Senior QA Operations Specialist

Senior QA Operations Specialist

Maravai LifeSciences translates extraordinary science into everyday miracles, helping biotech, biopharma, and life sciences companies everywhere deliver novel vaccines, therapeutics, and diagnostics. We are global leaders in providing products and services within the fields of nucleic acid production and biologics safety testing to many of the world's leading biopharma, vaccine, diagnostics, and cell and gene therapy companies. At Maravai, we believe that diverse perspectives are the foundation of innovation. Through an inclusive and equitable culture where every team member is inspired to bring their best selves to work, we cultivate an environment in which we can lead together, providing differentiated value to our customers, and enabling the miracles of science. For over 35 years, Maravai's portfolio companies have served as a catalyst for innovative, lifesaving technology for humanity. Pioneering nucleotide research since its inception, we are now leading the way in the rapidly expanding mRNA market.

Maravai LifeSciences is seeking a Miracle Maker to join our QA Operations team as a Senior QA Operations Specialist. As a Senior QA Operations Specialist, you'll be responsible for leading the maintenance and continuous improvement of the Quality Management System. Includes the review and approval of deviations, NCRs, CAPAs, supplier management, change controls, and controlled documentation management, etc. Provides review and approval for products and new product development documentation. Tracks and reports on quality metrics. Ensures compliance with company policies and procedures and applicable domestic and international standards and regulations, including but not limited to ISO 9001 : 2015.

How you will make an impact :

• Responsible for reviewing and approving quality events (e.g. deviations, NCRs, CAPAs, and complaints) to ensure appropriate investigations are completed timely
• Ensures change control of materials, equipment, processes, procedures including appropriate documentation
• Maintains the control of documents and records
• Provides oversight for training program and conduct quality related training
• Conducts quality investigations to assess root cause, corrections, corrective actions, preventive actions, and monitor effectiveness. Use of quality tools, such as 5-Why's, FMEA's, DMAIC, Cause and Effect Diagrams, Process Mapping, etc.
• Leads cross-functional teams in risk identification and mitigation activities
• Reviews and approves product documentation for disposition of finished goods
• Compiles, maintains, reports, and presents quality metrics during site quality management reviews to ensure visibility of QMS health, including creating trending graphs for weekly, monthly, and quarterly reports
• Leads the audit program, including conducting internal audits and hosting external or third party quality audits (e.g. customers, ISO, etc.)
• Ensures compliance with all in-house or external specifications to standards such as ISO or customer requirements
• Works with various functions, including manufacturing, QC, R&D, commercial, customer service, technical support, facilities, IT, etc. to continuously improve the Quality Management System
• Supports supplier quality by maintaining the approved supplier list, administering supplier surveys, quality agreements, approved supplier list, and performing critical supplier audits as needed
• Leads quality improvement projects
• Identifies quality issues / discrepancies and effectively resolves these within the organization
• Perform other functions and duties as required

The skills and experience that you will bring :

The anticipated salary range for this position is $102,000- $115,000. In addition, highly competitive long-term incentives in the form of company equity, bonus participation and company sponsored benefits are provided as part of the total compensation package. The salary offer will depend on multiple factors which may include the successful candidate's skills, experience and other qualifications, as well as the location of the role.

The benefits of being a Miracle Maker :

Benefits may vary by region and employment type and do not apply to temporary employees or contractors. See a comprehensive list of benefits at our Benefits & growth site.

Maravai LifeSciences is an Equal Opportunity / Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex including sexual orientation, and gender identity, national origin, disability, protected veteran status, or any other characteristic protected by applicable federal, state, or local law.