Senior Specialist, Quality Assurance Job

Employer
Merck
Location
West Point, PA, US
Posted
October 12 2017
Discipline
Other
Organization Type
Pharma
Requisition ID: QUA006293

Merck & Co., Inc. Kenilworth, N.J.,
U.S.A. known as Merck in the United States and Canada, is a global health care
leader with a diversified portfolio of prescription medicines, vaccines and
animal health products. The difference between potential and achievement lies
in the spark that fuels innovation and inventiveness; this is the space where
Merck has codified its legacy for over a century. Merck’s success is
backed by ethical integrity, forward momentum, and an inspiring mission to
achieve new milestones in global healthcare.





Merck Manufacturing Division, MMD, is a team of dedicated, energetic
individuals who are committed to being the most trusted supplier of
pharmaceuticals and health products worldwide. Our facilities, along with our
external contractors, suppliers, and partners, comprise an interdependent
global manufacturing network that’s committed to delivering a compliant,
reliable supply to customers and patients on time, every time, across the
globe. 



 

Positions are for the WP Quality
Inspection/Audit team. The positions will support the inspection and internal
audit process. Responsibilities may vary depending on business critical needs.



Primary responsibilities will include:



  • Onsite inspection activities:  
  • Support on site regulatory and third party
    audits of the WP site
  • Scheduling of inspection activities
  • Pre-inspection contract with agencies and
    third parties
  • Logistic coordination for inspections
  • In room and back room support during the
    inspection
  • Documentation of the inspection activities
  • Communication of inspection outcomes
  • Post inspection support activities:
  • Tracking findings and actions in trackwise
    based system
  • Supporting the response process
  • Review of support documentation
  • General Support
  • Support the communication of information to
    agencies through declarations
  • Provide training and guidance to the WP site
    related to the inspection process
  • Audit responsibilities
  • Site Internal Audits
  • Lead or support site level audits at the WP
    site
  • Participate as guest auditor at non-WP site
    audits
  • Maintain current on cGMP practices
  • Identify and remediate risks through the site
    audit process
  • Support the site shop floor audit program


  • Work is primarily achieved by individual or through project
    teams. Understands and applies regulatory/compliance requirements. Applies
    knowledge of internal/external processes to drive improvements. Solves complex
    problems; takes a new perspective using existing solutions. Works
    independently, receives minimal guidance. 



    Interprets customer needs, assesses requirements and identifies solutions to
    non-standard requests. Explains difficult issues and works to build alignment
    around a complex situation. Makes decisions within guidelines and policies
    which impact a range of standard and non-standard customer, operational, project
    or support activities. 



    Individual may have the opportunity to support other areas within the MMD West
    Point Quality Assurance organization, including: 



    • SOP and Batch Record Management 
    • Change Control
    • Audits and Inspections 
    • Automation Compliance 
    • Deviation Management 
    • Annual Product Reviews, Vendor Management 
    • Inspection Management, QMS / Quality Council Management 
    • Risk Management 
    • Market Actions 




    Qualifications

    Education Minimum Requirement:

    • A minimum of a Bachelor’s
      degree is required. A degree focused in Science or Engineering is preferred.
    • A Master’s degree in
      Scientific or Engineering field is a plus.


    Required Experience and Skills: 

  • Minimum 5 years in Pharmaceutical Quality,
    Regulatory, or related experience with progressive and demonstrated
    Quality decision making responsibility 
  • Demonstrated interpersonal skills including
    flexibility, collaboration and inclusion skills, and ability to work in a
    team environment. 
  • Demonstrated self-starter with capability to
    develop innovative solutions to challenges. 
  • Deliver results across diverse areas at
    Site 
  • Proven analytical aptitude, critical thinking
    skills, and ability to apply key concepts. 
  • Speaks with courage and candor. 
  • Strong written and verbal communication
    skills. 
  • In-depth working knowledge and experience with application of
    GMPs.

  • Preferred Experience and Skills:



  • Past experience interacting directly with
    regulatory or third party auditors.
  • Experience conducting internal/external audits.
  • Validation, Lab Operations, Aseptic, Environmental
    Monitoring and/or Automation compliance 
    expertise/experience is a plus.
  • Audit related certifications.


  • Your role at Merck is integral to
    helping the world meet new breakthroughs that affect generations to come, and
    we’re counting on your skills and inventiveness to help make meaningful
    contributions to global medical advancement. At Merck, we’re inventing for
    life.



    If you need an accommodation for the
    application process please email us at staffingaadar@merck.com.



      

    Search Firm Representatives Please Read
    Carefully: 



    Merck & Co., Inc. is not accepting
    unsolicited assistance from search firms for this employment opportunity. 
    Please, no phone calls or emails.  All resumes submitted by search firms
    to any employee at Merck via email, the Internet or in any form and/or method
    without a valid written search agreement in place for this position will be deemed
    the sole property of Merck.  No fee will be paid in the event the
    candidate is hired by Merck as a result of the referral or through other means.



     

    Visa sponsorship is not available for
    this position.



     

    For more information about personal
    rights under Equal Employment Opportunity, visit:



     

                EEOC Poster

                EEOC GINA Supplement 



    Job: Qual Assurance & Ops Generic
    Other Locations:
    Employee Status: Regular
    Travel: No
    Number of Openings:
    Shift (if applicable):
    Hazardous Materials:
    Company Trade Name: Merck