Senior Specialist, Quality Control Job - United States
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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.
This role will report to the West Point Laboratory Operations, Quality Control, Associate Director. Responsible for Quality Systems support of Laboratory Operations, Chemistry and Virology. Primary activities include, but are not limited to: Provides information for regulatory inspections as requested and facilitate all aspects of regulatory inspections and internal audits for Lab Ops QC such as pre-requests, scheduling. Maintains a broad-based knowledge of GMPs, Merck Manufacturing Policies, Guidelines and Procedure, and regulatory guidance. Reviews regulatory citations and other pertinent information. Participates on, or leads teams supporting internal functions and/or evaluating site processes for improvement opportunities.
Education Minimum Requirement:
- Bachelors degree. Degree in life science, scientific discipline or engineering preferred
Required Experience and Skills:
- For candidates with a Bachelors degree, a minimum of 3 years in GMP Manufacturing environment, Pharmaceutical/Biological Quality, Operational, Technical or Regulatory function supporting manufacturing or testing operations, or related industry experience in a laboratory, manufacturing, science related or regulated setting.
- For candidates with a Masters degree, a minimum of 2 years in GMP Manufacturing environment, Pharmaceutical/Biological Quality, Operational, Technical or Regulatory function supporting manufacturing or testing operations, or related industry experience in a laboratory, manufacturing, science related or regulated setting
Preferred Experience and Skills
- 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.
- 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/GLPs.
- Proven ability to manage multiple projects simultaneously.
- Experience in pharmaceutical laboratory operations or related environment
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 email@example.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 GINA Supplement
Merck is an equal opportunity employer, Minority/Female/Disability/Veteran – proudly embracing diversity in all of its manifestations.
Job: Quality Lab Related
Job Title:Sr. Spclst, Quality Control
Primary Location: NA-US-PA-West Point
Employee Status: Regular
Number of Openings: 1
Shift (if applicable): 1st
Company Trade Name:Merck
Nearest Major Market: Philadelphia
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