Quality Assurance Specialist Job - United States
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.
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 candidate will join a Quality Assurance team tasked with the quality oversight of animal vaccine manufacturing. The primary duty will be to assist the Quality manager with higher level department responsibilities.
Responsibilities to include:
- Production Batch Record review and disposition.
- Annual Outline Review.
- Validation/Qualification activities
- Evaluation of change proposals in Reliance change management system.
- Lead Routine and annual compliance inspections.
- Assist in investigation and corrective action tracking and closure.
- Primary source for compliance guidance to site colleagues.
Other duties may include
- Maintaining data and Metrics
- Quality improvement projects
- Other assignments as given
* Bachelor Degree, preferably in the physical sciences -OR-, at least five years of work experience in a quality assurance or biologics manufacturing capacity.
- A minimum of 5 years’ experience within USDA, FDA, EMEA or similar regulated facility.
- Working knowledge of good manufacturing practices such as change management, deviation management, GMP documentation, clean room standards and Quality Management systems.
- Excellent written and oral communication skills (including technical writing).
- Possess a high degree of problem solving ability and critical thinking.
- Ability to work independently and manage multiple priority projects
- A minimum of 4 years of GMP experience in a quality role
- Strong knowledge of USDA, FDA or EMEA regulation regarding vaccine manufacture
- Basic understanding of microbiology
- Experience with lean, six sigma or similar
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 firstname.lastname@example.org.
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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.
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Merck is an equal opportunity employer, Minority/Female/Disability/Veteran – proudly embracing diversity in all of its manifestations.
Job: Quality Operations
Job Title:Spclst, Quality
Primary Location: NA-US-MN-Worthington
Employee Status: Regular
Number of Openings: 1
Hazardous Materials: the responsibilities of this position require the employee to enter core sterile manufacturing areas
Company Trade Name:Merck
Nearest Major Market: Worthington
Job Segment: Microbiology, Quality Assurance, Lean Six Sigma, Supply, Technical Writer, Science, Technology, Management, Operations