Post Production Quality Investigator

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Job Summary

The primary purpose of the Post-Production Quality Investigator role is to lead investigations, CAPAs and Change Controls related to our post-production manufacturing.

Responsibilities:

· Initiate, author and complete deviations and investigations related to Post-Production SOP excursions. Collaborate with post-production manufacturing and Quality to investigate errors and complete deviations and Corrective and Preventive Actions (CAPAs). Ensure timely signoff of deviations and CAPAs to enable product release.

· Facilitate and lead meetings to investigate and coordinate the resolution of post-production manufacturing investigations and CAPAs through use of Root Cause Analysis tools and risk assessments.

· Provide quick, quality-based decisions while serving as the immediate escalation path for all operational staff during post-production activities.

· Support post-production continuous improvement initiatives.

· Establish key performance indicators in alignment with department goals, maintain and report applicable area or organizational metrics.

· Collaborate with Senior Post-Production leads to author, review or revise applicable SOPs, batch records, and other operational related documents.

· Conduct technical training for post-production manufacturing operations.

· Conduct review of post-production operations to ensure compliance to procedures.

· Other tasks and duties as assigned by Area Management.

· Investigate, document findings and influence assessment for deviations.

· Actively participate on teams with SMEs within post-production.

· Assist assigned functional area leads in driving problems to resolution.