The Specialist, Quality Assessment has responsibility for the day-to-day management of the internal/external audit and GMP training programs at Nuron Biotech. The successful candidate reports to/works closely with the Associate Director, Quality Systems to develop, implement, maintain, and communicate outputs of these quality system programs as well as related key quality indicators (metrics).
ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. Other duties may be assigned.
Assist in the development, implementation and compliant execution of quality system programs/processes such as:
Develop, implement and execute a revision controlled annual internal and external audit schedule; changes to the schedule are to be documented and approved.
Ensure that the audits are scheduled, performed and documented in accordance with established procedures, guidance documents and templates.
Ensure that corrective and preventive actions associated with audit evens are obtained, reviewed and approved in a timely manner.
Develop, implement, and communicate performance data (i.e., “voice of the process” metrics) related to the Internal/External Audit Program and periodic GMP training.
Participate in support of CMO selection and oversight as required.
Assist in providing GMP training, including annual GMP refresher training, for Nuron Biotech employees and select GMP service providers.
Lead or participate in audit events, both domestic and international, as required (up to 25%).
- CMO Selection and Oversight
- Internal/External Audit Program
- GMP Training
- Key Quality Indicator (metric) Reporting
The Specialist, Quality Assessment has no direct reports however he/she may be required to lead/participate and coordinate diverse teams.
The Manager, Quality Assessment must be knowledgeable and capable in the following areas:
cGMP and FDA/EMA biologics regulations, and as applicable other international regulations
Aseptic Processing regulations and guidelines. Must be able to evaluate manufacturing conditions and lot-specific data in order to disposition products
Production of biological products
Process and analytical validation
Change management, document control, deviations management, training (including record keeping) and CAPA
Analysis and problem solving – Must have the ability to review and analyze manufacturing, quality control and validation data. Participates on, and leads as necessary, cross-functional teams in root cause analysis and solution identification.
Developing effective corrective and preventive actions
Experience with validation of electronic Quality System databases.
EDUCATION and/or EXPERIENCE
Bachelor's Degree in a scientific discipline, or health related field.
Minimum of 5 years hands-on experience in a GMP environment in a global pharmaceutical or biotechnology environment
Minimum of 3 years hands-on experience in Quality Assurance/Quality Control in a global pharmaceutical or biotechnology environment
A great co-worker and team player
Strong attention to detail
Thrives in a dynamic work environment
Able to manage multiple priorities
Ability to exercise judgment to determine appropriate corrective actions
Nuron Biotech - 13 months ago
Nuron Biotech is developing novel biologics and vaccines for the prevention and treatment of neurodegenerative and infectious diseases. Our...