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Quality Operations Supervisor plans and organizes all quality assurance activities related, but not limited to, incoming components, manufacturing floor operations (compounding, filling, utilities and warehouse), new product launches and line trials. Responsible for the day-to-day activities of Quality Operation Specialists and/or Technicians and coordinating communications with external groups. Quality assurance activities include leading deviation handling, root cause analysis and CAPA development, coordinating document reviews to verify effectiveness of procedures and instructions, and providing training and coaching to Quality and Operations on SOP, GMP and root cause analysis.
- Coordinate / support the revision and review of controlled documentation including procedures, investigations, deviations, and reports.
- Oversees performance and development of both their professional and non exempt direct reports
- Participate in routine GMP, internal and corporate audits
- Support and align to appropriate data integrity guidelines.
- Responsible (where applicable) for the Quality function during line trials for new products and components
- Monitor budget for the team
- Provide training and coaching to Quality and Operations, on topics such as SOP, GMP and root cause analysis
- Lead the coordination of Investigations of customer and consumer complaints
- Coordinate communications with external groups regarding quality issues (i.e. Operations, Quality Labs, Tech Services, Assembly, Packaging, SRP, Distribution and Vendors)
- Manage / coordinate the daily tasks and administration of the Quality Operations team for their shift or area
- Support and guide decisions around disposition out-of-spec materials
- Certify CAPA completion and effectiveness
- Escalate critical issues as required
- Coordinate the documentation reviews in the quality team and provide feedback to the plant (production, importation and compounding) as applicable for compliance with existing procedures and instructions, and verify the effectiveness of procedures and instructions versus EL requirements and needs
- Issues Resolution/Continuous Improvement (60%)
- Provide expertise to support RFT goals and development of improvement initiatives with Quality Engineers, CI and ME
- Monitor progress against improvement initiatives identified by Quality Engineers, CI and ME
- Lead the effort to review deviations, determine root cause, and develop CAPAs in collaboration Quality, Operations staff and suppliers to address product quality issues and GMP related activities
- Experience in Fast Paced Consumer Goods manufacturing environment a plus (Cosmetic, Food, or Pharma)
- Experience in executing, summarizing and managing process audits in the manufacturing areas
- Proficiency in Microsoft Office Suite, Electronic QMS, and SAP systems is preferred
- Knowledge and ability to execute statistical sampling, AQL/ANSI interpretation, and read/interpret specifications, drawings and compounding/assembly instructions
- Good team management skills
- Ability to review SOP’s, GMP reports, batch records and investigations
- Knowledge of OTC Manufacturing a plus
- Strong oral and written communication skills and ability to appropriately communicate information to cross functional stakeholders and suppliers
- 4 year degree (OTC releases) or equivalent experience( non OTC suoervision)
- Experience in interpreting and assessing operational compliance against Good Manufacturing Practice Regulations (FDA, KFDA, HC, ISO22716)
- Ability to identify and drive process improvement opportunities by partnering with cross functional stakeholders
- Ability to utilize standard tools and equipment (such as scale, fill weight, cap torque, viscometer, pH meter, pull force, seal burst, and other relevant equipment)
- Experience in executing and coaching teams in root cause problem solving and associated Corrective and Preventive Actions (CAPA)
Company: The Estée Lauder Companies Inc.
Vacancy Type: Part Time
Job Location: Philadelphia, PA, US
Application Deadline: N/A