Supervisor, Sterility Assurance 2nd Shift

Our Supervisor, Sterility Assurance 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 supervising Quality Assurance aspects of sterility assurance including environmental and personnel monitoring teams ensuring compliance within the facility. Operates within the legal and regulatory compliance, producing a quality product. 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.What the Supervisor, Sterility Assurance Does Each Day:Supervises all environmental and personnel monitoring (EM/PM) staff providing learning and development where appropriateEnsures standardization of site Sterility Assurance program with respect to Corporate PoliciesAbility to escalate QA decisions related to maintenance of aseptic conditions within clean rooms with a focus on Sterility Assurance during manufacturing operationsResponsible for timely and accurate in process review of EM/PM documents supporting lot release on timeProvides SME support and review of Deviations / InvestigationsMaintains environmental monitoring program including environmental and personnel monitoring results that exceed alert or action limits and interpreting resultsProvides training support for personnel on appropriate aseptic techniques and gowning techniquesPeriodically review records to verify that quality standards for each drug product is metMaintain compliance with FDA 503B and cGMP guidelines / state and federal lawsResponsible for maintaining EM/PM recordsResponsible for maintaining all testing equipment in compliance, calibration, and certification.Assists in developing policies and procedures related to Sterility AssuranceEnforces applicable personnel policies and procedureOur Most Successful Sterility Assurance Supervisors: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:Bachelor's Degree in Microbiology, Life Science or another related field2-3 years prior experience in Quality Assurance / cGMP / FDA regulated industry1 year of supervisory or management experienceExperience training personnel on aseptic techniques and appropriate gowning techniquesWell versed in the compliance & quality requirements of 503B pharmaceutical industry and CGMP's and have demonstrated strength in problem solving and resolutionMust 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:Understanding of process flows, gap assessments and analysis of data to drive improvementProficiency with computerized tracking toolsComprehensive knowledge of Adult learning techniquesBenefits of Working at QuVa:Set, full-time, consistent work scheduleComprehensive health and wellness benefits including medical, dental and vision401k retirement program with company match22 paid days off plus 8 paid holidays per yearNational, industry-leading high growth company with future career advancement opportunitiesAbout QuVa:QuVa Pharma is a national, industry-leading, FDA registered 503B outsourcing services company that provides hospitals with essential medications in ready-to-administer injectable formats that are critical for effective patient care. We are leading the way with unmatched expertise in current Good Manufacturing Practices and sterile pharmaceutical manufacturing, and the highest quality and safety standards so hospitals can more confidently and reliably focus on patient care nationwide. As a leader in sterile compounding, we continue to invest in automation and integrated technologies to improve our production processes, safety, consistency, and product quality.As part of our team, you'll experience being at the forefront of groundbreaking solutions, collaborating with brilliant minds, and making a tangible impact in healthcare delivery.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: 2024-11-27