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 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 complies 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.
Primary Activities include but are not limited to:
The Senior Laboratory Specialist will also train to provide support to Quality Assurance system functions and support Regulatory Agency inspections.
1. Responsible for Quality oversight for the Laboratory shop floor.
2. Actively participates in the Tier process and uses 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, and 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 completes 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. Qualifications: Education Minimum Requirement:
- • Bachelors degree. Degree in life science, scientific discipline or engineering preferred
Required Experience and Skills:
- • M.S. degree in life science, scientific discipline or engineering
Preferred Experience and Skills:
- For candidates with a Bachelors degree, a minimum of 3 years 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 Masters degree, a minimum of 2 years 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.
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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