Temporary QA 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 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 Temporary QA Specialist. As a Temporary QA Specialist you will support quality operations functions by identifying and analyzing emergent trends and existing points of non-compliance/inefficiency to drive continuous improvement. Support GMP batch release activities through review, oversight of associated quality events (OOS, NCMR, DEV), and disposition. Ensure compliance with company policies and procedures and applicable domestic and international standards and regulations.

How you will make an impact:

• Responsible for collaborating with GMP batch review personnel to identify areas of improvement, both within QA and in other stakeholder departments (e.g. manufacturing or QC)

• Responsible to implement continuous improvement through MOC, DCO, or other change management processes

• Responsible for developing and maintaining tracking mechanisms to allow for quality event trending. Upon identification of adverse trends, collaborates with stakeholder departments to implement actions that will mitigate or eliminate the trend(s)

• Responsible for reviewing and approving GMP batch records and associated documentation required for GMP final product release

• Responsible for generating COOs and CORs in support of GMP batch release

• Review and approve COAs in support of GMP batch release

• Responsible for initiating and reviewing Quality Events (e.g. Deviations, NCMRs, CAPA and OOSs) when assigned by a Quality Assurance Manager

• Assist in conducting 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, Cause and Effect Diagrams, Process Mapping, etc.

• Assure compliance with all in-house or external specifications to standards, such as ISO and GMP regulations

• Work with various functions, including Manufacturing, QC, R&D, commercial, customer service, technical support, facilities, IT, etc. to continuously improve the Quality Management System.

• Perform other functions and duties as required

The skills and experience that you will bring:

• Bachelor's Degree in scientific discipline (Chemistry, Biology, Bioengineering, etc.) or equivalent experience

• Quality professional with 4-6 years relevant experience in a life science industry

• Knowledge of ISO 9001 standards (or ISO 13485) and cGMP regulations (e.g. ICH Q7, or 21 CFR 210, 211 or 21 CFR 820) required

• 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

The anticipated salary range for this position is $27.00 - $34.00 per hour. 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.

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.

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.

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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 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.