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Quality Specialist

Merck


Location:
West Point, PA
Date:
07/20/2017
2017-07-202017-08-19
Job Code:
QUA006090
Merck
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Job Details

Job Title: Quality Specialist  - QUA006090

Description

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.

 

Responsible for the Quality Assurance aspects of Change Control, including providing guidance on change level and type, running Advisory Council meetings and providing guidance on change control documentation structure and task assignments. In addition, responsible for carrying out divisional requirements as necessary.

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.

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:

•Leads the Change Control Advisory Council meetings.

•Provides guidance on change control classification and task requirements.

•Provides information for regulatory inspections as requested.

•Ensures adherence to divisional reporting requirements and assessments of the change control system.

•Maintains expert level of knowledge relating to core internal procedures and applicable regulations (domestic and international). Reviews regulatory citations and other pertinent information.

 

Individual may have the opportunity to support other areas within the MMD West Point Quality

 

Assurance organization, including:

*SOP and Batch Record Management

* 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:  

  • B.S or M.S. in Scientific or Engineering field or equivalent experience in the pharmaceutical industry.

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 application of GMPs.

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:

 

            

            



Job Qual Assurance & Ops Generic

Primary Location NA-US-PA-West Point

Other Locations 

Employee Status Regular

Number Of Openings 1

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