The Quality Assurance Specialist II is responsible for supporting the quality system processes including Internal Audits, CAPAs, Document Control, and Supplier Quality audits.
Essential Duties and Responsibilities:
- Responsible for maintaining quality assurance standards, processes and controls. Develops and implements methods for inspection, testing, sampling, and training.
- Support quality assurance programs, processes and facilities by ensuring compliance with regulatory, internal and client requirements in the manufacture of products.
- Assist with implementation and training of all employees regarding the quality system and overall compliance with the corporate quality manual.
- Expected to be familiar with all of Aldevron's products and services and all associated systems with a good understanding of molecular biology, microbiology, biochemistry and cell biology.
- Identifies compliance risks at Aldevron through auditing process
- Support of the CAPA system by:
- Ensuring all events are adequately investigated
- Appropriate CAPA actions are put into place
- Records are closed within a timely manner
- Support of Aldevron's internal audit program to ensure processes are performed in accordance with written procedures and other applicable external requirements and appropriately and adequately identifying and prioritizing internal risks through the internal audit process and ensure deficiencies are addressed which includes:
- Performance of internal audits as scheduled, maintaining documentation as required
- Performance of in-process audits as scheduled, maintaining documentation as required
- Support of the qualification and monitoring of Aldevron's suppliers/vendors which includes:
- Performance of supplier quality audits as scheduled, maintaining documentation as required
- Support of maintaining the Document Control process by ensuring all quality records within the Document Control system are maintained effectively, which includes:
- Performance of document updates as scheduled, maintaining documentation as required
- Assignment of training to appropriate individuals
- Support Quality Assurance involvement in and review of change management and change control requests.
- Support GMP and GMP-S Manufacturing activities by:
- Perform technical and administrative review of batch and analytical data for accuracy and compliance with procedures for raw material, in-process and product release
- Oversight of room/equipment release for usage
- Active participation in the Environmental Monitoring program
- Review and approve QC product testing documentation supporting batch release
- Support of Aldevron's validation process by reviewing protocols, testing plans and final reports, as assigned, to meet internal SOPs and regulatory requirements.
- Provide support during external inspections performed of Aldevron by regulatory agencies /clients and leading corrective actions resulting from inspection findings:
- Assist in inspection readiness activities including, but not limited to: audit preparation activity, scheduling and ensuring performance of facility walk-through inspections, and ensuring adequate resources (conference rooms, general logistics, equipment, personnel etc) are available to support/host
- Assist in ensuring inspection responses and follow-up activities are performed as required which may include: ensuring that audit findings are appropriately addressed through corrective and preventive actions within agreed upon timeframes and ensuring all inspection follow-up activity is coordinated/performed
- All employees are responsible for the general upkeep of work and shared spaces.
- Other duties as assigned.
Aldevron is a custom manufacturing organization that provides plasmid, protein and antibody development and production services. Headquartered in Fargo, ND with locations in Madison, WI and Freiburg, Germany we constantly look to innovate and advance life science through collaborative partnerships. Aldevron works with leaders in pharmaceutical, biotech and research institutions around the world to accelerate the development of drug, treatment and preventions for numerous diseases and genetic disorders. Our reputation for innovative solutions for our clients has allowed us to expand our organization and offerings in all service platforms. We are working in a landmark moment in the history of life science.