Specialist, Quality Control

Date: May 16, 2019

Location: Wilson, NC, US

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Requisition ID: QUA008930

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. 


Position Description: 

  • Completes a variety of testing to support release and stability requirements for a variety of products. Supports all areas of the laboratory, cross-training and providing testing support in various work cells as required. Provides training to other teammates and serves as subject matter experts.
  • Works with other Merck sites to ensure delivery schedules of samples to be tested are met.
  • Maintains compliance by following corporate policies/guidelines and local procedures. Identifies improvements to procedures and revises/trains others on the changes completed.
  • Supports and leads continuous improvement projects with minimal assistance and works to ensure sustainability of implemented changes identified through lean six sigma tools/activities.
  • Identifies and implements changes focused on improving compliance performance in the laboratory.
  • Leads Tier I Activities and coordinates daily activities to ensure on-time, compliant testing is completed within their work cell. Actively participates in Tier II and, as needed, Tier III.
  • Demonstrates in-depth understanding of product performance and testing methodology. Able to train others on both.
  • Promotes an environment conducive with the 12 Inclusive Behaviors, actively promotes an inclusive culture and leads by example.
  • Ensures work is completed right first time. Leads root cause analysis and corrective action identification for deviation occurrences and properly documents investigations. Identifies proactive measures to ensure right first time achievement.
  • Leads remediation of monthly walk thru audits observations and works to ensure compliant operation of the laboratory to ensure successful outcomes of audits.
  • Works cross functionally to ensure proper prioritization/effective utilization of laboratory equipment.
  • Tests and interprets results for raw materials, active pharmaceutical ingredients, water, microbial limit testing, finished pharmaceutical products, and stability samples.
  • Interprets compendial and internal monographs, NDAs, CFR and Merck Quality Standards.
  • Provides technical and analytical support for cleaning validations, laboratory support requests, equipment validations, method transfers, and API Stability Packaging Description (ASPD).
  • Ensures laboratory compliance by adhering to cGMP, CFR, EU and other agency regulations.
  • Identifies improvement opportunities and both independently and as a facilitator of change, implements improvements. Learns a variety of tools to drive continuous improvement (lean six sigma, human error prevention, etc.).
  • Demonstrates leadership by maintaining a safe workplace and identifying actions to prevent safety incidents in the laboratory.
  • Maintains 5S organization throughout the laboratory and leads 5S activities to ensure compliance
  • Provides guidance and coaching to new analysts within and outside his/her cell.



Qualifications

Education Minimum Requirement:

  • B.S. degree (preferably in Chemistry Science), M.S. preferred
Required Experience and Skills: 
  • Minimum 6 years of pharmaceutical industry experience
  • Previous experience managing APIs ( Active Pharmaceutical Ingredients) material testing
  • Previous experience using glove box for sample weighing
  • Strong knowledge of Liquid Chromatography (LC)
  • Knowledge of regulatory/compliance requirements, including GMP, NDA, and related regulations

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 assistance and/or a reasonable accommodation due to a disability during the application or the recruiting process, please send a request to 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 

          OFCCP EEO Supplement

 
Merck is an equal opportunity employer, Minority/Female/Disability/Veteran – proudly embracing diversity in all of it’s manifestations.


Job: Quality Lab Related
Other Locations:
Employee Status: Regular
Travel: Yes, 5 % of the Time
Number of Openings: 1
Shift (if applicable): 1st
Hazardous Materials: Some chemical reagents (strong acids / bases)
Company Trade Name: Merck


Nearest Major Market: Raleigh
Nearest Secondary Market: Rocky Mount

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