Your next role as a Miracle Maker 

Maravai LifeSciences is seeking a #MiracleMaker to join our Quality Assurance team as a Senior QA Operations Specialist. In this role, you will lead the maintenance and continuous improvement of the Quality Management System, review and approve product and new product development documentation, and track and report on key quality metrics. You will also ensure compliance with company policies and procedures, as well as applicable domestic and international standards and regulations, including but not limited to ISO 13485.

How you will make an impact: 

• Responsible for reviewing and approving Quality Events (e.g. deviations, non-conformances, OOS, CAPAs, and complaints) to ensure appropriate investigations are thorough and completed in a timely manner.
• Reviews and approves change control of materials, equipment, processes, and procedures including appropriate documentation.
• Maintains the control of documents and records.
• Provides oversight for training program and conduct quality related training. Train or supervise junior team member, as required.
• Conducts quality investigations to assess root cause, corrections, corrective actions, preventive actions, and monitor effectiveness. 
• Leads cross-functional teams in risk identification, mitigation activities, and quality improvement projects.
• Reviews and approves product documentation for disposition of finished goods.
• Compiles, maintains, reports, and presents quality metrics during site Quality Management Reviews to ensure visibility of QMS health, including creating trending graphs for weekly, monthly, and quarterly reports.
• Leads the audit program, including conducting internal audits and hosting external or third-party quality audits (e.g. customers, ISO, etc.).
• Ensures compliance with all in-house or external specifications to standards such as ISO or customer requirements.
• Supports supplier quality by maintaining the approved supplier list, administering supplier surveys, quality agreements, approved supplier list, and performing critical supplier audits as needed.
• Identifies quality issues/ discrepancies and effectively resolves these within the organization.
• 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 5 years relevant experience in a life science industry.
• Requires knowledge of ISO 13485 standards (or ISO 9001).
• Proficient at the use of root cause analysis tools, such as 5-Why's, FMEA's, DMAIC, Cause and Effect Diagrams, Process Mapping, etc.
• 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.
• Proficient in Microsoft Office
• Experience with NetSuite ERP and Qualio is a plus

#LI-Onsite

Your next role as a Miracle Maker 

Maravai LifeSciences is seeking a #MiracleMaker to join our Quality & Regulatory team as a Part-Time Document Control Associate I. As a Part-Time Document Control Associate I, you will be responsible for maintaining the document and record control systems and ensuring they meet Quality Management System (QMS) requirements. This position is responsible for coordinating the issuance, revision, review and approval of SOPs and other documents. 

How you will make an impact: 

• Issue document change order numbers, route and track new and revised documents for approval, file controlled documents and other documentation provided to QA, and ensure that all documentation follows the change control procedures  
• Review documents for completeness, adherence to company guidelines on formatting, and authorization for approvals  
• Monitor status of in-process document changes to ensure timely completion  
• Organize filing systems for electronic and paper based GMP/research documents  
• Support the establishment and improvement of quality systems  
• Facilitate continuous improvements efforts of quality systems  
• Assist in quality audits, including document preparation and record retrieval.  
• Update and maintain quality metrics as needed  
• Support after hours and weekends as needed  
• Perform other functions and duties as required 

 The skills and experience that you will bring: 

• BS Degree in scientific area preferred. 
• Minimum of 1-2 years hands-on experience with document control management, preferably in a life science industry  
• Experience with ISO 9001, ISO 13485,  21CFR820, 21CFR 211, or other regulated industry a plus. 
• Experience with MasterControl or other document management system a plus but not required. 
• Demonstrated ability to work independently and as part of a team  
• Good writing skills, high degree of organization and excellent attention to detail. 
• Good computer skills with working knowledge of MS office suite and Adobe Acrobat. 
• Must be able to support after hours and weekend as needed. 
• Self motivated and able to organize and prioritize multiple tasks.  

#LI-Onsite