Senior Specialist Quality 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 Quality Sr. Specialist will be responsible for supporting Critical Reagent programs in a fast-paced environment within the Vaccine franchises. The support is critical to testing within the Quality Control Laboratories. This position requires experience in general cell biology and either virology or biochemistry techniques. Under the guidance of an Associate Director, the Quality Sr.
Specialist is responsible for independently managing the complete lifecycle of Critical Reagents such as; reference materials, positive controls, anti-sera and other critical materials. Release and stability testing of vaccine and biological products use these reagents. Reagent lifecycle includes; acquisition, certification and qualification testing, implementation and ongoing monitoring and replacement of the material as needed.
Additionally, the individual will work independently and demonstrate leadership in the implementation, execution and management of reagents, as well as perform appropriate second person peer document reviews, support activities and project work associated with their position, and ensure work is conducted to the highest quality, compliant and conforms to current Good Manufacturing Practices and regulatory expectations.
Provide bio analytical support to Global MMD sites as needed and respond to regulatory questions, author of analytical license sections and support regulatory inspections.
Education Minimum Requirement:
- B.S., M.S. in Biology, Molecular Biology, Biochemistry, or related biological science
Required Experience and Skills:
- Bachelor’s with a minimum 5 years’ of laboratory experience. Master’s with a minimum of 3 years of laboratory experience.
- Demonstrated leadership and teamwork skills and ability to work independently.
- Strong technical knowledge and high level of technical performance.
- Laboratory experience, knowledge of laboratory operations and bio analytical instrumentation.
Preferred Experience and Skills:
- Previous technical and/or analytical troubleshooting experience in vaccine or biologics development, and/or quality site experience.
- Proficiency in classical biochemistry assays or molecular biology techniques or cell based assays.
- Experience in one or more of the following: Rate Nephelometry, ELISA, HPLC, PCR, potency and TSCT assays.
- GMP experience.
- Statistical analysis experience with familiarity with JMP or Minitab.
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.
For more information about personal rights under Equal Employment Opportunity, visit:
EEOC GINA Supplement
Merck is an equal opportunity employer, Minority/Female/Disability/Veteran – proudly embracing diversity in all of its manifestations.
Job: Quality Lab Related
Job Title:Sr. Spclst, Quality Control
Primary Location: NA-US-PA-West Point
Employee Status: Regular
Number of Openings: 1
Shift (if applicable): 1st
Hazardous Materials: Biosafety Level 2
Company Trade Name:Merck
Nearest Major Market: Philadelphia
Job Segment: Biochemistry, Law, Laboratory, Statistics, Scientific, Science, Legal, Data, Engineering