Specialist Deviation Management 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 specialist within the Laboratory Operations under the direction from the Associate Director of Laboratory Operations-chemistry and virology (LOCV) Deviation Management, will be investigating and authoring atypical investigation reports for laboratory testing. The incumbent assures operation in accordance with MMD and Company safety policies and procedures, cGMP regulations, and within the departmental budget. Responsibilities include leading investigations for atypical events within the following laboratory areas: chemistry, virology, biochemistry and microbiology. The incumbent is expected to be able to work in a team environment to support cross-functional investigations. Additionally the incumbent is expected to present investigative findings to regulatory agencies as part of GMP inspections. Supports the development of action plans to resolve atypical events and serves as a role model to others within the organization to ensure compliance with cGMPs and regulatory requirements to support the quality, safety, efficacy, and potency of Merck products.
Education Minimum Requirement:
- BS/BA or MS in Biology, Biochemistry, Chemistry, Engineering, Microbiology, Virology or other associated field with a minimum of 5 years of relevant laboratory, manufacturing, biotechnology or quality control experience.
Required Experience and Skills:
- Demonstrated interpersonal skills including flexibility, collaboration and inclusion skills, and ability to work in a team environment. Demonstrated technical expertise in laboratory testing, technical writing, and experience with deviation management procedures.
Preferred Experience and Skills:
- 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.
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.
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Merck is an equal opportunity employer, Minority/Female/Disability/Veteran – proudly embracing diversity in all of its manifestations.
Job: Quality Lab Related
Job Title:Spclst, Quality Control
Primary Location: NA-US-PA-West Point
Employee Status: Regular
Number of Openings: 1
Company Trade Name:Merck
Nearest Major Market: Philadelphia
Job Segment: Biochemistry, Microbiology, Biotech, Manager, Engineer, Science, Management, Engineering