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Merck
Durham, North Carolina, United States
3 days ago

Description

Job Description

Our Quality Assurance group ensures every single material inside our products is manufactured, processed, tested, packaged, stored and distributed aligned with our incredibly high standards of quality and meets all regulatory requirements. Partnering across our internal manufacturing facilities, external contract manufacturers and suppliers we create an interlinking global manufacturing network pledged to deliver a compliant, reliable supply to customers and patients on time, every time, across the globe.

We are seeking a Growth and Improvement minded Vaccine Quality Control Specialist that can help drive our Strategic Operating Priorities.
  • Invent| Pursue the Most Promising Internal and External Science to Address Significant Unmet Medical Needs
  • Execute| Prioritize Resources Behind Our Key Growth Drivers (Oncology, Vaccines, Select Specialty Areas, Animal Health) While Optimizing Our Base Business)
  • Adapt| Develop Our People, Culture and Business Model to Evolve with a Dynamic Landscape
  • Diverse Talent| We are committed to providing an inclusive and welcoming environment with supporting leadership behaviors because having a high-performing, engaged workforce is critical to our ability to deliver innovative solutions to patients and customers around the world
  • Values and Standards| Our Steadfast Commitment to Our Values and Standards will Continue to Guide Us as We Take on New Challenges and Will Always be Fundamental to Our Success - They are a Competitive Advantage for Us


Strategic Summary

The main function of the Vaccine Quality Control Specialist is to assist in the assurance of the quality of vaccine products through the performance and review of microbiological, chemical and analytical sampling and assays as well as interacting with Production, Quality Assurance, Validation and Facilities, and external resources.

Key Responsibilities

General
  • Work independently and as a Team member with Integrity | Precision | Accomplishment | Motivational Ambition | Respect | Inclusion
  • Conducts release testing in support of product, including sterility testing, detection of residual moisture, average cell dry weight testing
  • Completes microbiological testing; evaluation of environmental microbiological samples, Limulus Amebocyte Lysate (LAL) testing, and bio-burden testing
  • Conducts environmental sampling to include active air and surface sampling and water sampling
  • Evaluates data, conducts trouble shooting, process improvements, report writing
  • Completes assignments in alignment with department objectives.
  • Schedule can varies from Sunday through Thursday or Tuesday through Saturday. Standard 8 am to 5 pm.


Functional Expertise

Specific to In-Process and Final Product Release Testing and Environmental Monitoring
  • Conducts In-Process and Release testing
  • Drives and participates in routine and per Process Environmental Monitoring of processes on a routine basis
  • Authoring SOPs


Problem Solving
  • Identifies and resolves technical and operational problems in partnership with colleagues and under guidance from department head


Education
  • Bachelor of Science degree in Biology, Chemistry, Biochemistry, or related field


Required
  • Two years experience in a GMP regulated industry
  • Comprehension and application of GLPs and cGMPs
  • Experience with aseptic technique


Preferred
  • Principled verbal and written communication skills
  • Experience in the performance of environmental and water systems monitoring


Our Manufacturing & Supply Division is dedicated to being the most trusted supplier of biopharmaceuticals 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., Rahway, 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.

New hires in office-based roles in the US & Puerto Rico will be required, subject to applicable law, to demonstrate that they have been fully vaccinated for COVID-19 or qualify for a medical or religious exemption to this vaccination requirement that can be accommodated without an undue burden to the operation. However, subject to applicable law, employees working in roles that the Company determines require routine collaboration with external stakeholders, such as employees in health services, customer facing commercial, or research based roles, will be required to be fully vaccinated as a condition of employment.

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:

EEOC Poster

EEOC GINA Supplement

OFCCP EEO Supplement

Pay Transparency Nondiscrimination

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.

Residents of Colorado:

Click here to request this role's pay range.

Search Firm Representatives Please Read Carefully
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, 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:
10%

Flexible Work Arrangements:
On-Site

Shift:
1st - Day

Valid Driving License:
No

Hazardous Material(s):
Cleaning supplies, BSL2

Number of Openings:
2

Requisition ID:R194250

Job Information

  • Job ID: 64986992
  • Location:
    Durham, North Carolina, United States
  • Position Title: Vaccine Quality Control Specialist
  • Company Name For Job: Merck
  • Job Function: Industrial Pharmacist
  • Job Type: Full-Time
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