Manages Problem Analysis and Corrective Action/Preventative Action (CAPA) quality elements for Manufacturing and Packaging.
Is technical resource within the plant for problem solving, Non-Conformances, CAPA system and Complaint System.
Analyzes tracking and trending of Quality Events, Non-Conformances, Investigations and CAPA(s) for Manufacturing and Packaging for the purpose of developing means to improve product quality.
Supports statistical analysis of Quality Events data required for investigations.
Assists manufacturing and packaging in root-cause identification and implementation of effective corrective actions for those circumstances where quality standards are not met.
Develops and writes SOPs for new equipment and procedures as well as enhances existing SOP’s when needed.
Implements Lean and Six Sigma to optimize manufacturing process.
Provides engineering solutions that maximize process efficiency (optimization) and improves quality performance of the assigned processes.
Establishes process flow program for material, personnel, final product, and waste.
Assist in developing technical training tools and perform technical training for manufacturing and packaging staff. Maximizes employee productivity by increasing skills set through training.
Drives continuous improvement by managing projects and recommending techniques to enhance equipment/system/process robustness.
Performs other related duties as assigned.
QUALIFICATIONS:
Bachelor’s Degree, preferably in science, engineering, math, statistics, or equivalent combination of education and experience.
5+ years of manufacturing and packaging experience handling non-conformance, investigations, CAPA(s), and lean programs.
Black Belt or Green Belt certifications desired.
Able to interpret GMPs and other government regulations.
Able to coach and train new personnel on outcomes of Investigations and related CAPAs.
Knowledge of manufacturing/processing techniques, laboratory procedures, Root Cause Analysis and statistical applications is preferred.
Must have strong written and verbal communication skills.
Bilingual in Spanish and English preferred
Must demonstrate initiative, innovation and sound analytical problem-solving skills.
Able to build rapport with coworkers and partner with other departments.