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Website Estée Lauder
Job Description:
Quality Operations Specialist is responsible for quality assurance activities related, but not limited to, incoming raw materials & components, manufacturing floor operations (compounding, filling, utilities and warehouse), and suppliers. Quality assurance activities include leading deviation handling, root cause analysis and CAPA development, conducting 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.
Job Responsibilities:
- Monitor progress against improvement initiatives identified by Quality Engineers, CI and ME
- Initiate, revise and review controlled documentation including procedures, investigations, deviations, and reports.
- Escalate critical issues to Quality/Operations leadership as required
- Investigate critical customer and consumer complaints
- Disposition out-of-spec materials, as directed
- Perform final (for importation yearly) review of executed batch and filling records and disposition product
- Participate in routine GMP audits in the plant
- Certify CAPA completion and effectiveness
- Identify and review deviations, determine root cause, and develop CAPAs in collaboration with Quality, Operations staff and suppliers to address product quality issues and GMP related activities
Job Requirements:
- Ability to identify and drive process improvement opportunities by partnering with cross functional stakeholders
- 3 years experience
- Ability to interpret and assess operational compliance against Good Manufacturing Practice Regulations (FDA, KFDA, HC, ISO22716)
- Knowledge and ability to execute statistical sampling, AQL/ANSI interpretation, and read/interpret specifications, drawings and compounding/assembly instructions
- Ability to execute and coach teams in root cause problem solving and associated Corrective and Preventive Actions (CAPA)
- Ability to execute, summarize and manage process audits in the manufacturing areas
- Experience in Fast Paced Consumer Goods manufacturing environment a plus (Cosmetic, Food, or Pharma)
- Effective oral and written communication skills and ability to appropriately communicate information to cross functional stakeholders and suppliers
- 4 year degree or equivalent experience
- 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)
Job Details:
Company: Estée Lauder
Vacancy Type: Full Time
Job Location: Bristol, PA
Application Deadline: N/A
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