Quality Assurance Auditor 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.
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.
The candidate will join a Quality Assurance team tasked with the quality oversight of animal vaccine manufacturing. The primary duty will be to serve as quality specialist for Integrated Production Team (IPT). Responsibilities to the IPT include:
- Production Batch Record review and disposition.
- Review and disposition of quality events, deviations and product risk assessments.
- 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 IPT.
- Other duties may include
- Annual Outline Review
- Seed Management
- Maintaining data and Metrics
- Quality improvement projects
- Other assignments as given
- Associates Degree in science, engineering or equivalent area of study....OR, at least two years of work experience in a quality assurance/control environment.
- Working knowledge of good manufacturing practices and quality management systems.
Basic understanding of microbiology
- 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
- Previous Quality Assurance experience within USDA, FDA or, similar regulated facility.
- Knowledge of USDA regulations regarding vaccine manufacture
- Certified Quality Auditor
- Experience in aseptic manufacturing
- Experience with lean, six sigma or similar
- Degree in Biology, Biotechnology or Chemistry
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.
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: Qual Assurance & Ops Generic
Job Title:Assoc. Spclst, Quality Assurance
Primary Location: NA-US-NE-Elkhorn
Employee Status: Regular
Number of Openings: 1
Hazardous Materials: Yes
Company Trade Name:Merck
Nearest Major Market: Omaha
Nearest Secondary Market: Council Bluffs
Job Segment: Audit, Microbiology, Biotech, Engineer, Lean Six Sigma, Science, Finance, Engineering, Management