Senior Specialist, Quality Assurance Job
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
Positions are for the WP Quality
Inspection/Audit team. The positions will support the inspection and internal
audit process. Responsibilities may vary depending on business critical needs.
Primary responsibilities will include:
audits of the WP site
agencies through declarations
related to the inspection process
Work is primarily achieved by individual or through project
teams. Understands and applies regulatory/compliance requirements. Applies
knowledge of internal/external processes to drive improvements. Solves complex
problems; takes a new perspective using existing solutions. Works
independently, receives minimal guidance.
Interprets customer needs, assesses requirements and identifies solutions to
non-standard requests. Explains difficult issues and works to build alignment
around a complex situation. Makes decisions within guidelines and policies
which impact a range of standard and non-standard customer, operational, project
or support activities.
Individual may have the opportunity to support other areas within the MMD West
Point Quality Assurance organization, including:
- SOP and Batch Record Management
- Change Control
- Audits and Inspections
- Automation Compliance
- Deviation Management
- Annual Product Reviews, Vendor Management
- Inspection Management, QMS / Quality Council Management
- Risk Management
- Market Actions
Education Minimum Requirement:
- A minimum of a Bachelor’s
degree is required. A degree focused in Science or Engineering is preferred.
- A Master’s degree in
Scientific or Engineering field is a plus.
Required Experience and Skills:
Regulatory, or related experience with progressive and demonstrated
Quality decision making responsibility
flexibility, collaboration and inclusion skills, and ability to work in a
develop innovative solutions to challenges.
skills, and ability to apply key concepts.
Preferred Experience and Skills:
regulatory or third party auditors.
Monitoring and/or Automation compliance
expertise/experience is a plus.
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
If you need an accommodation for the
application process please email us at firstname.lastname@example.org.
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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
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rights under Equal Employment Opportunity, visit:
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Job: Qual Assurance & Ops Generic
Employee Status: Regular
Number of Openings:
Shift (if applicable):
Company Trade Name: Merck