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Posted: Monday, September 4, 2017 10:10 AM

Job Description Position Overview: Supervises the quality assurance program for the pharmaceutical department of the plant, in compliance with relevant federal regulations, customer expectations, and Amcor standards. Supervises audits of the pharmaceutical department. Oversees validations of new product, qualifications on plant equipment, inspection, laboratory testing, statistical process control and corrective action with a mindset of continuous improvement. Essential Responsibilities and Duties: Analyzes quality control test results and provides feedback and interpretation to production management or staff for the purpose of improving quality and operating systems which meet customer requirements and best practice audits Supervises inspection of incoming materials, work-in-process materials, rework materials and finished goods to assure the required level of quality through visual inspection, statistical sampling and laboratory testing of materials; ascertains reasons for nonconforming materials Establishes, monitors and controls Hold For Inspection (HFI) procedures to ensure nonconforming materials do not enter the production process and are properly identified and segregated. Leads corrective actions for quality related problems at the plant and/or customer location and for start-up of new products; assists in troubleshooting technical problems Utilizes quality techniques to reduce process variations or refine process parameters Establishes, monitors, and maintains statistical process control (SPC) programs; advises and instructs local managers in utilization of SPC data; maintains corporate database(s) that house customer specifications and established guidelines for achieving those requirements related to product safety, quality, legality, process and specification (Windchill and RealSPC or corporate approved equivalent software applications) Leads and promotes problem solving teams to perform root cause analysis and failure investigations Implements and tracks corrective and preventative actions to ensure items are successfully closed out on a timely basis Alerts management of potential quality problems to assure that defective raw materials are not used or that defective products are not shipped to the customer; ensures that potential defective product is contained and performs necessary sorts Assists in development of standard operating procedures, work instructions and form control documents Assists with customer complaint investigations and vendor incident notifications Supervises audits including internal (ie, IA, Good Manufacturing Practices), external and customer. Maintains pharmaceutical safety and compliance documentation in accordance with regulatory, customer, and third party audit requirements. Visits customers and vendors as needed Manages team of direct reports and is responsible for employee selection, development, mentoring, and performance management. Responsible for overall talent management and employee engagement; cultivates an environment of safety, high performance, and ethical and legal compliance; addresses employee relations issues Qualifications: Education: Bachelor's Degree In Quality, Engineering or a related technical field 5 years of experience in a quality assurance role Professional accreditation in quality (ASQ, CQE) highly preferred; required within 3 years of service Strong statistical analysis expertise and experience using SPC Strong verbal and written communications skills Experience with internal, customer, and third party Quality System Auditing (FDA QSIT preferred) Experience with ISO 13485 quality systems or food safety certifications AIB International, Inc. Experience in Medical Device/Pharmaceutical/ or Quality Assurance of aseptic manufacturing preferred Experience working in FDA regulated industry preferred (21 CFR 820, Title 21 Part 210-211) Experience with automated quality gauging and measurement systems (eg AVID) Experience with customer relations written responses, verbal communications and face to face interactions Proficiency in the following software: Word, Power Point, Excel, MS Project, Visio Competencies: Amcor Leadership Framework Competencies Core Competencies: Customer Focus Learning on the Fly Interpersonal Savvy Drive for Results 3-5 Applicable ALF Competencies: Influencing Others Process Management Managing & Measuring Work Functional/Technical Skills Relationships: Plant leadership Corporate staff and leadership Regional leadership Direct reports External Customers Some material suppliers for the pharmaceutical department IND123 ZP123 Company Description Amcor is the world's largest publicly traded packaging company; a market and innovation leader adding value to the world


• Location: Fort Worth

• Post ID: 65258852 fortworth is an interactive computer service that enables access by multiple users and should not be treated as the publisher or speaker of any information provided by another information content provider. © 2017