IPS – Integrated Project Services, Inc.

  • Job Locations US-NC-Wilson | US-NC-Raleigh
    ID
    2018-3672
    Department
    Staffing
    # of Openings Remaining
    1
    Position Type
    W2 Temporary or Fixed Term
    Location : Location
    US-NC-Wilson
  • Position Responsibilities

    IPS is searching for a Deviation Investigator for our client in East Raleigh, NC area. This will be a long term assignment at the client site. The Deviation Investigator is responsible for approval of investigations related to Quality control laboratory Investigations, Environmental Monitoring Investigations and Production related Investigations. 

     

    Additional duties include:

    • Monitor and ensure effectiveness checks of CAPAs are conducted
    • Provide timely updates to management on status of all GMP-related investigations
    • Lead, author, and manage deviations (including OOS, OOT) and robust investigations and re-lated reports to closure within established timelines for the manufacturing department
    • Ensures adequate Root Cause Analysis tools are used for critical and major investigations
    • Work cross-functionally to assess and analyze deviations and investigations to determine im-pact

    Qualifications & Requirements

    • B.S. degree in Technical area, with experience in a manufacturing environment, biopharmaceutical or pharmaceutical industry experience, or an equivalent combination of education and experience
    • 5 or more years of industry experience in Pharmaceutical, Biotech, Medical Device Design, Construction, Commissioning, Validation, or QA. Experience in writing and execution of PFC, FC, IQ, OQ, and PQ forms and protocols for GMP Utilities, Equipment, Systems, and Software.
    • General exposure and experience in a GMP/Validation discipline with a knowledge and understanding of pharmaceutical Design/Build/Commission/Validate processes and how they relate to regulatory requirements and cGMP regulations within the EU and US FDA.
    • Proficiency with Microsoft Office applications.
    • Experience with Cleaning, Process, Computer System, Methods, and other validation activities and processes, beneficial.
    • Experience with Risk-Based Approach to Commissioning and Qualification is beneficial.

     

     

    Company Overview

    About Us

    IPS-Integrated Project Services is a global leader in developing innovative and cost effective solutions for the engineering, construction, commissioning and qualification of complex pharmaceutical and biotech research and manufacturing facilities. With technical expertise spanning R&D to pilot-scale to large-scale production, our team specializes in the technology, trends and regulatory environment to successfully deliver capital projects and improve operations. For over twenty years, we have applied unique LEAN methodologies throughout the project life cycle, continually finding ways to do things better and more efficiently, delivering higher quality and controlling costs. Headquartered in Blue Bell, PA, IPS is a multi-national company with over 800 professionals and offices in California, Indiana, Massachusetts, New Jersey, North Carolina, Pennsylvania, Brazil, China, Singapore, UK and four locations in India. Visit our website at www.ipsdb.com.

     

    Specialties

    Architectural Design, Engineering, Construction, Commissioning, Qualification, LEAN Project Delivery, Strategic Master Planning, Energy Conservation Management, Project Controls, Program/Project Management, Operations/Logistics Strategy and Planning, EPCMV and Staffing Services.

     

    IPS is an equal opportunity, affirmative action employer of protected veterans (M/F/D/V).

     

    Attention Search Firms / Third Party Recruiters:  IPS is not seeking assistance or accepting unsolicited resumes from search firms for employment opportunities with IPS. Regardless of past practice, all resumes submitted by search firms to any employee at IPS via-email, the Internet or directly to hiring managers at IPS in any form without a valid written search agreement in place for a specific position will be deemed the sole property of IPS, and no fee will be paid in the event a candidate is hired by IPS as a result of the referral or through other means.

     

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