Summary:
An industry leader in the biopharmaceutical industry is seeking a highly motivated professional to join as a Quality Specialist II at the clinical manufacturing site in Gaithersburg, MD. You will be tasked with ensuring the quality and timeliness of product to be delivered. You will be working with the Quality team in supporting efforts in a new and exciting area of cancer immunotherapy. This role will report directly to the Sr. Manager of Quality Assurance.
Job Duties:
- Provide Quality Assurance support of materials, product, environment, facility and manufacturing issues.
- Provide QA oversight in GMP cleanroom and lab environments to ensure compliance to GMP regulations.
- Implement and maintain Quality Systems for deviations, CAPAs, internal auditing, and change control.
- Review and approve deviations, LIRs, and OOS to be in compliance with SOPs.
- Support all client audits and inspections.
- Support with tracking and communication of quality metrics to management.
Requirements:
- Bachelors degree in the sciences.
- 5+ years of combined technical experience in GMP environments in biotechnology, pharmaceutical manufacturing, or biologics.
- 3+ years of Quality Systems experience.
- Practical knowledge of deviations, CAPAs, CC, auditing practices, and disposition.
