Quality Assurance Site 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.
Responsible for managing the internal site auditing program in conformance with Merck Policies, Guidelines, and Procedures. May participate in auditing of external sites and other Merck sites. Lead or assist in managing Health Authority Inspections. Maintain and update regulatory filings and manufacturing authorizations in compliance with cGMPs and Health Agency regulations and all other applicable governing regulations. Develop or assist in developing the site compliance plan and Quality Council Agendas. Provide Quality Manual Systems leadership for Chapter associated with Auditing, and potentially others like Quality Management System Chapter. May serve as a delegate/grant of authority for Director or Associate Director.
Education Minimum Requirement:
- Bachelor's degree in related field
Required Experience and Skills:
- 5 years of experience in pharmaceutical manufacturing or quality control.
- Strong contemporary knowledge of relevant cGMPs and regulations and current industry trends.
- Demonstrated skill and qualification in auditing.
Preferred Experience and Skills:
- Communication and decision making skills: Ability to communicate with all levels of site and MMD organization through all means (written, verbal, presentations, etc.)
- Strong decision making skills.
- Ability to work with and interact with off-site customers and Health Authorities.
- Ability to lead teams.
- Demonstrated ability to manage complex projects.
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: Quality Operations
Job Title:Sr. Spclst, Quality
Primary Location: NA-US-VA-Elkton
Employee Status: Regular
Number of Openings: 1
Shift (if applicable): 1st
Hazardous Materials: Betalactam Antibiotic
Company Trade Name:Merck
Nearest Major Market: Harrisonburg
Nearest Secondary Market: Virginia
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