Quality Control Specialist:
Merck

QUA006835-en_US
Merck
DeSoto Kansas
Pharmaceutical
Description
Requisition ID: QUA006835

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. 

 

The Quality Control Specialist position is available at the Merck Animal Health facility in De Soto, Kansas, located near Kansas City metropolitan area.  The DeSoto facility is expanding operations to manufacturing vaccines and biologics for large and companion animals.  Leveraging an experienced and innovative team environment, the key technologies at the site are biologics production using fermentation and cell culture platforms, filling and packaging.


This position requires a thorough understanding of the principles underlying the testing procedures used in the areas of assignment. In addition, a thorough understanding of the material being evaluated (virus, bacteria, cell line) is also required. The ability to use experience and/or education to optimize testing activities is expected. Perform in QC lead role as assigned for performance of annual Outline of Production/Special Outline reviews and participation in annual review meetings – 55%


Responsibiitlites consist of but not limited to:

  • Independently plan and perform quality control procedures. 
  • Review records for compliance. 
  • Troubleshooting established testing methods and evaluating new testing methods. 
  • Take lead role in QC testing investigations to determine root causes and develop effective corrective and preventive actions. 
  • Coordinate QC representation in working group meetings to resolve production and testing issues. Maintain and evaluate the sequential analysis of the testing standards used in the area of assignment.
  • Prepare and qualify test reagents/supplies.
  • Perform in lead role for tracking QC reagent inventories for all tests performed by DeSoto QC and lead and/or coordinate reagent replenishment projects with applicable Biological Technical Support (BTS), Analytical Technical Support (ATS), Research and Development (R+D), and QC personnel. 
  • Create and revise Standard Operating Procedures (SOPs)/test methods/test worksheets for testing performed in the area(s) of assignment. 
  • Perform in QC lead role for protocol and report preparation. 
  • Perform in QC lead role for applicable assay transfers from R&D or other sites; work closely with the assay transfer coordinator to assure timely and compliant transfers. 
  • Ensure Adequate Tier 2 and Tier 4 Representation in absence of QC manager and provide leadership in QC Tier 1 meetings as assigned. – 20%
  • Enter test results in the appropriate tracking system. 
  • Cross-check wet records with information in the tracking system and evaluate test dispositions (satisfactory, unsatisfactory, inconclusive, no test). 
  • Responsible for closing QC inspection results and performing batch usage decisions in SAP for batches tested by QC. 
  • Report to QC Manager all unusual, non-routine occurrences when performing tasks. – 20%
  • Participate in project teams and/or complete/design special projects. Special Projects / Stretch Assignments and other lead roles as assigned – 5%



Qualifications


Education :

  • Minimum Bachelors degree in a related field 
Required :
  • A minimum of five years related experience including a thorough knowledge of procedures, paperwork, and specific laboratory testing experience. 
  • Ability to work independently and follow oral and written instructions. 
  • Excellent oral and written communication skills and ability to interface with all levels of the organization. 
  • Excellent computer skills (i.e. Word, Excel, Power Point, Microsoft Office, SAP, etc.). 
  • Ability to work on a team with people from both inside Quality Control as well as other departments such as Research and Development and Manufacturing. 
  • Excellent mathematics and writing skills. 
  • Ability to independently prepare written reports for submission to United States Department of Agriculture (USDA) and other agencies. 
  • Individual must be highly organized and possess good planning skills to handle multiple projects.
Preferred :
  • Proficiency with advanced laboratory techniques and procedures relating to USDA 9 Code of Federal Regulations (CFR) testing of veterinary biologicals preferred. 
  • Cell culture and viral titration experience. Effective leadership skills.

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 

AHMAN2017



Job: Quality Lab Related
Other Locations:
Employee Status: Regular
Travel: Yes, 5 % of the Time
Number of Openings:
Shift (if applicable):
Hazardous Materials:
Company Trade Name: Merck
Basic Qualifications
Requirement