QuVa Pharma | Lead Quality Assurance Specialist 3rd ...

Our Lead Quality Assurance Specialist plays a vital role in ensuring the highest quality and safety standards of our pharmaceutical products. Once you complete our training, your responsibilities will include oversight and performance of functional areas, and training in regard to processes and documentation as they pertain to quality standards and governmental regulations. Your attention to detail and adherence to precise procedures will guarantee that our medications meet the highest standards of safety, efficacy, and quality, providing patients with the best possible care and outcomes. Turn your passion for precision and your commitment to quality into a meaningful impact on healthcare across the US. This is a full-time role for our 3rd shift, working Sunday through Thursday from 10:00 PM to 6:30 AM. This is a set, consistent schedule based on site in our Bloomsbury, NJ location. This is a safety sensitive position that may be subject to random drug testing, in accordance with applicable laws. What Lead Quality Assurance Specialist Does Each Day: Ensures company compliance to QuVa Pharma's Standard Operating Procedures (SOPs) and Quality Management System (QMS) Follows all regulatory guidelines, cGMP guidelines, and aseptic techniques as required by the job function Works in accordance with area Supervision to provide quality assurance oversight where the business is responsible for adhering to current Good Manufacturing Practices (cGMPs) including warehouse, manufacturing processes, inspection, labeling and packaging, batch record review, batch disposition, and product distribution as applicable Supports department supervision in oversight and prioritization of day-to-day responsibilities. Ensures all work is performed and documented in a timely manner and according to approved standard operating procedures and in general compliance with cGMP Demonstrates a high level of discretion in the timely identification, and resolution of events potentially impacting the Quality of products and processes Provides an established technical expertise for current processes and oversees training of department personnel on new processes Maintenance of retained sample storage Reviews routine manufacturing, environmental monitoring and quality control data for in-process and finished products Evaluation of batches / product for compliance with defined specifications Sampling, inspection, and control of commercial product labels Review and approval of shipping documentation for commercial products Our Most Successful Lead Quality Assurance Specialists: Work to create an environment of open communication, participation and information-sharing within and between teams within Quality Assurance and throughout facility Are detail-oriented with strong verbal and written communications skills Support the development of a climate of quality and safety within the teams, by identifying and monitoring quality and safety standards Act decisively with purposeful pursuit of goals or objectives, and thinks strategically in terms of solutions Drive achievement, expresses energy, shows accountability, ability to multi-task and work in a fast-paced, quality-rich environment Motivate others, share knowledge, build high performing teams, show respect towards others, and give constructive feedback Minimum Requirements for this Role: A High School diploma or equivalent Able to successfully complete a drug and background check Able and willing to walk, stoop, stand, bend, and lift up to 40 lbs. throughout each shift, with or without reasonable accommodation 18+ years of age Demonstrated performance with direct supervision of a team is required At least 2 years' experience in Quality Assurance, Sterile Compounding and/or GMP production facility preferred Strong Microsoft Word and Excel skills Must be currently authorized to work in the United States on a full-time basis; QuVa is not able to sponsor applicants for work visas Any of the Following Will Give You an Edge: Bachelor's Degree in life science or related field preferred but not required At least 1 year experience at QuVa Pharma preferred At least 2 years' experience with FDA-regulated operations (cGMP processes) preferred Benefits of Working at QuVa: Set, full-time, consistent work schedule Comprehensive health and wellness benefits including medical, dental and vision 401k retirement program with company match 17 paid days off plus 8 paid holidays per year National, industry-leading high growth company with future career advancement opportunities About QuVa: QuVa is a national, industry-leading provider of pharmacy services, including ready-to-administer sterile outsourcing and advanced AI-generated insights providing clarity for revenue capture and inventory management. QuVa Pharma delivers essential medications in injectable formats critical for effective patient care. LogicStream, a QuVa company, partners with health systems to aggregate, normalize, and analyze large amounts of complex data through AI and machine learning tools that generate actionable insights supporting revenue optimization, inventory management, and inventory-related workflows. Through QuVa's integrated solutions, health systems can transform pharmacy management to achieve greater value by operating more efficiently and effectively as they deliver high-quality patient care. QuVa is an equal opportunity employer and is committed to creating and maintaining a work environment that is free from all forms of discrimination and harassment. QuVa's Equal Opportunity Policy prohibits harassment or discrimination due to age, ancestry, color, disability, gender, gender expression, gender identity, genetic information, marital status, medical condition, military or veteran status, national origin, race, religious creed, sex (including pregnancy, childbirth, breastfeeding, and any related medical conditions), sexual orientation, and any other characteristic or classification protected by applicable laws. All employment with QuVa is "at will."

Created: 2024-11-26