Sr. Quality Assurance Specialist
- Location: Greenville, SC
- Working situation: Onsite
- Level: Sr. Specialist
The Sr. Quality Assurance Specialist will:
- Assist in the development, implementation, and maintenance of quality systems, including SOPs, batch records, and documentation control.
- Conduct internal audits to ensure compliance with cGMP regulations and company policies.
- Assist in the review and approval of manufacturing and quality records, including batch records, deviations, and change controls.
- Support investigations of non-conformances, deviations, and customer complaints, and assist in the implementation of corrective and preventive actions.
- Assist in the preparation and review of regulatory submissions and responses to regulatory agencies.
The Sr. Quality Assurance Specialist has the following qualifications:
- Bachelor's degree in a Life Sciences or engineering discipline.
- 5+ years of experience in quality assurance within the biotech or pharmaceutical industry.
- Knowledge of cGMP regulations and quality systems.
- Previous experience is a CMO (contract manufacturer) environment.
- Ability to work effectively in a fast-paced environment and manage multiple priorities.
If you are interested in the role of Senior Quality Assurance Specialist, don't hesitate to apply today!
