QA Operations Specialist II

Maravai and Kirkland & Ellis LLP; San Diego (CA); On-site; USD 60,000 - 70,000; Full time

Benefits offered by this job

RSU grants

Employee stock purchase plan

Medical plans

Fertility assistance

Pet insurance

Job summary

Maravai LifeSciences is seeking a QA Operations Specialist II to join the Quality Assurance team. This role focuses on maintaining and improving the Quality Management System, reviewing deviations, NCRs, CAPAs, supplier management, and change controls, with alignment to ISO 9001:2015.

You will lead cross-functional quality initiatives, review product documentation, ensure GDP compliance, and mentor quality training, working with Manufacturing, QC, R&D, and IT to strengthen operations.

Qualifications

• Bachelor's degree in a scientific discipline.
• Minimum 5 years of life science QA experience.
• Knowledge of ISO 9001 standards (or ISO 13485).
• Strong verbal and written communication skills.
• Strong interpersonal, teamwork, and customer interfacing skills.
• Proficiency in Microsoft Office.
• Experience with NetSuite ERP and MasterControl is a plus.

Responsibilities

• Review and approve quality events, investigations, and CAPAs.
• Oversee quality operations training and conduct quality-related training.
• Perform quality investigations to identify root causes and verify effective CAPAs.
• Lead cross-functional risk identification and mitigation activities.
• Review and approve product documentation and change controls.
• Maintain document control and records management.
• Ensure compliance with ISO 9001 and GDP standards.

Skills

Quality Assurance

ISO 9001 Knowledge

Communication Skills

Teamwork

Problem Solving

Documentation & Records

Education

Bachelor's Degree in Life Science

Tools

NetSuite ERP

MasterControl

Job description

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 andequitableculture where every team member is inspired to bring their best selves to work, we cultivate an environment in which we can lead together,providingdifferentiated value to our customers, and enabling the miracles of science.For over 35 years,Maravai’sportfolio companies have served as a catalyst for innovative, lifesaving technology for humanity. Pioneering nucleotide research since itsinception, we are now leading the way in the rapidly expanding mRNA market.

Maravai LifeSciences is seeking a #MiracleMaker to join our Quality Assurance team as a QA Operations Specialist II . The QA Operations Specialist II is r esponsible 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.

Your next role as a Miracle Maker

How you will make an impact:

• Responsible for reviewing and approving Quality Events ( e.g. d iscovery events and CAPAs ) to ensure appropriate investigations are completed in a timely manner .
• Provide oversight for quality operations training program and conduct s quality related training .
• Conduct 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.
• Lead cross-functional teams in risk identification and mitigation activities.
• Review and approve product documentation for disposition of finished goods.
• Review and approve change control s of materials, equipment, processes, and procedures in cluding appropriate documentation .
• Maintai n the control of documents and records.
• Assure 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 Quality Operations .
• Lead Quality improvement projects.
• Identif y quality issues / discrepancies and effectively resolve these issues within the organization.
• Ma nage document change orders and work with respective manufacturing and other teams to update procedures, work instructions, and forms as required .
• Review stability protocols and packets as necessary .
• Review finished good specifications .
• Participate in project initiatives at the site as a quality representative .
• Participate in internal and external audits as required .
• Ensure compliance with GDP practices .
• Promote a culture of quality, compliance, continuous improvement, and inspection readiness throughout the organization.
• Perform other functions and duties as required .

The skills and experience that you will bring:

• 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 .
• Experience with NetSuite ERP and MasterControl is a plus .

The anticipated salary range for this position is $60,000 - $70,000. 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.

#LI-Onsite

The benefits of being a #MiracleMaker:

• You have the potential to change,improve, and save lives around the world.
• You have the opportunity to be a partowner inMaravai through RSU grants andoptionalemployee stock purchase plans.
• Weoffer comprehensivemedical plansandHSA/FSAoptions.
• Fertility &family planningassistance.
• A variety ofadditionaloptional benefitsand insurance options, includingpet insurance.

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