Wat doe je als Quality Person
- Serves as a Quality person in plant in support of cell therapy manufacturing.
- Ensures Quality Oversight in plant covering various process related activities
- Performs periodic Quality checks/audits related to process, documentation and process manipulations
- Strive to reduce non-conformances and deviations in supported areas by proactively driving compliance.
- Responsible for real time review of process documentation in support of process unit operations and release activities where needed.
- Collaborate with site personnel to provide guidance and determine resolution for manufacturing issues.
- Supports in accurate and timely input, investigation and review of manufacturing deviations, CAPAs, change controls and complaints.
- Review and approve manufacturing procedures and batch records
- Perform tasks in a manner consistent with the safety policies, quality systems and cGMP requirements.
- Support regulatory inspections and audits by ensuring inspection readiness within facility.
- Perform internal housekeeping audits.
- Other duties will be assigned, as necessary.
- Aseptic processing in ISO 5 clean room and biosafety cabinets.
- Knowledge of cGMP regulations and FDA/EU guidance related to manufacturing of cell-based products as well as knowledge of Good Tissue Practices.
- Great attention to detail and ability to follow the procedures.
- The candidate must be highly organized and capable of working in a team environment with a positive attitude under minimal supervision.
- Good written and verbal communication skills are required.
- Ability to summarize and present results, and experience with team-based collaborations is a must.
- Must be able to interpret problems and effectively determine appropriate resolutions that ensure compliance and minimize risk.
- Must exhibit strong leadership skills and effectively develop others.
- Ability to collaborate well with stakeholders, customers and peers.
- Must exhibit strong decision-making ability and think creatively while maintaining compliance and quality.
- Must be able to discern the criticality of issues and to communicate to management regarding complex issues.
- Ability to manage conflict and issues that arise with internal or external customers.
- Health Insurance
- Dental Insurance
- Vision Insurance
- Life Insurance
- Matched 401K
- Flexible Spending Account
- Health Savings Account
- AD&D Insurance
- Short-Term Disability
- Long-Term Disability
- Paid Maternity Leave
- Paid Paternity Leave
- Pet Insurance
- Critical Illness Insurance
- Hospital Indemnity Insurance
- Accident Insurance
- Legal Insurance
- Commuter Benefits
- Employee Assistance Program
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