Supervisor, QA OTF Support - Medvacon Life Sciences

•  Provide oversight of the “QA on the Floor” program and supervision of OFT processes and personnel.
•  Ensure staff are fully trained on all cGMP manufacturing operations and documentation and adhering to safety guidelines; build effective teams that apply their diverse skills and perspectives to achieve common goals; oversee daily activity for the group to ensure quality results Performance management for direct reports.
•  Drives and owns the “Quality on the Floor” program by facilitating the desired ‘way of working’ and a quality culture; plans and coordinates the activities of the OTF team to ensure coverage for all manufacturing activities.
•  Provide QA oversight, technical expertise and leadership across all aspects of product manufacturing and operations support; develop and update relevant procedures; monitor, participate and oversee the real time batch record review process, including escalation of issues while on the floor.
•  Ensure manufacturing compliance with applicable procedures and batch records; review manufacturing shop floor documentation, including logbooks, calibrations etc; play a key role with resolution of quality investigations and CAPAs.
•  Ensure that own and teams KPI’s, plans, targets and objectives are effectively monitored and achieved. Including standard lead-times and supporting the Business goals for e.g. RFT and OTD/ OTIF; embrace and actively drive Practical Process Improvements (PPI). Directs quality initiatives that accomplish continuous improvement and enhance site quality system efficiencies.
•  Partner with manufacturing and key stakeholders to prioritize projects aligning with the quality goals and objectives; ensure quality events are captured, investigated and closed appropriately in the Trackwise system.
•  Actively participates in training activities, managing their individual training plan; also ensures interaction with other shifts given the 24/7 operations.
•  Leads by example, keeping in mind organizational values, policies and goals. Develops people and team coaching and collaboration; proactively partners with Human Resources to attract and retain top talent and takes an active role in ensuring new employee onboarding is a success.
•  Other duties as assigned.
   

•  Masters’ degree in a Scientific, Engineering or Biotech field with 4 years’ experience in Quality Assurance/Quality Control/Manufacturing within biologics, biopharmaceuticals, or a regulated industry OR Bachelor’s degree in a Scientific, Engineering or Biotech field with 6years’ experience in Quality Assurance/Quality Control/Manufacturing within biologics, biopharmaceuticals, or a regulated industry.
•  Familiarity with Good Manufacturing Practices (GMPs), 21 CFR Parts 210, 211, biological regulations per 21 CFR Parts 600s, ICH Guidelines and EU GMPs; Knowledgeable and/or exposure to biological manufacturing processes including microbial and cell culture cell banking, fermentation/cell culture, purification and fill/finish.
•  Familiarity with electronic systems, including developing and producing reports using Microsoft products. LIMS, Master Control and Trackwise knowledge preferred; Have the knowledge, and ability to apply basic scientific and regulatory principles utilized to solve operational, as well as routine quality tasks.
•  Creative individual with excellent analytical, trouble shooting, and decision-making skills; ability to quickly learn new and novel manufacturing processes supporting new clients; ability to produce results in a fast-paced environment to meet client deadlines; able to work in a team setting and independently, under supervision; creative thinking with the ability to multi-task; commitment to ongoing professional development.

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