Post Production Quality Investigator VI

About the Job

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

• Initiate, author and complete deviations and investigations related to Post-Production Visual Inspection events. 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 visual inspection investigations and CAPAs through use of Root Cause Analysis tools and risk assessments.
• Investigate via camera review, production errors, inspector audits, etc.
• Provide quick, quality-based decisions while serving as the immediate escalation path for all staff associated with visual inspection.
• Support post-production continuous improvement initiatives.
• Establish key performance indicators in alignment with department goals, maintain and report applicable area or organizational metrics.
• Track and trend visual inspector metrics involving inspection times, components, rejection rates, identified defects, etc.
• Collaborate with visual inspection management to author, review or revise applicable SOPs, batch records, and other operational related documents.
• Assist with technical training for post-production visual inspection operations associated with common errors or concerns.
• 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 visual inspection.
• Assist assigned functional area leads in driving problems to resolution.

• 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 with visual inspection processes, training and documentation.
• Prefer 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.

Fagron offers its associates competitive salaries and a wide range of benefits including a 401(k) plan with a company matching contribution; medical, vision and dental; health savings account (HSA); holiday/paid time off.

At Fagron, you’ll find plenty of chances to grow — both personally and professionally. We work in an open, dynamic environment where your ideas and talents can shine.

We’re proud to be an equal opportunity employer. Diversity makes us stronger, and we’re committed to creating an inclusive workplace where everyone feels welcome.

Fagron US is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race; creed; color; religion; national origin; sex; age; disability; sexual orientation; gender identity or expression; genetic predisposition or carrier status; veteran, marital, or citizenship status; or any other status protected by law.