Staff QA Operations Specialist

Maravai LifeSciences • San Diego, CA

11h • $120,000 - $130,000 • 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 Staff QA Operations Specialist . As a Staff QA Operations Specialist, y ou will be responsible for activities within the Quality Operations function, including serving as a client liaison, leading project improvement initiatives, and reviewing and approving quality events (e.g., deviations, nonconformances, etc.). You will act as a key quality point of contact for internal and external customers and ensure compliance with company policies and procedures, as well as applicable domestic and international standards and regulations.

Requirements

• Minimum, Bachelor’s Degree in scientific discipline (Chemistry, Biology, Bioengineering, etc.)
• Quality/GMP professional with a minimum of 7 years relevant experience in a life science industry
• Requires knowledge of ISO 9001 (or ISO 13485) standards and cGMP regulations (e.g., 21 CFR 210/211)
• Understand Quality Event processes (deviation, non-conformance, OOS, CAPA, etc.) and use of quality 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 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
• Experience in supporting inspection readiness activities resulting in successful inspections

Nice To Haves

• Familiar with cleanroom operations (e.g., operating in a cleanroom, EM monitoring, validation, etc) is preferred but not required.

Responsibilities

• Lead and oversee Quality Operations projects to ensure company quality objectives are met.
• Drive and execute quality initiative that align with quality mission, vision, and goal.
• Coach and train internal and external department personnel on maintaining the highest standards of quality and compliance; champion the promotion of a strong Quality Culture.
• Act as a primary point of contact for quality-related matters for both internal and external customers.
• Represent QA Operations in cross-functional teams in risk identification and mitigation activities during risk management process.
• Lead/Support quality investigations including deviations, nonconformances, and laboratory investigations, ensuring a thorough root cause analysis and effective corrective/preventive actions has been defined.
• Cross-train to perform QA Operation functions such as review, evaluate, and approve manufacturing room releases, production batch records, product releases, support raw material activities, etc.
• Present QA Operation processes in support of external quality audits (eg., customers, ISO, etc)
• Develop, maintain, and communicate quality metrics to ensure visibility of QMS health.
• Identify opportunities to improve quality, reduce cycle time, lower cost-of-goods, and increase operational efficiency.
• Work with various functions, including Manufacturing, QC, T&D, commercial, customer service, technical support, facilities, IT, etc. to develop, implement, and continuously improve the Quality Management System.
• 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 o wner in Maravai through RSU grants and optional employee stock purchase plans .
• We offer comprehensive medical plans and H SA /FSA options .
• Fertility & family planning assistance .
• A variety of additional optional benefit s and insurance options, including pet insurance.
• Retirement contributions .
• Holidays & Paid Time Off .

What This Job Offers

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