Quality Engineer - Bioassay

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

Cygnus Techologies, a Maravai LifeSciences company, is seeking a #MiracleMaker to join the Quality team as a Quality Engineer. As a Quality Engineer you will collaborate across the business to drive continuous improvement of the Quality Management System and support operations through the product lifecycle, leading and managing quality events such as Deviations, NCMRs, CAPA, OOS and Complaints, driving thorough investigations and timely completion.

How you will make an impact:

• Champion Quality Assurance and continuous improvement initiatives.

• Collaborate with Manufacturing, QC, R&D, commercial, customer service, technical support, and facilities to continuously improve the Quality Management System and identify risks and mitigations through problem solving.

• Lead and manage Quality Events (Deviations, NCMRs, CAPA, OOS and Complaints) to ensure appropriate investigations are completed promptly.

• Conduct robust quality investigations to assess root cause, corrections, corrective actions, preventive actions, and monitor effectiveness using quality tools, such as 5-Why's, FMEA's, Cause and Effect Diagrams, Process Mapping.

• Assist with planning and execution of equipment installation and qualification activities.

• Review and approval of product batch documentation and disposition of raw materials and finished goods.

• Participate in the internal/external audit program, preparing for and/or conducting internal audits and supporting external quality audits.

• Author, revise, and review quality documents and reports including SOPs, WI, specifications, trend reports, qualification/stability reports, Quality Agreements, and related change control.

• 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 and at least 3 years of relevant experience in a life science industry.

• Deep experience with Quality Management Systems, root cause analysis, and experience reviewing data critically to formulate recommendations for improvement.

• Experience working in ISO environments (ISO 9001 or 13485) and of cGMPs environments (e.g. 21 CFR 210, 211 or 21 CFR 820)

• Experience with biologic products/testing including ELISA and cell based bio-assays and techniques.

• The ability to communicate and work effectively externally and internally across all levels and departments, both verbally and in writing, to convey clear messaging and influence change.

• Ability to identify quality issues/discrepancies and effectively resolve discrepancies within the organization.

• Proficiency with Microsoft Office suite; Outlook, Word, PowerPoint, Excel (for data tracking and analytics) as well as proficiency in a QMS system (we use NetSuite and Master control)

• Working knowledge of electronic documentation systems, data retrieval, and electronic file formats.

• Ambitious and eager to learn with an aptitude for technology. Experience working with digital batch records/notebook systems is a plus.

We welcome all applicants to apply, even if you don't meet every requirement-your unique skills and experiences could be exactly what we're looking for!

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/

Cygnus Technologies, a Maravai LifeSciences company, 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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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 [redacted]. If you believe you have been a victim of fraud, you can report this activity at: www.iC3.gov or www.stopfraud.gov.