Specialist, Quality Control

  • Company: Merck
  • Posted: February 01, 2017
  • Reference ID: QUA005563
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.

Independently plan and perform quality control procedures. Review records for compliance. 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%

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), 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 all unusual, non-routine occurrences when performing tasks to QC Manager. - 20%

Participate in project teams and/or complete/design special projects. Special Projects / Stretch Assignments and other lead roles as assigned - 5%

Education Minimum Requirement:
  • Minimum Bachelors degree in a related field
Required Experience and Skills:
  • 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 Experience and Skills:
  • Proficiency with advanced laboratory techniques and procedures relating to USDA 9 Code of Federal Regulations (CFR) testing of veterinary biologicals preferred.
  • Effective leadership skills.

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 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:

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