Specialist, Quality Control

Merck & Co., Inc. Durham , NC 27701

Posted 2 months ago

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 interdependent global manufacturing network committed to deliver a compliant, reliable supply to customers and patients on time, every time, across the globe.

The main function of the Specialist, Quality Control 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, as necessary to support vaccine manufacturing.

Primary Responsibilities

General

  • Understands and performs release testing in support of product, including sterility testing, detection of residual moisture, average cell dry weight testing.

  • Understands and performs microbiological testing; evaluation of environmental microbiological samples, Limulus Amebocyte Lysate (LAL) testing, and bioburden testing

  • Understands and performs environmental sampling to include active air and surface sampling and water sampling

  • Evaluates data, conducts trouble shooting, process improvements, report writing, involvement in interdepartmental committees and projects.

  • Completes assignments in alignment with department objectives

Functional Expertise

Specific to In-Process and Final Product Release testing and Environmental Monitoring, the Associate Specialist will be responsible for the following:

  • Performs In-Process and Release testing

  • Performs Routine and Per Process Environmental Monitoring of processes on a routine basis

  • Authoring Investigational, CAPA, and Batch Quality Notifications (QNs)

  • Authoring SOPs

Problem Solving

  • Identifies and resolves technical and operational problems in collaboration with colleagues and under guidance from department head

Impact

  • Influence: Communicates information, asks questions and checks for understanding

  • Accountability: Accountable for own performance

  • Decision Making: Makes decisions guided by policies and procedures on the shop floor | Consults on an as-needed basis with next-level manager on more complex decisions and/or issues that impact other units with inter-related processes

Education Minimum Requirements

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

Required Experience and Skills

  • Minimum one (1) year experience in a quality reviewer role

  • Understanding and application of GLPs and cGMPs

  • Experience with aseptic technique

  • Experience working in a team environment

Preferred Experience and Skills

  • Strong verbal and written communication skills

  • Prior experience in the performance of environmental and water systems monitoring

Working Relationships

  • Reports to Quality Control Manager

  • Interacts with employees within own department and from other departments

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

Who we are

Merck & Co., Inc., Kenilworth, New Jersey, USA is known as "Merck" in the United States, Canada & Puerto Rico. We are known as "MSD" in Europe, Middle East, Africa, Latin America & Asia Pacific. We are a global biopharmaceutical leader with a diverse portfolio of prescription medicines, oncology, vaccines and animal health products.

We are driven by our purpose to develop and deliver innovative products that save and improve lives. With 69,000 employees operating in more than 140 countries, we offer state of the art laboratories, plants and offices that are designed to Inspire our employees as we learn, develop and grow in our careers. We are proud of our 125 years of service to humanity and continue to be one of the world's biggest investors in Research & Development.

What we look for

In a world of rapid innovation, we seek brave Inventors who want to make an Impact in all aspects of our business, enabling breakthroughs that will affect generations to come. We encourage you to bring your disruptive thinking, collaborative spirit and diverse perspective to our organization. Together we will continue Inventing For Life, Impacting Lives while Inspiring Your Career Growth.

INVENT.

IMPACT.

INSPIRE.

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.

US and Puerto Rico Residents Only:

If you need an accommodation for the application process please email us at staffingaadar@msd.com

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

EEOC Poster

EEOC GINA Supplement

OFCCP EEO Supplement

OFCCP Pay Transparency Rule

We are an equal opportunity employer, Minority/Female/Disability/Veteran - proudly embracing diversity in all of its manifestations.

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:

Travel Requirements:

10%

Flexible Work Arrangements:

Not Specified

Shift:

1st

  • Day

Valid Driving License:

Yes

Hazardous Material(s):

BSL2 Organisms

Number of Openings:

2

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Specialist, Quality Control

Merck & Co., Inc.