Senior QA Operations Specialist

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 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 Maravais 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 QA Operations team as a Senior QA Operations Specialist. As a Senior QA Operations Specialists youll be responsible for leading 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. deviations NCRs CAPAs and complaints) to ensure appropriate investigations are completed timely
• Ensures change control of materials equipment processes procedures including appropriate documentation
• Maintains the control of documents and records
• 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-Whys FMEAs 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 reports and presents quality metrics during site Quality Management Reviews to ensure visibility of QMS health including creating trending graphs for weekly monthly and quarterly reports
• Leads the audit program including conducting internal audits and hosting external or third party quality audits (e.g. customers ISO etc.)
• Ensures compliance with all in-house or external specifications to standards such as ISO or customer requirements
• Works 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 resolves these within the organization
• Perform other functions and duties as required

The skills and experience that you will bring:

• Minimum Bachelors 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 $102000- $115000. 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 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 ourBenefits & growth site at view more opportunities to become a #MiracleMaker visit our career site at 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 orientation and gender identity national origin disability protected Veteran Status or any other characteristic protected by applicable federal state or local law.

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