Key Role:

Provide consistent support that meets customer and applicable regulatory requirements, through the effective application of a Quality Management System (QMS), including processes for continual improvement. Assist with and lead designing, developing, centralizing, and sustaining a streamlined QMS while supporting to achieve and maintain ISO 9001:2015 certification or similar. Leverage expertise in quality standards that may include ISO 9001, ISO 13485, ICH Q10, 21 CFR Part 820, and 21 CFR Part 11. Develop a strategy related to long term implementation and sustainment of a quality management system. Work on a comprehensive quality management system that ensures recognized standards and oversight mandates are adhered to while enhancing the reliability, reproducibility, and timely collation and production of data. Apply expertise in the implementation of quality management systems that ensure accredited regulatory compliance.

Basic Qualifications:

• 3+ years of experience in working with a certified quality management system and quality standards, including ISO 9001:2015 and ISO 13485
• 3+ years of experience with leading quality assurance (QA) and Quality Control activities writing SOPs, validation plans, and IQ, OQ, and PQ plans
• 3+ years of experience with conducting internal and external audits and assessments
• 3+ years of experience with identifying, developing, and monitoring Key Performance Indicators and Critical Success Factors
• Ability to communicate concepts of quality management and process improvement
• Ability to obtain a security clearance
• BA or BS degree

Additional Qualifications:

• Experience with an eQMS or LIMS
• Experience with managing a quality management system and achieving certification
• Experience with change management and organizational excellence
• Ability to manage and execute multiple tasks, prioritize, and meet deadlines
• Ability to work in a team environment that promotes inclusiveness and communication among team members while being a self-starter
• BA or BS degree in Biological Science, Microbiology, Biotechnology, Biomolecular Engineering, or a related field
• Certified Quality Auditor, ISO Lead, or a related quality-associated certification

Clearance:

Applicants selected will be subject to a security investigation and may need to meet eligibility requirements for access to classified information.

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