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Posted: Monday, March 13, 2017 5:05 AM

Job Description:/h3:
Job Description
:Maintain Receiving Inspection (QARI) and In:Process Inspection (QAPI) programs in accordance with FDA 21 CFR Part 211 and British Retail Consortium requirements.
:Develop, establish and validate routine in:process testing methods and procedures.
:Manages the incoming inspection, in:process inspection, lot code management, production quality and supplier quality programs.
:Manage resources to properly support workload.
:Determines resource requirements, schedules, and procedures to properly monitor ongoing operations.
:Review and approve reports and procedures.
:Facilitate nonconforming product, OOS investigations, and CAPA investigations.
:Maintain in:process and receiving inspection test equipment calibration program.
:Facilitate manufacturing and engineering in establishing and verifying critical process parameters.
:Maintain the change control program together with product life cycle management.
:Provide trend and other management reports to company executives.
:Coordinates and facilitates non:conformance investigations, and notifies management of issues that can impact safety, effectiveness or customer satisfaction in a timely manner.
:Work with Production and Engineering Management to establish and verify critical process parameters for process control of compounding, production and packaging operations.
:Facilitate product life cycle management in evaluating changes to the manufacturing process and product.
:Bachelor Degree in Chemistry or a Life Science with Chemistry Background.
:Lean:six sigma background or certification is preferable.
:Five (5) years experience in quality assurance/quality engineering in the pharmaceutical or medical device industry preferred.
:Five (5) years experience with pharmaceutical or medical device quality management.
:Knowledge of FDA 21 CFR211, 21 CFR820, ISO and related guidance documents.
:Knowledge of Statistical Sampling Plans and Methods including ANSIIASQ Z1.4, ANSI/ASQ Z1 .9 and the One Proportion Test.
:Knowledge of Statistical Process Control Methods including process capability and control charting.
:Project management skills.
:ERP and EQA Programs, Minitab, Microsoft Excel, Word, Power Point, and Adobe AcrobatCompany Description:/h3:
Manufacturer of Personal and Home Care Products


• Location: commack, Long Island

• Post ID: 95531792 newyork 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