Senior Specialist, Quality Assurance -GMP:
Merck

REG003513-en_US
Merck
Rahway New Jersey
Pharmaceutical
Description
Requisition ID: REG003513

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.
 
The Senior Specialist is responsible for ensuring a current, compliant and efficient GMP quality management system for Merck Animal Health. This person may also be required to provide backup QA support for the GLP quality management system and continuously pursue system improvements to optimize QA processes in accordance with current laws and guidelines.
  • Provide QA support for the GMP systems to ensure the maintenance of compliance of the GMP Quality Program. Provide backup QA support for GLP activities.
  • Perform critical review of batch records, raw data, and laboratory/manufacturing deviations in reference to internal and external standards. Provide support for planning, coordination, performance and documentation of both internal and external audits in line with appropriate requirements.
  • Provide support for planning, scheduling and performing routine GMP compliance training.
  • Maintain an efficient document management system for controlled documents. Maintain documentation of QA tasks in compliance with associated requirements and internal SOPs.
  • Provide support for global QA initiatives and keep current on QA trends in the Animal Health industry.
  • Communicate across R&D QA team and foster a productive and efficient team environment. 
Qualifications

Education:
  • Bachelor of Science degree (minimum) in science, engineering, or other relevant field (advanced degree preferred).

Required:

  • A minimum of three (3) years of relevant experience in a pharmaceutical GMP QA role.
  • A high level of professionalism, demonstrated oral and written communication skills, demonstrated understanding of related fields, and leadership skills (problem solver, ability to deal with multiple priorities, strong interpersonal skills, sound judgement and attentive to details)

Preferred:

  •  An understanding of the FDA Good Laboratory Practices.

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 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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Job: Regulatory Affairs Generic
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