Quality Assurance Specialist, Supplier Quality
4 weeks ago
- Performs the following duties with minimal supervision.
- Adhere to GMP practices.
- Accurately review and approve controlled documents including suppliers Certificates of Analysis or Certificates of Conformity.
- Inspect incoming and manufactured materials for accuracy and defects.
- Work closely with other departments to release materials for GMP use.
- Maintain documentation in an organized manner both physically and electronically.
- Maintain a shared, organized workspace.
- Support change controls, as needed.
- Support site inspections, as needed.
- Work closely with functional groups to ensure processes and personnel remain in compliance with site procedures, regulatory and cGMP guidelines.
- Perform other duties as required.
- Minimum of a Bachelor’s degree in related field and/or equivalent experience.
- Preferred at least 1 year of experience in quality and/or manufacturing in a pharmaceutical, biotech, or biologics cGMP regulated manufacturing environment preferred.
- Working knowledge of systems and ability to apply cGMPs in conformance to U.S. standards, and where appropriate, other regulatory authority standards.
- Ability to work effectively and efficiently with minimal supervision.
- Possess basic problem-solving skills.
- Excellent organizational skills, attention to detail, and Good Documentation Practices.
- Proficiency in MS Word, Excel, Power Point, Microsoft Office 365 and other applications.
- Must possess effective interpersonal, verbal, and writing skills, patience, professionalism, and the ability to effectively interact and communicate with internal staff and management.
- Comfortable in a fast-paced, patient-focused manufacturing environment with minimal direction and able to adjust workload based on changing priorities.
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