Supervisor, Quality Assurance

Supervisor, Quality Assurance At Minaris Regenerative Medicine our vision is creating future cell therapy miracles together. We are a leading global contract development and manufacturing organization dedicated to the advancement of cell and gene therapy products. We believe in the transformative potential of cell and gene therapies and we are shaping the future of medicine. We open doors in the regenerative medicine industry for those looking to transform medicine while continuously improving an innovative, growing company.The Supervisor, Quality Assurance is responsible for providing quality oversite to Quality Assurance team according to Minaris Quality policies, procedures, and standards. Provide oversite for material releases, final product releases; as well as assists Quality management with department needs. He/she exercises judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions. He/she helps the team understand performance targets and goals. Ensuring that workers are properly trained for their specific roles. Coordinating job rotation and cross-trainingEssential Functions and ResponsibilitiesProvide oversight of QA floor support team. Supervise, prioritizes, and coordinates the daily activities of the QA staff within the departmentFacilitates internal training on quality assurance requirements, processes, and procedures.Provides technical expertise to the client services team on tech transfer activities. Must have knowledge in investigations, CAPA, change control and complaint process. Manage Batch issuance and Batch Record Tracking System. Review and approve Minaris SOPs, WIs, and Forms.Supports QA teams with continuous improvements initiatives to enforce quality culture. Initiate critical change control as required. Assist gathering information for internal and external (e.g. cGMP, client, regulatory agencies) audits.Support walk thru in preparation for internal and external (e.g. cGMP, client, regulatory agencies) audits.Other duties as assigned. QualificationsBachelor of Science in biological sciences or other relevant field of study Minimum 5 years' experience in QA in a life sciences company with a strong focus in the manufacturing and/or testing of biologics. Working knowledge and technical understanding of aseptic manufacture of biologicsMinimum 1-year supervisory experience. Equivalent combination of education and experience acceptable Experience in both clinical and commercial manufacturing is preferred.Experience in authoring, reviewing, and /or approving cGMP/cGTP related documents MBR, reports, SOPS. Etc.Experience in organizing teams for effective and timely completion of projects.Understanding of quality system applications, including the use of electronic applications for training, deviations, CAPA management, etc.Experience participating in or hosting health authority inspections and/or client audits.Competencies/Candidate ProfileRelevant computer skills (Microsoft Office, Outlook)Detail-oriented and organizedAnalytical and problem-solving skillsGood written and oral communication skillsAbility to multi-task and be adaptableFlexible and able to adapt to company growth and evolving responsibilitiesAbility to work independently and with a teamStrong Project Management and organization skillsConfident in making decisions on non-routine issues Supervisory ResponsibilityCarries out supervisory responsibilities in accordance with the organization's policies and applicable laws.Responsibilities include interviewing, hiring, and training employees; planning, assigning, and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems for the following positions. Directly supervised the following roles:QA Associate I QA Associate IIQA Associate IIIDirectly supervises 3-5employees within the QA department.Quality Requirements Build Quality into all aspects of your work by maintaining compliance to all quality requirements.Ensure compliance to all FDA and Worldwide Quality & Compliance regulations (As applicable to the job function).Attend all required Quality & Compliance training at the specified interval.Minimum Required Training to be Completed within first 90 days of hireGXP trainingSOP & WI trainingSafety TrainingGMPWorking EnvironmentMust have the ability to work in a team-oriented environment and with clientsMust be able to work during the weekend, holidays and as required by the companyMay be exposed to infectious diseases transmittable through human blood, tissues, or bodily fluidsMust utilize proper personal protective equipment (PPE) when handling all human specimens, gases, corrosive chemicals, etc.Understanding of quality system applicationsMust be able to handle the standard/moderate noise of the manufacturing facilityPhysical RequirementsMust be physically capable to stand; walk; sit; bend; stretch; use hands to finger, handle or feel; reach with hands and arms; and talk or hearThe employee is frequently required to lift and/or move up to 30 pounds. Direct Reports3-5DisclaimerPlease note this job description is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice. Tuesday-Saturday, 2nd Shift

Created: 2025-01-29