Quality Management Consultant

Responsibilities:

• Responsible as Quality focal point for MQSA by providing quality leadership for site.
• Lead monthly quality review meetings for MQSA to ensure health of quality at site.
• Ensure compliance towards GLP regulations for site. Mitigate any compliance gaps if identified.
• Partner with MQSA business partners to ensure delivery of projects related to quality for site.
• Execute and support quality management system (QMS) activities (i.e., change control, non-conformance, CAPA, observations, documentation)
• Support quality review/approval of EQ documentation (i.e., equipment validation; service requests; governance documentation)
• Responsible for the change control component of Trackwise application related to the EQ QMS
• Support quality activities associated with quality events and technical service requests at the Raritan Site
• Provide metrics and reports required for Quality Systems Management Review
• Support records management by:
• Partnering with Corporate RIM Operations on existing RIM program
• Archive inactive documents on-site within the secured Records Management Library. Preparing documents for archiving on offsite locations designed for protective storage
• Periodic Review of Equipment Logbooks and Laboratory notebooks
• Responsible for organizing and/or delivering trainings to service and support teams associated with good documentation practices or other quality related topics
• Strong knowledge of good Documentation and Data Integrity Practices in accordance with cGMP
• Provide innovative solutions to improve quality in the Research, Development and GMP areas at a lab facility
• Working knowledge of Labvantage ELN and LIMS system is preferred.
• Working knowledge of 21 GLP Part 58 compliance is preferred