QA Operations Specialist II

Maravai LifeSciences • San Diego, CA

33d • 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 QA Operations Specialist II. The QA Operations Specialist II is responsible for 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.

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)
• 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 a plus

Responsibilities

• 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 include appropriate documentation.
• Assists with document and record control functions as needed
• 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, and reports quality metrics to ensure visibility of QMS health, including creating trending graphs for weekly, monthly, and quarterly reports.
• Participates in the audit program, including conducting internal audits and external quality audits, as needed (e.g. customers, ISO, etc.).
• Assures compliance with all in-house or external specifications to standards such as ISO or customer requirements.
• Work 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 resolve these within the organization.
• Perform other functions and duties as required.

Benefits

• Highly competitive long-term incentives in the form of company equity
• Bonus participation
• Company sponsored benefits
• Comprehensive medical plans
• 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