Merck : Quality Control Specialist

Requisition ID: QUA007138

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. The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where Merck has codified its legacy for over a century. Merck’s success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.

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 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.

Qualifications

Education:

• BS/BA or MS in Biology, Biochemistry, Chemistry, Engineering, Microbiology, Virology or other associated field with a minimum of 3 years of relevant laboratory, manufacturing, biotechnology or quality control experience.

Required:

• 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:

• 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.

Your role at Merck is integral to helping the world meet new breakthroughs that affect generations to come, and we’re counting on your skills and inventiveness to help make meaningful contributions to global medical advancement. At Merck, we’re inventing for life.

If you need assistance and/or a reasonable accommodation due to a disability during the application or the recruiting process, please send a request to staffingaadar@merck.com.

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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Job: Qual Assurance & Ops Generic
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Employee Status: Regular
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Company Trade Name: Merck

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