External Site Quality Lead External Quality Assurance
Location: Rahway, New Jersey
Posted: January 28, 2017
Reference ID: EXT000233
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.
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 .
The individual selected will have an unique combination of analytical and chemical processing scientific skills in order to effectively assist all activities necessary for support of a Quality Operations program to manufacture, test, package, store, and distribute sterile pharmaceutical products, API intermediates, API, non-sterile pharmaceutical products, biologics, drug delivery devices and consumer care products. Able to function independently.
1. Assist in the oversight of an EP involving releasing of the products to the market with the assurance that the goods were produced in conformance to all applicable policies and procedures of Merck and compliance with all governing regulations.
2. Assist with the review of batch documentation and deviation investigations.
3. Incorporate risk management principles including special focus on data integrity.
4. Participate in audit readiness, regulatory inspection support and monitoring, effective complaint management, change control oversight, metric review, and review of annual product reviews.
5. Assist in the reviews of audit outcomes pertaining to the EP and ensures appropriate and timely corrective actions are identified and implemented.
6. Coordinates significant investigations including Fact Findings and product recalls as needed.
7. Build and maintain strong relationship with external parties, operations, technology and procurement.
BS Biology, Microbiology, Pharmacy, Chemistry, Chemical Engineering (or equivalent) preferred.
Minimum of 8 years' experience in the pharmaceutical industry with a thorough knowledge of Quality Systems, Quality Assurance and Quality Control including solid knowledge of global GMP and regulatory requirements.
Experience in Chemical Processing.
C ompetent in analyzing complex product, production and testing issues and have demonstrated scientific problem solving capabilities.
Possess strong compliance mindset, demonstrated interpersonal skills.
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.
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