Logo
QuVa Pharma

Lead Quality Assurance Specialist 3rd Shift

QuVa Pharma, Sugar Land, Texas, United States, 77479

Save Job

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 Monday through Friday from 10:00 PM to 6:30 AM. This is a set, consistent schedule based on site in our Sugar Land, TX 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 functionWorks 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 applicableSupports 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 cGMPDemonstrates a high level of discretion in the timely identification, and resolution of events potentially impacting the Quality of products and processesProvides an established technical expertise for current processes and oversees training of department personnel on new processesMaintenance of retained sample storageReviews routine manufacturing, environmental monitoring and quality control data for in-process and finished productsEvaluation of batches / product for compliance with defined specificationsSampling, inspection, and control of commercial product labelsReview and approval of shipping documentation for commercial productsOur 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 facilityAre detail-oriented with strong verbal and written communications skillsSupport the development of a climate of quality and safety within the teams, by identifying and monitoring quality and safety standardsAct decisively with purposeful pursuit of goals or objectives, and thinks strategically in terms of solutionsDrive achievement, expresses energy, shows accountability, ability to multi-task and work in a fast-paced, quality-rich environmentMotivate others, share knowledge, build high performing teams, show respect towards others, and give constructive feedbackMinimum Requirements for this Role:A High School diploma or equivalentAble to successfully complete a drug and background checkAble and willing to walk, stoop, stand, bend, and lift up to 50 lbs. throughout each shift, with or without reasonable accommodation18+ years of age20/20 vision (with or without corrective lenses) and the ability to successfully pass a color vision testDemonstrated performance with direct supervision of a team is requiredAt least 2 years' experience in Quality Assurance, Sterile Compounding and/or GMP production facility preferredStrong Microsoft Word and Excel skillsMust be currently authorized to work in the United States on a full-time basis; Quva is not able to sponsor applicants for work visasAny of the Following Will Give You an Edge:Bachelor's Degree in life science or related field preferred but not requiredAt least 1 year experience at Quva Pharma preferredAt least 2 years' experience with FDA-regulated operations (cGMP processes) preferredBenefits of Working at Quva:Set, full-time, consistent work scheduleComprehensive health and wellness benefits including medical, dental and vision401k retirement program with company match17 paid days off plus 8 paid holidays per yearNational, industry-leading high growth company with future career advancement opportunitiesAbout Quva:Quva is a national, industry-leading provider of compounded injectable medicines and software solutions that help power the business of hospital and health-system pharmacy. Quva Pharma produces and distributes injectable medicines required by health care providers and critical to patient care. Quva BrightStream partners with health-systems to analyze large amounts of data and through AI and machine learning, develops software solutions that turns the data into insights that are used to better run their pharmacy operation. Quva's overall product and technology offerings help health-systems achieve greater value and deliver the highest-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." Equal Opportunity Employer This employer is required to notify all applicants of their rights pursuant to federal employment laws. For further information, please review the Know Your Rights notice from the Department of Labor.