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Aktif
Ofis
San Diego, CA
Yayınlandı · 20.09.2026
Greenhouse (US)

# QA Operations Specialist II

Maravai LifeSciences

Who we are:&nbsp; 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.&nbsp;&nbsp; At Maravai, we believe that diverse perspectives are the foundation of innovation.&nbsp;Through an inclusive and&nbsp;equitableculture where every team member is inspired to bring their best selves to work, we cultivate an environment in which we can lead together,&nbsp;providing&nbsp;differentiated value to our customers, and enabling the miracles of science.&nbsp;For over 35 years,&nbsp;Maravai’s&nbsp;portfolio companies have served as a catalyst for innovative, lifesaving technology for humanity. Pioneering nucleotide research since its&nbsp;inception, we are now leading the way in the rapidly expanding mRNA market.&nbsp;Your next role as a Miracle Maker&nbsp; 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.&nbsp; 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:&nbsp; Responsible for reviewing and approving Quality Events (e.g. discovery events&nbsp;and&nbsp;CAPAs) to ensure appropriate investigations are completed&nbsp;in&nbsp;a timely manner.&nbsp; Provide&nbsp;oversight for&nbsp;quality operations&nbsp;training&nbsp;program&nbsp;and&nbsp;conducts&nbsp;quality related training. &nbsp; Conduct&nbsp;quality investigations to assess root cause, corrections, corrective actions, preventive actions, and&nbsp;monitor&nbsp;effectiveness.  Use of quality tools, such as 5-Why's, FMEA's, DMAIC, Cause and Effect Diagrams, Process Mapping, etc. &nbsp; Lead&nbsp;cross-functional teams in risk identification and mitigation activities. &nbsp; Review&nbsp;and&nbsp;approve&nbsp;product documentation for disposition of finished goods. &nbsp; Review&nbsp;and approve&nbsp;change controls&nbsp;of materials, equipment, processes, and procedures including&nbsp;appropriate documentation.&nbsp; Maintain&nbsp;the control of documents and records.&nbsp; Assure&nbsp;compliance with all in-house or external specifications to standards such as ISO or customer requirements.                                                                                                                                           &nbsp; Work with various functions, including Manufacturing, QC, R&amp;D, commercial, customer service, technical support, facilities, IT, etc. to continuously improve&nbsp;Quality&nbsp;Operations.&nbsp; Lead&nbsp;Quality improvement projects. &nbsp; Identify&nbsp;quality issues/discrepancies and effectively&nbsp;resolve&nbsp;these&nbsp;issues&nbsp;within the organization. &nbsp; Manage&nbsp;document&nbsp;change&nbsp;orders and work with respective manufacturing and other teams to update procedures, work instructions, and forms as&nbsp;required.&nbsp; Review stability protocols and&nbsp;packets&nbsp;as necessary.&nbsp; Review&nbsp;finished&nbsp;good specifications.&nbsp; Participate&nbsp;in project initiatives at the site as a quality representative.&nbsp; Participate in internal and external audits as&nbsp;required.&nbsp; Ensure compliance with GDP practices.&nbsp; Promote a culture of quality, compliance, continuous improvement, and&nbsp;inspection&nbsp;readiness throughout the organization.&nbsp; Perform other functions and duties as&nbsp;required.&nbsp; &nbsp;The skills and experience that you will bring:&nbsp; Minimum, Bachelor's Degree&nbsp;in scientific discipline (Chemistry, Biology, Bioengineering, etc.). &nbsp; Quality professional with a minimum of 5 years relevant experience in&nbsp;a life&nbsp;science industry. &nbsp; Requires knowledge of ISO 9001 standards (or ISO 13485).&nbsp; Strong and effective verbal and written communication skills. &nbsp; Strong interpersonal,&nbsp;teamwork,&nbsp;and customer interfacing skills. &nbsp; Strong problem-solving skills and analytical skills applied to investigations. &nbsp; Self-motivated and able to organize and prioritize multiple tasks. &nbsp; Ability to&nbsp;identify&nbsp;quality issues/discrepancies and effectively resolve discrepancies within the organization.  &nbsp; Proficient in Microsoft Office.&nbsp; Experience with NetSuite ERP and&nbsp;MasterControl&nbsp;is a plus.&nbsp; 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. &nbsp; #LI-OnsiteThe benefits of being a #MiracleMaker:&nbsp; You have the potential to change,&nbsp;improve, and save lives around the world.&nbsp; You have the opportunity to be a part&nbsp;owner in&nbsp;Maravai through RSU grants and&nbsp;optional&nbsp;employee stock purchase plans.&nbsp; We&nbsp;offer comprehensive&nbsp;medical plans&nbsp;and&nbsp;HSA/FSA&nbsp;options.&nbsp; Fertility &amp;&nbsp;family planning&nbsp;assistance.&nbsp; A variety of&nbsp;additional&nbsp;optional benefits&nbsp;and insurance options, including&nbsp;pet insurance.&nbsp; Retirement&nbsp;contributions.&nbsp; Holidays &amp; Paid Time Off.&nbsp; 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&nbsp;Benefits &amp; growth site at&nbsp;https://www.maravai.com/careers/benefits-and-growth/&nbsp; To view&nbsp;more&nbsp;opportunities&nbsp;to become a #MiracleMaker,&nbsp;visit&nbsp;our career site at&nbsp;&nbsp;https://www.maravai.com/careers/&nbsp;&nbsp; Maravai&nbsp;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&nbsp;orientation,&nbsp;and gender identity, national origin, disability, protected Veteran Status, or any other characteristic protected by applicable federal, state, or local law.&nbsp; Click here to view Maravai LifeSciences Privacy Notice&nbsp; &nbsp; HIRING SCAM ALERT&nbsp; Recently, individuals impersonating Maravai LifeSciences Human Resources members have offered fraudulent interviews and job offers to unsuspecting candidates. To help protect you from these&nbsp;scam&nbsp;artists, please be aware that:&nbsp; Maravai LifeSciences will never interview a candidate over RingCentral, similar messaging apps or social media (e.g. Telegram, Google Hangouts, WhatsApp, Facebook Messenger, etc.)&nbsp; Maravai LifeSciences will never send a company check or ask an applicant to pay a fee or purchase at home work/training materials in connection with an application for employment.&nbsp; Maravai LifeSciences will never provide excess money to an applicant and ask the applicant to write a check for repayment.&nbsp;  If you have any doubt about a job offer or any other communication purporting to come from Maravai LifeSciences, please reach out to us directly at taops@maravai.com. If&nbsp;you&nbsp;believe you have been a victim of fraud, you can report this activity at:&nbsp;www.iC3.gov&nbsp;or&nbsp;www.stopfraud.gov.&nbsp;

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