An organization with incredible success of completing development of life-changing pharmaceuticals and medical devices is looking to add to their organization!
As a quality assurance specialist, one is responsible for maintaining and adhering to company and regulatory compliance requirements when carrying out quality system programs by performing internal audits, hosting client audits and providing assistance during inspections.
- Maintaining the Internal Audit Program and Supplier / Material Qualification Program by performing internal and supplier audits to evaluate compliance to standard operating procedures.
- Responsible for tracking and follow up of internal and supplier audit observations to assure timely closure.
- Assisting with monitoring and communication of supplier change communication with suppliers for non-conformance and complaint handling
- Assist with client audits and organizing audit responses for any deficiencies from internal stakeholders.
- Providing assistance to others as needed with tasks that require a high level of understanding of quality systems
- Drafting, review and management of supplier QAA's and non-disclosure agreements as well as metrics
- Provide support for Quality Council meetings
- Provides support during FDA and other regulatory agency inspection procedures
- Facilitate internal training on GMP
- Training of regulatory requirements, processes and procedures as needed
- Complete assignments with minimal supervision needing minimal direction when performing tasks
Skills and Experience:
- 5+ Years of experience in QA GMP in a pharmaceutical/biotech/medical environment
- Organizational skills
- Detail oriented
- Experience working with cross-functional teams,
- Excellent interpersonal skills and the ability to communicate well orally and in writing.
- Thorough working knowledge of FDA regulations
- Ability to multi-task in a dynamic environment and meet set timelines thinking strategically and technically.
- Auditing certification preferred (i.e., ASQ, CQA or similar)