Temporary Quality Assurance Associate

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 anticipated salary range for this position is $26.50 - $30.25 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.