Maravai LifeSciences
Senior QA Operations Specialist
Maravai LifeSciences, San Diego, California, United States, 92189
Join to apply for the
Senior QA Operations Specialist
role at
Maravai LifeSciences .
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.
Who we are
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 where we can lead together. 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 QA Operations team as a Senior QA Operations Specialist. As a Senior QA Operations Specialist, you'll be responsible for leading the maintenance and continuous improvement of the Quality Management System, including the review and approval of deviations, NCRs, CAPAs, supplier management, change controls, and controlled documentation management. You will also provide review and approval for products and new product development documentation, track and report on quality metrics, and ensure compliance with company policies and procedures and applicable domestic and international standards and regulations, including 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 conducts quality related training
Conducts quality investigations to assess root cause, corrective actions, and preventive actions, and monitor effectiveness using quality tools such as 5‑Why’s, FMEA’s, DMAIC, Cause and Effect Diagrams, and Process Mapping
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)
Ensures compliance with all in‑house or external specifications to standards such as ISO or customer requirements
Works with various functions—Manufacturing, QC, R&D, commercial, customer service, technical support, facilities, IT—to continuously improve the Quality Management System
Supports supplier quality by maintaining the approved supplier list, administering supplier surveys, quality agreements, and performing critical supplier audits as needed
Leads quality improvement projects and identifies quality issues/discrepancies, resolving them within the organization
Performs other functions and duties as required
The skills and experience that you will bring
Minimum, Bachelor’s Degree in a scientific discipline (Chemistry, Biology, Bioengineering, etc.)
Quality professional with a minimum of five years relevant experience in a life science industry
Knowledge of ISO 9001 standards (or ISO 13485)
Strong verbal and written communication skills
Strong interpersonal, teamwork and customer interfacing skills
Strong problem‑solving and analytical skills applied to investigations
Self‑motivated, able to organize and prioritize multiple tasks
Proficient in Microsoft Office
Experience with NetSuite ERP and MasterControl is a plus
Compensation The anticipated salary range for this position is $102,000- $115,000. 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, including the successful candidate’s skills, experience and other qualifications, as well as the location of the role.
Benefits
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/
Equal Opportunity 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.
Privacy Notice 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 taops@maravai.com. If you believe you have been a victim of fraud, you can report this activity at www.iC3.gov or www.stopfraud.gov.
#J-18808-Ljbffr
Senior QA Operations Specialist
role at
Maravai LifeSciences .
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.
Who we are
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 where we can lead together. 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 QA Operations team as a Senior QA Operations Specialist. As a Senior QA Operations Specialist, you'll be responsible for leading the maintenance and continuous improvement of the Quality Management System, including the review and approval of deviations, NCRs, CAPAs, supplier management, change controls, and controlled documentation management. You will also provide review and approval for products and new product development documentation, track and report on quality metrics, and ensure compliance with company policies and procedures and applicable domestic and international standards and regulations, including 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 conducts quality related training
Conducts quality investigations to assess root cause, corrective actions, and preventive actions, and monitor effectiveness using quality tools such as 5‑Why’s, FMEA’s, DMAIC, Cause and Effect Diagrams, and Process Mapping
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)
Ensures compliance with all in‑house or external specifications to standards such as ISO or customer requirements
Works with various functions—Manufacturing, QC, R&D, commercial, customer service, technical support, facilities, IT—to continuously improve the Quality Management System
Supports supplier quality by maintaining the approved supplier list, administering supplier surveys, quality agreements, and performing critical supplier audits as needed
Leads quality improvement projects and identifies quality issues/discrepancies, resolving them within the organization
Performs other functions and duties as required
The skills and experience that you will bring
Minimum, Bachelor’s Degree in a scientific discipline (Chemistry, Biology, Bioengineering, etc.)
Quality professional with a minimum of five years relevant experience in a life science industry
Knowledge of ISO 9001 standards (or ISO 13485)
Strong verbal and written communication skills
Strong interpersonal, teamwork and customer interfacing skills
Strong problem‑solving and analytical skills applied to investigations
Self‑motivated, able to organize and prioritize multiple tasks
Proficient in Microsoft Office
Experience with NetSuite ERP and MasterControl is a plus
Compensation The anticipated salary range for this position is $102,000- $115,000. 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, including the successful candidate’s skills, experience and other qualifications, as well as the location of the role.
Benefits
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/
Equal Opportunity 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.
Privacy Notice 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 taops@maravai.com. If you believe you have been a victim of fraud, you can report this activity at www.iC3.gov or www.stopfraud.gov.
#J-18808-Ljbffr