Descripción del Trabajo
Represent the quality function of technical support, in conjunction with other internal support groups, regarding issues affecting manufacturing on global customer accounts. Serve as liaison between Jabil and suppliers or customers on global quality related issues.
ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. Other duties may be assigned.
· Develop and maintain QA plans and timeliness of global new product introductions utilizing Advanced Product Quality Planning and Process Optimization specific to the customer.
· Provide support for all quoting activities by participation in initial process design, development, and implementation phases.
· Evaluate and provide input to inspection processes via inspection aids and instruction guidelines.
· Support all global training programs specific to their customer by development and implementation of specialized training sessions for all applicable functions.
· Develop appropriate systems for document storage, access and review pertaining to global customer accounts.
· Review all supplies, internal, and customer discrepancies, coordinate and track the effectiveness of corrective/proactive action efforts.
· Conduct periodic review and maintenance of all documentation files; develop appropriate systems for document storage and access.
· Review all supplier or customer discrepancies. Coordinate and track the corrective/preventative action effort.
· Participate in the vendor survey activities as applicable. Drive proactive participation with suppliers and (when possible) aid in their process improvement efforts.
· Interface with all departments as applied to the Policies and Procedures.
· Provide insight and assistance of implementing and maintaining Process Improvement and Optimization concentrating on proactive methodologies.
· Assist in driving the standardization of manufacturing processes of global customer accounts.
· Interface and provide technical support on quality issues with the customer as needed.
· Adhere to all safety and health rules and regulations associated with this position and as directed by supervisor.
· Comply and follow all procedures within the company security policy.
• Support Additive Manufacturing (AM) workcell operation and provide quality oversight of manufacturing operations and the release of components, sub-assemblies and final finished goods products to support the Supply Chain and Distribution of FGs
• Maintains databases and systems used for tracking various GMP manufacturing associated support activities.
• Compile pertinent QA metrics for Workcell Management review
• Assists with the generation and/or revision of GMP documentation such as standard operating procedures
• Supports the issuance of Non-Conformances Records and reconciliation of GMP documentation
• Support/Host regulatory (FDA, EMA) inspections, as well as internal audits
• Works closely with Manufacturing, Facilities, Supply Chain and Quality Control staff to resolve quality issues with regards to the facilities and product manufactured
• Electronic system usage with tools such as SAP, Trackwise, ETQ, etc.
• Reviews documented information from other functional area, reports abnormalities
• Assists by assembling KPIs as requested for various functional areas
• Create and deliver Quality System/Compliance training as required
• Provides task-oriented training to QA Techs employees
• Initiates and/or reviews and approves minor deviations; completes tasks related to CAPA and Change Control action items
• Application of corporate and industry regulations and standards to job function
• Identifies and coordinates new process improvements in their functional area
• Prioritizes day-to-day support for their functional area and long-term projects or investigations
• Represents QA, as needed, during meetings relevant to their functional area, communicates and tracks all follow-up items through to completion
• Serves as subject matter expert for area core functions and provides guidance to colleagues
• Acts as team lead and can delegate work to others
• Represents the organization on cross-functional and external teams
• Other duties as assigned
• Bachelor’s degree required in Industrial Engineering, Mechanical Engineering
• 5 years GMP experience or other regulated industry
• 5 years providing support to cGMP medical devices/pharmaceutical production or other regulated industry preferred
• Familiarity with Good Manufacturing Practices (GMPs), 21 CFR 210/211, ISO 13485
• Exposure to Lean Operational Excellence highly desirable.
Experience within pharmaceutical or medical device industry performing direct hands-on work in a Quality Assurance/Quality Control/Mfg Operations function with a strong familiarity of general GMP documentation.
Additional duties may involve:
Being responsible for providing supervision for QA technicians (RMI, In-Process, and Release) in the AM workcell area. Responsibilities include providing QA oversight of manufacturing including observing critical processes and performing visual inspection, executed GMP documentation review and supporting other QA functions as needed.