QC SUPERVISOR
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WHAT IS OFFERED
Be part of an international and diverse team, whilst developing one of the breakthrough innovations within healthcare and technology.
This is a unique opportunity to have impact, write history and challenge yourself in a highly novel environment.
ABOUT THE COMPANY
MindCapture supports in the recruitment of this talent for a global biotech company that’s developing, manufacturing and commercializing new cell-based therapies to battle cancer with focus on immunology. They are developing advanced cell therapies across a diverse array of technology platforms, including autologous and allogenic chimeric antigen receptor T-cell and natural killer (NK) cell-based immunotherapy.
Our partner is looking for a QC supervisor with responsibilities for providing quality control over the production of personalized cell therapies to support both clinical and commercial requirements in a sterile GMP environment.
JOB DESCRIPTION
As a QC supervisor you will be responsible for supervision of QC analists as well as troubleshooting issues. You will report directly to the QC manager.
- Responsible for both IPC (in process analyses) as EMS (environmental monitoring).
- Ability to read, interpret and revise documents such as SOPs, work instructions.
- Develop positive relationship with the QC team, Quality Assurance, Information Technology, Maintenance, Manufacturing personnel, Technical Operations personnel, Human Resources, Site Leadership Team members, and peers.
- Harmonize with Environmental, Health, and Safety personnel, Product Development, and Quality/Manufacturing personnel.
- Independently make appropriate and compliant GMP decisions.
- Independently resolve problems through the use of quality systems.
- Develop improvement ideas and independently implement associated solutions.
- Support QC analysts team development.
- Possess the ability to positively influence peers, key stakeholders and management.
- Generates shift schedules, to ensure efficient coverage for all operational needs.
- Maintain individual training completion in a compliant state.
- Support the completion of corrective and preventive actions, as necessary.
- Support internal/external audits.
- Support Quality risk assessment teams.
- Review/approve documents as a Quality Control Subject Matter Expert (SME).
- Remain current in skills and industry trends.
- Detailed knowledge of Quality and Compliance standards.
REQUIRED COMPETENCES & SKILLS
- Bachelor’s Degree in Science, Engineering or equivalent or relevant years of experience within the pharmaceutical industry
- 5+ years relevant work experience is required, preferably in an aseptic manufacturing facility and in quality control, quality assurance, manufacturing compliance, clinical quality, or cell therapy.
- A minimum of 1 year leadership experience is required.
- Knowledge of cGMP regulations and FDA/EU guidance related to manufacturing and quality control of cell based products as well as knowledge of Good Tissue Practices.
- Strong interpersonal and written/oral communication skills.
- Ability to quickly process complex information and often make critical decisions with limited information.
- Ability to handle multiple priorities on a daily basis while being flexible and responsive to frequently shifting priorities.
- Proficient in applying process excellence tools and methodologies.
- Ability to independently be responsible for a portfolio of ongoing projects.
- Ability to pay attention to details and follow the procedures.
- The candidate must be highly organized and capable of working in a team environment with a positive attitude under some supervision.
- Good written and verbal communication skills are required.
- Ability to summarize and present results, and experience with team-based collaborations is a requirement.
- Experience directly supervising employees is preferred.
- Ability to work with and lead others in a team environment.
- Experience developing and setting long-term objectives.
- Detailed knowledge and understanding of current Good Manufacturing Practices (cGMP) and current Good Tissue Practices (cGTP) related to CAR-T manufacturing or cell processing.
- Ability to identify/remediate gaps in processes or systems.
- Experience with ICH and/or 21 CFR parts 210, 211, 1271 is required and 600, 601, and 610 is preferred.
- Experience reviewing/auditing documentation.
- Proficient with using Microsoft Office applications (Outlook, Excel, Word, and Powerpoint).
Important: this challenge is within a shift schedule, with the advantage of working 4 days per week (10 hours/day) with 4 days off. Shifts include routine weekend and evening work as required by the process. This shift system can help you avoid traffic and reduce time spend in the car
