Quality Assurance Specialist
5 days ago
About the Opportunity:
Omni Inclusive's Manufacturing Sciences and Technology team seeks a skilled Quality Assurance Specialist to join our team as a Deviation Investigator. This individual contributor role is responsible for investigating No Impact, Minor, Major, and Critical deviations to determine root cause, corrective actions, and ensuring written reports contain technical merit and completeness according to regulatory expectations.
As a key player in the Jump MSAT team, you will champion quality priority principles and compliance within the organization. You will operate cross-functionally, collecting necessary data and information associated with manufacturing and laboratory investigations, and determining the associated corrective action to prevent deviation reoccurrence.
Key Requirements:
- Expertise in GMP compliance and FDA/EMA regulations
- Demonstrate excellence in written and verbal communication
- Demonstrated ability to work cross-functionally and develop strong business partner relationships
- Innovative, proactive, and resourceful; committed to quality and continuous improvement
- Ability to anticipate and mitigate challenges
Responsibilities:
- Actively manage deviations to achieve RFT (right first time) and on-time phase completion, including deviation closure by the original due date
- Participate in investigation planning, data collection, and analysis to determine root cause and corrective actions
- Collaborate with cross-functional teams to develop and implement corrective actions to prevent deviation reoccurrence
- Develop and maintain expertise in multiple RCA tools and apply them as needed
- Ensure smooth transition of CAPA to owning departments and ensure timely implementation to facilitate on-time deviation closure
Education and Experience:
- Minimum of Bachelor's degree in relevant Science or Engineering discipline and/or equivalent combination of work experience
- 5+ years of relevant cGMP experience
- Experience in FDA/EMA regulation in the biotechnology and/or cellular therapy field is preferred
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