Senior Specialist, Quality Assurance - Quality System Improvement Program

  • Company: Merck
  • Location: West Point, Pennsylvania
  • Posted: January 07, 2017
  • Reference ID: QUA005425
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. Today, we are building a new kind of healthcare company - one that is ready to help create a healthier future for all of us.

Our ability to excel depends on the integrity, knowledge, imagination, skill, diversity and teamwork of an individual like you. To this end, we strive to create an environment of mutual respect, encouragement and teamwork. As part of our global team, you'll have the opportunity to collaborate with talented and dedicated colleagues while developing and expanding your career.

This role will report to the West Point Quality System Improvement Lead. Responsible for the Quality System Improvement Program implementation including working on deployment team to assess gaps, implementation strategy, implementation execution and update of site documentation/processes as needed. At times, the incumbent may be a primary SME on changes that require them to train a cross-functional team across the West Point Site. The primary objective of this role is installation of QSIP deliverables on-time, as intended by the Divisional leads, and in a sustainable way to deliver an effective and efficient Quality Management System. This role will also have critical ties to Quality Council and the existing QMS program.

Work is primarily achieved by individual or through project teams. Understands and applies regulatory/compliance requirements relative to their role. Has developed conceptual and practical expertise in own discipline. Applies knowledge of internal/external processes to drive improvements. Solves complex problems; takes a new perspective using existing solutions. Works independently, receives minimal guidance. Acts as a resource for colleagues with less experience within own discipline. May act as a team or project lead and lead work of others as required; promotes teamwork and open discussion of issues, coaches and guides others.

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.

Primary activities include, but are not limited to:
  • Review and approval of IQ/OQ documents
  • Review and approval of System Development Life Cycle documention (SDLC)
  • Provides guidance on automation change controls
  • Review and approval of automation change controls
  • Provides information for regulatory inspections as requested.
  • Maintains expert level of knowledge relating to core internal procedures and applicable regulations (domestic and international). Reviews regulatory citations and other pertinent information.
  • Participates on, or leads teams supporting internal functions and/or evaluating site processes for improvement opportunities.
  • Individual may have the opportunity to support other areas within the MMD West Point Quality Assurance organization, including;
  • Change Control
  • SOP and Batch Record Management
  • Audits and Inspections
  • Deviation Management
  • Annual Product Reviews, Vendor Management
  • Inspection Management, QMS / Quality Council Management
  • Risk Management
  • Market Actions

Education Minimum Requirement:
  • Bachelors degree. Degree in life science, scientific discipline or engineering preferred
  • M.S. degree in life science, scientific discipline or engineering
Required Experience and Skills:
  • For candidates with a Bachelors degree, a minimum of 3 years in GMP Manufacturing environment, Pharmaceutical/Biological Quality, Operational, Technical or Regulatory function supporting manufacturing or testing operations, or related industry experience in a laboratory, manufacturing, science related or regulated setting.
  • For candidates with a Masters degree, a minimum of 2 years in GMP Manufacturing environment, Pharmaceutical/Biological Quality, Operational, Technical or Regulatory function supporting manufacturing or testing operations, or related industry experience in a laboratory, manufacturing, science related or regulated setting.
Preferred Experience and Skills:
  • 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.
  • 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 application of GMPs/GLPs.
  • Proven ability to manage multiple projects simultaneously.
  • Experience in pharmaceutical laboratory operations or related environment.

Our employees are the key to our company's success. We demonstrate our commitment to our employees by offering a competitive and valuable rewards program. Our Company's benefits are designed to support the wide range of goals, needs and lifestyles of our employees, and many of the people that matter the most in their lives. If you need an accommodation for the application process please email us at
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.

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