Sr. Specialist Laboratory 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 globe.
The Senior Laboratory Specialist within the Quality Assurance Center of Excellence, with guidance from the Associate Director of Quality Assurance, ensures that all necessary laboratory documentation (CRs / ACRs, IOQs, PQs, etc) is reviewed, approved, valid and compliant with all site procedures, MMD Policies and Guidelines and Regulatory requirements. This person is responsible for working closely with the various groups within Laboratory Operations in a team environment to enable the timely testing and subsequent release of product to the marketplace.
The Senior Laboratory Specialist is responsible for providing Quality direction and oversight to WP Laboratory Operations in the management of those areas assigned, such as Internal Auditing, Training, Change Control, Inspection Management, Documentation, Deviation Management and Risk Management in order to maintain compliance with Regulatory requirements. The individual is an Advocate for the development, execution and deployment of WP Site and MMD priorities. He or she will assist in driving quality improvement activities and will work to ensure alignment across Laboratory Operations. The Senior Laboratory Specialist will also train to provide support to Quality Assurance system functions and support Regulatory Agency inspections.
Job Responsibilities include but are not limited to:
1. Responsible for Quality oversight for the Laboratory shop floor.
2. Actively participates in the Tier process and use this forum to escalate concerns and best practices.
3. Performs Quality review and approval of investigative events in Laboratory Operations.
a. Determines the effects on test result validity, for laboratory investigative events, to ensure final reportable values are
representative of the product’s quality.
b. Provide input on recommended CAPAs, as appropriate.
4. Performs review and approval for CAPAs, QCTS commitments, change requests, investigative protocols and final reports.
5. Performs review and approval of IQ/OQ/PQ documents for assigned laboratories of responsibility.
6. Completes training to become a qualified auditor and performs monthly internal audits of laboratory areas.
7. Writes, reviews and approves Standard Operating Procedures, Controlled Job Aides, Control Procedures, Quality Standards, etc.
8. Provides coaching and guidance to new personnel and to Quality Specialists who are training new personnel.
9. Provides support to Regulatory Agency inspections as needed.
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.
Education Minimum Requirement:
- A minimum of a Bachelor’s degree is required.
- A degree in life science, scientific discipline or engineering is preferred.
- A Master's degree in life science, scientific discipline or engineering is preferred.
Required Experience and Skills:
- For candidates with a Bachelor’s degree, a minimum of 3 years of experience in GMP Manufacturing environment, Pharmaceutical / Biological Quality, Operational, Technical or Regulatory function supporting manufacturing or testing operations, or related industry experience in a laboratory, manufacturing, science related or regulated setting.
- For candidates with a Master’s degree, a minimum of 2 years of experience in GMP Manufacturing environment, Pharmaceutical / Biological Quality, Operational, Technical or Regulatory function supporting manufacturing or testing operations, or related industry experience in a laboratory, manufacturing, science related or regulated setting.
- Progressive and demonstrated Quality decision making responsibility
- Demonstrated interpersonal skills including flexibility, collaboration and inclusion skills and ability to work in a team environment.
- Demonstrated self-starter with capability to develop innovative solutions to challenges.
- 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.
- Experience in pharmaceutical laboratory operations or related environment.
If you need an accommodation for the application process please email us at firstname.lastname@example.org.
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Visa sponsorship is not available for this position.
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Job: Quality Operations
Employee Status: Regular
Number of Openings:
Shift (if applicable):
Company Trade Name: Merck