options.