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 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 equitableculture 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 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. 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 part owner in Maravai through RSU grants and optional employee stock purchase plans.  We offer comprehensive medical plans and 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.  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  Benefits & growth site at   https://www.maravai.com/careers/benefits-and-growth/   To view more opportunit