Your next role as a Miracle Maker

Maravai LifeSciences is seeking a #MiracleMaker to join our Quality Assuranceteam 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.