Sr. QA Specialist
In this role, the person will be responsible for ensuring product quality at local site while developing and maintaining relationships. Leading by influence, the individual must be well organized and have excellent oral and written communication skills to effectively interact with external Suppliers to ensure client’ s quality compliance needs are met in a timely manner.
This includes collaborative interactions such as due diligence, establishing and maintaining quality agreements, review of change controls, deviations, batch review and disposition and metrics as well as providing support to build effective internal quality systems and supporting continuous improvement activities.
This individual will work closely with internal manufacturing, Quality Control, regulatory, quality systems, and the clinical supply chain operations teams to maintain drug product supply.
He or She will be responsible for QMS validation and implementation. The Senior Quality Assurance Specialist will also be responsible for supporting the management vendor qualification and self-inspection.
- Minimum of 3 years pharmaceutical quality experience in a GMP manufacturing and supply chain environment. Knowledge of CDER and CDRH regulations is a plus.
- Minimum, a BS degree in life sciences, engineering or related field.
- developing and maintaining quality metrics.
- Support technology transfers, analytical method transfers, and process validation in a quality role
- Review of event documentation such as Batch records, Lot history record, Deviation investigations, Change Controls,
- Review vendor protocols and reports
- Attend routine business meetings as the quality representative
- Supporting audits and inspections
- Perform functions and makes decision consistent with cGMPs, GDPs and Lyra's quality governance
- Good understanding of FDA and EMA regulations and guidelines
- Good understanding of CMO mediated Supply Chain activities
- Excellent organizational, communication, and interpersonal skills.
- Represent Quality on product development teams to ensure adherence to company procedures and applicable US and OUS regulatory requirements
- Ensure implementation of Design Controls throughout product life cycle
- Working knowledge of the US and International standards governing the design, development and manufacture of medical devices
- Experience developing combination products under ISO and GMP procedures
• Six Sigma certification a plus
• Develop, implement, and perform following quality functions:
• Document control
• Change control
• Equipment calibration and preventive maintenance
• Training systems
• Supplier management for the approved vendor list
• Incoming inspection and development of acceptance controls
• Disposition of non-conforming materials
• Data review
• Management reviews
• Quality plans
• Investigations and CAPAs
• Internal audits
• External vendor audits
• Risk management related documents, including FMEAs and PHAs
• Production and process controls
• Support manufacturing builds