IPS – Integrated Project Services, Inc.

  • Job Locations US-PA-Marietta
    ID
    2018-3456
    Department
    CQV - Validation
    # of Openings Remaining
    1
    Position Type
    W2 Temporary or Fixed Term
    Location : Location
    US-PA-Marietta
  • Position Responsibilities

    IPS is hiring! We are looking for a talented Technical Writer to join our industry leading CQV- Commissioning, QualificationValidation team at our client site located in Marietta, PA.

     

    This position will provide compliance assurance through the review of records to include batch documentation, training records, calibration records, standard operating procedures, regulatory policies, testing and manufacturing specifications, validation documents, and other technical documents; leading investigations, initiating deviations and determining corrective action.

     

    Job Duties and Responsibilities

     

    • Lead cross functional team to investigate deviations. Initiate deviations using a qualified system such as SAP and prepare clear, concise reports from outcome of
    • Perform root cause analysis, FMEA’s and collaborates with the Industrial Excellence team to use other tools to address manufacturing concerns. Determine robust corrective actions and / or
    • Ensure timely completion of manufacturing discrepancy commitments. This includes writing, revising, or coordinating the efforts for change controls, standard operating procedures, batch documentation and training
    • Track, trend, and evaluate manufacturing discrepancies and work to determine root causes. This includes tracking and trending using a visual
    • Prepare, maintain and track change controls and CAPAs for the manufacturing
    • Interact and coordinate with appropriate personnel including manufacturing, QA/QC, regulatory, technical services,
    • Communicate immediately with QA and Operations management for all manufacturing discrepancies that impact product quality 
    • Develop internal audit schedule (including area to be audited) on a yearly basis and communicates the schedule to the site Quality organization. Interact with external regulatory authorities as needed during routine and non-routine
    • Represent the manufacturing department at the site change control and Quality Systems meetings. Perform all job responsibilities in compliance with applicable EHS and GMP regulations, guidelines, policies, standard operating & safety procedures, and industry practice and Industrial Excellence initiatives.
    • Special projects as assigned.

    Qualifications & Requirements

    • Minimum of 1-3 years pharmaceutical experience investigating manufacturing deviations either in a QA or manufacturing role; preferably in Biologics Secondary Manufacturing.
    • B.S or B.A in a technical discipline, preferably Microbiology, Biology/Virology, Biochemistry, Chemistry or Pharmacy. Degree in other discipline if sufficient technical depth has been achieved from professional experience.

    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 1,000 professionals worldwide and offices in California, Indiana, Kansas, Massachusetts, New Jersey, North Carolina, Pennsylvania, Brazil, Canada, China, Singapore, Switzerland, UK and four locations in India. Visit our website at www.ipsdb.com.

     

    Specialties

     

    Process Architecture, Process 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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