QA Operations Specialist I , Discovery

About the position

Maravai LifeSciences is seeking a #MiracleMaker to join our Quality Assurance team as a QA Operations Specialist I, Discovery. As a QA Operations Specialist I you will oversee quality operations for corresponding Discovery business unit (mRNA, Oligo, Small Molecule) ensuring product quality performance is maintained to meet product specifications and customer expectations including compliance with company policies and procedures.

Responsibilities

• Supports customer complaint investigations, identifying root cause(s), trends and escalates concerns of unsatisfactory quality standards for further review and improvement actions.
• Responsible for managing and approving quality events ensuring investigations are adequately conducted to assess root cause, corrections, corrective actions, preventive actions, as required.
• Responsible for developing and maintaining metrics/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).
• Collaborates/approves on DCOs (SOPs, WIs, Forms, Batch Records, etc.).
• Supports Change Controls (MOCs) as required.
• Supports Discovery batch records and associated documentation required for Discovery final product release.
• Supports continuous improvement initiatives through MOC, DCO, or other change management processes.
• Assure compliance with all in-house or external specifications to standards, such as ISO and applicable 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.

Requirements

• Bachelor's Degree in scientific discipline (Chemistry, Biology, Bioengineering, etc.) or equivalent experience.
• Quality professional with 1 to 3 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.
• Experience with quality tools, such as 5-Why's, FMEA's, 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.

Benefits

• 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.