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Temporary Quality Assurance Associate
4 months ago
**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 Quality Assurance Associate. As a Temporary Quality Assurance Associate you will support Quality Systems function, including review and approval of deviations, NCMRs, CAPAs, OOSs and complaints. You will also ensure compliance with company policies and procedures and applicable domestic and international standards and regulations.
**How you will make an impact**:
- Responsible for initiating and reviewing Quality Events (e.g. Deviations, NCMRs, CAPA and OOSs) to ensure appropriate investigations are completed in a timely manner.
- Conduct 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.
- Review Change Control requests to ensure the appropriate documentation is in place for changes in materials, equipment, processes, procedures, 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**:
- Minimum, Bachelor's Degree in scientific discipline (Chemistry, Biology, Bioengineering, etc.).
- Quality professional with a minimum of 2-4 years relevant experience in a life science industry.
- Must be able to work on second shift (3PM to 12AM). Will work on first shift (8AM to 5PM) for initial training. Support weekend as needed.
- Requires knowledge of ISO 9001 standards (or ISO 13485) and cGMPs regulations (e.g. ICH Q7 Practice Guidance for Active Pharmaceutical Ingredients, or 21 CFR 210, 211 or 21 CFR 820),
- 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 benefits of being a #Mirac**le**Maker**:
- 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.
- Click here to view Maravai LifeSciences Privacy Notice_
**HIRING SCAM ALERT**
- Maravai LifeSciences will never provide excess money to an applicant and ask the applicant to write a check for repayment.
