Specialist, Quality Assurance (Quality Systems Improvement Program) Job

Employer
Merck
Location
West Point, PA, US
Posted
October 12 2017
Discipline
Other
Organization Type
Pharma
Requisition ID: QUA006325

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. 



 

Reporting to a West Point Quality System Improvement Project
(QSIP) Associate Director on the team, this role has responsibility for
supporting the QSIP workstream deployment through managing logistics, assisting
with gap assessments, reviewing documents, and tracking CAPAs. The successful
candidate, as an integral member of the site QSIP team, will assist site
workstream leads to build and/or improve the sitewide Quality Management
programs in accordance with initiatives driven by the Divisional QSIP. Work is
primarily achieved through project teams and partnership with site sub-system
owners (SSOs) and site subject matter experts. This role will require working
cross functionally with Operations, Technology, and Quality. There is an
opportunity for one individual to primarily support Quality Risk Management
initiatives at the West Point site where responsibilities would include
management of the site quality risk register and coordination of risk review
activities.



Primary activities may include, but are not limited to:



  • Work in an empowered culture with a moderate level of
    guidance and direction.
  • Assist Communications lead with creating and deployment of
    site and global level communications.
  • Assisting Work stream leads in deployment of site-based
    training to personnel impacted by Quality System enhancement initiatives
  • Assist SMEs in collating comments, updating, reviewing, and
    circulating procedures for approval.
  • Apply team effectiveness skills, listening, and integrating
    diverse perspectives from across the workgroup; contributes and adds value to
    the achievement of goals.
  • Solve a range of straightforward problems.
  • Participate on teams supporting internal functions and/or
    evaluating site processes for improvement opportunities.
  • Provide information for regulatory inspections as needed. 
  • Potential opportunity to support other areas within MMD West Point Quality Assurance. 
  • One individual will have the opportunity primarily support
    Quality Risk Management (QRM) where activities include:
    • Maintain site quality risk register.
    • Report site QRM metrics and status to the site and appropriate
      global groups.
    • Coordinate residual risk reviews. 
    • Coordinate schedule-based risk reviews.
    • Aggregate QRM Risks based on common hazards or causes and
      support transfer of aggregated quality risk information to Integrated Risk
      Management (IRM) Site Risk Register






Qualifications

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. 



 

Education Minimum Requirement: 

  • A minimum of a Bachelor’s degree is
    required.
  • A degree focused in Science,
    Engineering, or Business is preferred.


Required Experience and Skills: 

  • A minimum of 3 years in GMP
    Manufacturing environment, Pharmaceutical/Biological Quality, Operational, or
    Technical function supporting manufacturing or testing operations, or related
    industry experience in a laboratory, manufacturing, science related or
    regulated setting.
  • In-depth working knowledge and application
    of GMPs and/or GLPs.
  • Strong and effective communication
    skills (both written and oral).


 

Preferred Experience and Skills:

  • Quality Risk Management experience is a
    plus.
  • Hands on experience with CAPAs and SOP
    revision is a plus.
  • Demonstrated interpersonal skills including
    flexibility, collaboration and inclusion skills, and ability to work in a team
    environment.
  • Experience with process improvements.
  • Proven analytical aptitude, critical
    thinking skills, and ability to apply key concepts.
  • Speaks with courage and candor.
  • Proven ability to manage multiple
    projects simultaneously.
  • Strong customer service focus.


 

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