Sr. Staff QA Operations Specialist

Posted 17 Hours Ago
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San Diego, CA
Senior level
Biotech
The Role
The Senior Staff QA Operations Specialist leads GMP Quality Operations, ensuring compliance with quality standards, conducting investigations, and training personnel to maintain quality standards.
Summary Generated by Built In

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 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, 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 Senior Staff Quality Assurance Operations Specialist. In this role you will be responsible for activities underneath the GMP Quality Operations function, including client liaison, project improvement initiatives, and approval of quality events (e.g., deviations, nonconformances, etc.).  You will be a quality point of contact for internal and external customers and ensure compliance with company policies and procedures and applicable domestic and international standards and regulations.

How you will make an impact: 

  • Lead and oversee GMP Quality Operations projects to ensure company quality objectives are met.
  • Drive and execute quality initiative that align with quality mission, vision, and goal.
  • Coach and train internal and external department personnel on maintaining the highest standards of quality and compliance; champion the promotion of a strong Quality Culture.
  • Act as the primary point of contact for quality-related matters for both internal and external customers.
  • Represent GMP QA Operations in cross-functional teams in risk identification and mitigation activities during risk management process.
  • Lead/Support quality investigations including deviations, nonconformances, and laboratory investigations, ensuring a thorough root cause analysis and effective corrective/preventive actions has been defined.
  • Cross-train to perform GMP QA Operations and Raw Material functions such as review, evaluate, and approve manufacturing room releases, production batch records, product releases, support raw material activities, etc.
  • Present GMP QA Operation processes in support of external quality audits (eg., customers, ISO, etc)
  • Develop, maintain, and communicate quality metrics to ensure visibility of QMS health.
  • Identify opportunities to improve quality, reduce cycle time, lower cost-of-goods, and increase operational efficiency.
  • Work with various functions, including Manufacturing, QC, T&D, commercial, customer service, technical support, facilities, IT, etc. to develop, implement, and continuously improve the Quality Management System
  • Perform other duties, as assigned.

 The skills and experience that you will bring: 

  • Minimum, Bachelor’s Degree in scientific discipline (Chemistry, Biology, Bioengineering, etc.)
  • Quality/GMP professional with a minimum of 10 years relevant experience in a life science industry
  • Minimum of 5 years of leadership experience
  • Requires knowledge of ISO 9001 (or ISO 13485) standards and cGMP regulations (e.g., 21 CFR 210/211)
  • Familiar with cleanroom operations (e.g., operating in a cleanroom, EM monitoring, validation, etc) is preferred but not required.
  • Understand Quality Event processes (deviation, non-conformance, OOS, CAPA, etc.)
    • Use of quality tools, such as 5-Why’s, FMEA’s, DMAIC, Cause and Effect Diagrams, Process Mapping, etc
  • Strong and effective verbal and written communication 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
  • Experience in supporting inspection readiness activities resulting in successful inspections

 The anticipated salary range for this position is $155,000- $165,000  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 opportunities to become a #MiracleMaker, visit our career site at https://www.maravai.com/careers/  

Maravai 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. 

Click here to view Maravai LifeSciences Privacy Notice 


HIRING SCAM ALERT 

Recently, individuals impersonating Maravai LifeSciences Human Resources members have offered fraudulent interviews and job offers to unsuspecting candidates. To help protect you from these scam artists, 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 [email protected]. If you believe you have been a victim of fraud, you can report this activity at: www.iC3.gov or www.stopfraud.gov. 

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The Company
HQ: San Diego, California
114 Employees
On-site Workplace
Year Founded: 2014

What We Do

Maravai brands set the standard in nucleic acid products and services, enzyme development, and biologics safety testing. From producing revolutionary mRNA technologies that drive infectious disease vaccines, cancer vaccines, and other cell and gene therapies to delivering gold-standard bioprocess impurity detection solutions, Maravai is helping life sciences companies overcome their biggest development and manufacturing challenges to streamline and scale from research through clinical trials to commercialization.

For over 35 years, Maravai’s brands have served as proven catalysts for innovative, lifesaving technology for humanity. Across our portfolio of brands, we hold numerous patents and offer more than 1,500 innovative products and services, including CleanCap® technology, CleanAmp® hot start PCR, Antibody Affinity Extraction™, EndonucleaseGTP®, PROTEIN A MIX-N-GO™, MockV®, Sterling™, Glen Pak™, Glen Gel-Pak™.

Each of our brands are ISO-9001:2015 certified and have earned hundreds of thousands of citations in peer-reviewed scientific publications.

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