Job Description
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-training
Essential Functions and Responsibilities
Provide oversight of QA floor support team.
Supervise, prioritizes, and coordinates the daily activities of the QA staff within the department
Facilitates 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.
Qualifications
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Bachelor 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 biologics
Minimum 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.
Quality Requirements
Build Quality into all aspects of your work by maintaining compliance to all quality requirements.