QA Operations Specialist II

Who we are:

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 worlds leading biopharma vaccine diagnostics and cell and gene therapy companies.

At Maravai we believe that diverse perspectives are the foundation of 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 togetherprovidingdifferentiated value to our customers and enabling the miracles of over 35 yearsMaravaisportfolio 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.

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.

How you will make an impact:

• Responsible for reviewing and approving Quality Events (e.g.discovery eventsandCAPAs) to ensureappropriate investigationsarecompletedina timely manner.
• Provideoversight forquality operationstrainingprogramandconductsquality related training.
• Conductquality investigations to assess root cause corrections corrective actions preventive actions andmonitor of quality tools such as 5-Whys FMEAs DMAIC Cause and Effect Diagrams Process Mapping etc.
• Leadcross-functional teams in risk identification and mitigation activities.
• Reviewandapproveproduct documentation for disposition of finished goods.
• Reviewand approvechange controlsof materials equipment processes and procedures includingappropriate documentation.
• Maintainthe control of documents and records.
• Assurecompliance with all in-house or external specifications to standards such as ISO or customer requirements.
• Workwith various functions including Manufacturing QC R&D commercial customer service technical support facilities IT etc. to continuously improveQualityOperations.
• LeadQuality improvement projects.
• Identifyquality issues/discrepancies and effectivelyresolvetheseissueswithin the organization.
• Managedocumentchangeorders and work with respective manufacturing and other teams to update procedures work instructions and forms as.
• Review stability protocols andpacketsas necessary.
• Reviewfinishedgood specifications.
• Participatein project initiatives at the site as a quality representative.
• Participate in internal and external audits as.
• Ensure compliance with GDP practices.
• Promote a culture of quality compliance continuous improvement andinspectionreadiness throughout the organization.
• Perform other functions and duties as.

The skills and experience that you will bring:

• MinimumBachelors Degreein scientific discipline (Chemistry Biology Bioengineering etc.).
• Quality professional with a minimum of 5 years relevant experience ina lifescience industry.
• Requires knowledge of ISO 9001 standards (or ISO 13485).
• Strong and effective verbal and written communication skills.
• Strong interpersonalteamworkand customer interfacing skills.
• Strong problem-solving skills and analytical skills applied to investigations.
• Self-motivated and able to organize and prioritize multiple tasks.
• Ability toidentifyquality issues/discrepancies and effectively resolve discrepancies within the organization.
• Proficient in Microsoft Office.
• Experience with NetSuite ERP andMasterControlis a plus.

The anticipated salary range for this position is $60000 - $70000. 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 candidates 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 changeimprove 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.
• Retirementcontributions.
• Holidays & Paid Time Off.

Benefits may vary by region and employment type and do not apply to temporary employees or contractors. See a comprehensive list of benefits at ourBenefits & growthsite at viewmoreopportunitiesto become a #MiracleMakervisitour career site at is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race color religion sex including sexualorientationand gender identity national origin disability protected Veteran Status or any other characteristic protected by applicable federal state or local law.

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Recently individuals impersonating Maravai LifeSciences Human Resources members have offered fraudulent interviews and job offers to unsuspecting candidates. To help protect you from thesescamartists please be aware that:

• Maravai LifeSciences will never interview a candidate over RingCentral similar messaging apps or social media (e.g. Telegram Google Hangouts WhatsApp Facebook Messenger etc.)
• 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.
• Maravai LifeSciences will never provide excess money to an applicant and ask the applicant to write a check for repayment.

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 . Ifyoubelieve you have been a victim of fraud you can report this activity at:.