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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.
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Set Yourself Apart: Profile/Experiences
· Skilled, flexible worker with strong people skills and an extensive background in cGMP manufacturing.
· Knowledge and experience in Current Good Manufacturing Practices (cGMP) regulations, documentation, and compliance.
· Experience leading investigations and technical writing.
· Minimum of 2 years of cGMP post-production experience.
· Direct experience in processes acclimated to post-production.
· Excellent communication and organizational skills with an ability to prioritize effectively and work cross-functionally to deliver results within established timelines.
· Must be detail oriented, able to work in a fast-paced environment
Τι προσφέρεται;
Fagron offers exciting opportunities for personal and professional growth. We provide an open and truly dynamic environment which supports and encourages you to develop your skills and talents.