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 andequitableculture where every team member is inspired to bring their best selves to work, we cultivate an environment in which we can lead together,providingdifferentiated value to our customers, and enabling the miracles of science.For over 35 years,Maravai'sportfolio 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 Manager, QA Operations. The Manager, QA Operationsis responsible for the implementation of policies and procedures to ensure adherence to production quality standards and oversight of the Company's electronic ISO 13485:2016 Quality Management System. The Quality Assurance Manager is expected to ensure compliance with operational, statutory, and regulatory requirements in support of the Company's business objectives.
How you will make an impact:
- Manage Quality Assurance department day to day operations, including implementing training and performance management activities for direct reports
- Implement and periodically evaluate documentation and policies to ensure continuous compliancetothe quality, integrity, and efficiency standards set by the organization, the ISO 13485:2016 standard, and other statutory and regulatory requirements.
- Collaborate with management toidentifyand fill documentation and process gapsrequiredto maintain QMS compliance and address CAPAs, NCs, and audit findings
- Author andmaintainquality documentation, overseetimelyreviews of all work instructions associated with production and quality control activities
- Support Quality Control with customer complaints and Out of Specification (OOS) investigations
- Activelyparticipateon core teams and provide deliverables from QA on quality processes andrequireddocumentation practices from production through testing and shipment
- Implement and track metrics tomonitorperformance associated with Quality management
- Identifyand implement efficiency improvement initiatives in support of Continuous Improvement
- Facilitate proactive solutions by collecting and analyzing quality data
- Manage Internal Audit Program
- Perform other functions and duties asrequired
The skills and experience that you will bring:
- Bachelor's Degree in Life Science, Biology, Chemistry or Pharmaceutical or related discipline
- 3-5 years of managerial experience in non-academic biotechnology related industry
- 1-3 years of supervisory experience
- Proven experience with: ISO 13485 certification, federal regulations 21 CFR 820 and 21 CFR Part 11
- Industry experience in a Good Manufacturing Practice (GMP) environment is preferred
- Thorough knowledge of analytical testing industry standards and quality assurance methodologies
- Excellent communication and presentation skills arerequired
- Demonstrated scientific "problem solving" skills, translated into consultative selling process where the "win" is for both the client and the company
- Ability toparticipatewith others as a member of the team to ensure that demanding and difficult projects are handled smoothly and cooperatively to enhance success of project andmaintainstrong relationships within all parts of company
- Proven ability to thrive in a start-up/change oriented environment
- Great attention to detail and results driven approach
- Self-starter with ability to organize and prioritize a diverse set of responsibilities to ensure that focus on growth and success of company is achieved
- Proven coaching, mentoring, teambuildingand leadership skills
#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 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 & growth site athttps://www.maravai.com/careers/benefits-and-growth/
To viewmoreopportunitiesto become a #MiracleMaker,visitour career site athttps://www.maravai.com/careers/
MaravaiLifeSciences is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex including sexualorientation,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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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 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:www.iC3.govorwww.stopfraud.gov.
