Senior QA Operations Specialist

Maravai LifeSciences • San Diego, CA

5h • Onsite

About The Position

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.
Your next role as a Miracle Maker
Maravai LifeSciences is seeking a #MiracleMaker to join our Quality Assurance team as a Senior QA Operations Specialist. As a Senior QA Operations Specialist, you will be responsible for leading the maintenance and continuous improvement of the Quality Management System. Includes the review and approval of deviations, NONCs, 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.

Requirements

• Minimum, Bachelor's Degree in scientific discipline (Chemistry, Biology, Bioengineering, etc.).
• Quality professional with a minimum of 5 years relevant experience in a life science industry.
• Requires knowledge of ISO 9001 standards (or ISO 13485) and Good Manufacturing Practices.
• Knowledge of root cause analysis tools, such as 5-Why's, FMEA's, DMAIC, Cause and Effect Diagrams, Process Mapping, etc.
• Strong and effective verbal and written communication skills.
• Strong interpersonal, teamwork and customer interfacing skills.
• Strong problem-solving skills and analytical skills applied to investigations.
• Self-motivated and able to organize and prioritize multiple tasks.
• Ability to identify quality issues/discrepancies and effectively resolve discrepancies within the organization.
• Proficient in Microsoft Office.

Nice To Haves

• Experience with NetSuite ERP and MasterControl is preferred.

Responsibilities

• Reviews and approves product documentation for production and disposition of finished goods.
• Reviews and approves change control of materials, equipment, processes, and procedures and reviews the execution of change controls, as appropriate.
• Identifies quality issues/ discrepancies and effectively resolves these within the organization.
• Responsible for reviewing and approving Quality Events (e.g. Discovery events, deviations, NONCs, CAPAs, and complaints) to ensure appropriate investigations are thorough and completed in a timely manner.
• Conducts quality investigations to assess root cause, corrective actions, preventive actions, and monitor effectiveness.
• Provides oversight for training junior team members and conduct quality related training as it applies to their responsibilities.
• Leads cross-functional teams in risk identification, implementation of mitigation actions, and quality improvement projects.
• Compiles, trends, maintains, reports, and presents quality metrics during site Management Reviews to ensure visibility of QMS health.
• Supports 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.
• Supports supplier quality by ensuring approved suppliers are used in operation.
• Perform other functions and duties as required.

Benefits

• You have the potential to change, improve, and save lives around the world.
• You have the opportunity to be a part owner in Maravai through RSU grants and optional employee stock purchase plans.
• We offer comprehensive medical plans and HSA/FSA options.
• Fertility & family planning assistance.
• A variety of additional optional benefits and insurance options, including pet insurance.
• Retirement contributions.
• Holidays & Paid Time Off.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level