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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.
Qualifications
: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

Source: https://www.tiptopjob.com/jobs/64730651_job.asp?source=backpage


• Location: commack, Long Island

• Post ID: 95531792 newyork
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