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.

Key Responsibilities

• 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.
• Aid in 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.
• 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.

Basic Qualifications

• 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.
• Prioritize 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.

What's on Offer?

• 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

• We work in an open, dynamic environment where your ideas and talents can shine.

Equal Opportunity Employer

Fagron 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.