Specialist, Quality Control

Job Description

The Specialist in the Vaccine Biological Critical Reagents (BCR) group will be responsible for supporting the vaccines BCR programs. This position will perform hands-on laboratory work for biological critical reagents, such as reference standards, positive controls, and other critical materials. Under guidance from the Manager and/or Senior Specialist, the incumbent will help support the entire lifecycle of BCRs, from generation and testing to inventory and shipping. All work will be conducted to the highest quality and conform to GMP and regulatory expectations.

The Specialist in the Vaccine BCR group will be responsible for helping support Critical Reagent programs in a fast-paced environment within the vaccines franchise. The performance of the critical reagents used in release and stability testing within the Quality Control Laboratories is important for release of vaccines products. This position requires experience in general cell biology, molecular biology, virology and/or biochemistry techniques. Under the guidance of a Manager and/or Senior Specialist, the Specialist is responsible for helping to manage the complete lifecycle of critical reagents, including reference standards, positive controls, anti-sera and other critical materials.

The BCR lifecycle includes acquisition, certification and qualification testing, implementation, sample and inventory management, and ongoing monitoring and replacement of the material as required per established procedures. Additionally, the individual will demonstrate understanding in the implementation, execution and management of BCRs, and ensure work is conducted to the highest quality, and conforms to current Good Manufacturing Practices and regulatory expectations. The Specialist will help provide bioanalytical support to Global Manufacturing Division sites as needed and respond to regulatory questions, co-author analytical license sections, and support regulatory inspections as necessary.

The Specialist understands how the job responsibilities contribute to the departmental goals; manages assigned tasks within given timelines and demonstrates the ability to distribute accurate information but may need guidance in crafting messages for target audiences; and independently solve problems that arise within job responsibilities and expectations.

Education Requirement

B.S. or M.S. in Biology, Virology, Molecular Biology, Biochemistry, Chemistry, or related biological science

Experience and Skills

Required
  • Bachelor degree with three to give years laboratory experience | Master degree with one to three years laboratory experience
  • Demonstrated leadership and teamwork skills
  • Work Independently | Lead Project Teams | Plan, Prioritize, and Effectively Manage Tasks Independently
  • Meet deadlines and product quality deliverables
  • Work effectively in a collaborative team environment
  • Laboratory experience, knowledge of laboratory operations and bioanalytical instrumentation
  • GMP


Preferred
  • Previous technical and/or analytical troubleshooting experience in biologics development, and/or quality laboratory
  • Proficiency in biochemistry, and/or cell biology techniques
  • Statistical analysis and/or familiarity with JMP
  • Technical | Analytical Data Comprehension
  • Judgment, organization and project management abilities


Our Manufacturing & Supply Division is dedicated to being the most trusted supplier of bio-pharmaceuticals worldwide. Our facilities, along with our external contractors, suppliers, and partners, create a reliable global manufacturing network that's devoted to delivering a high quality, reliable supply to customers and patients on time, every time.

Who we are ...

We are known as Merck & Co., Inc., Kenilworth, New Jersey, USA in the United States and Canada and MSD everywhere else. For more than a century, we have been inventing for life, bringing forward medicines and vaccines for many of the world's most challenging diseases. Today, our company continues to be at the forefront of research to deliver innovative health solutions and advance the prevention and treatment of diseases that threaten people and animals around the world.

What we look for ...

Imagine getting up in the morning for a job as important as helping to save and improve lives around the world. Here, you have that opportunity. You can put your empathy, creativity, digital mastery, or scientific genius to work in collaboration with a diverse group of colleagues who pursue and bring hope to countless people who are battling some of the most challenging diseases of our time. Our team is constantly evolving, so if you are among the intellectually curious, join us—and start making your impact today.

NOTICE FOR INTERNAL APPLICANTS

In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions.

If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor.

Current Employees apply HERE

Current Contingent Workers apply HERE

US and Puerto Rico Residents Only:

Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process.

For more information about personal rights under Equal Employment Opportunity, visit:

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We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively. We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace.

Search Firm Representatives Please Read Carefully
Merck & Co., Inc., Kenilworth, NJ, USA, also known as Merck Sharp & Dohme Corp., Kenilworth, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

Employee Status:
Regular

Relocation:
No relocation

VISA Sponsorship:
No

Travel Requirements:
No Travel Required

Flexible Work Arrangements:
Flex Time, Remote Work

Shift:
1st - Day

Valid Driving License:
Yes

Hazardous Material(s):

Number of Openings:
1

Requisition ID:R130830