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Merck & Co. Inc.

Senior Specialist, Quality (R131907)

Pharmaceuticals

All

Yearly

No

Elkhorn, Nebraska, United States

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 dedicated to deliver a compliant, reliable supply to customers and patients on time, every time, across the globe.

The Senior Specialist, Quality Systems & Compliance will work, independently and in a Team setting, in the BTS (Bio-Analytical Technical Support) 3R (Reduce, Refine and Replace) Team. Work will include direct involvement in the development, trouble shooting and validation of new in vitro assays to replace animal model-based (in-vivo) assays. This role is recognized as a technical expert, readily conducts complex experimentation, and comprehends the under-lying scientific principles behind applicable scientific methods and projects. For this position a strict focus will be on delivering value for customers by comprehending and meeting their needs and will also require active listening skills to gain differing perspectives and strategic thinking and project management skills.

Position Responsibilities

  • Development, troubleshooting and validation of novel in vitro assay

  • Routine partnership with BTS 3R Team Leads, Regulatory Affairs (RA), Quality Control (QC), Bio-Analytical Technical Support (B-ATS), Research & Development (R&D), Bioprocess Tech Support Production, colleagues as appropriate

  • Periodically reviews and preparation of in vitro test data for statistical analysis

  • Chairs or participates in cross-functional project teams (including R&D, Regulatory Affairs, Quality, Ops, statisticians, etc.)

  • Manages reference standards and supporting bio-material inventories used in assay development

  • Supports local, regional, and global program initiatives

  • Conducts subject related literature searches

  • Initiates, conducts, and reports experiments using new ideas and/or approaches described in the literature

  • Interacts closely with fellow scientists within their own and other departments. If required, initiates contacts with external collaboration partners in consultation with the direct manager

  • Involved in authoring and review of development and validation reports

  • Prepares training plans and supervises training of new employees

  • Fulfills general tasks within the organization related to GMP, Environmental, Health & safety (EHS), and Information and Technology (IT)

  • Publishes and presents technical papers to internal and external audiences, (co-) author of scientific publications

Education

  • At least a Bachelor's degree in science, engineering, or related areas of study.

Required

  • At least 5 years of relevant work experience in the pharmaceutical/biotech industry

  • Good Manufacturing Practices (GMP) | Good Laboratory Practices (GLP) settings

  • Prior bench level laboratory experience

  • Expanded knowledge in at least one biological area; experience in other biological areas

  • Strong computer skills (Excel, PowerPoint, Word etc.) with effective communication and writing skills

Preferred

  • Development of bioassays

  • Biological assays (ELISA, Luminex, HPLC, Virus Titration, Bacterial Plate Count, PCR, and Toxin-Neutralization Testing)

  • Managing critical reagent inventories

  • Preparing and interpreting basis statistical reports

  • Preparing reports for regulatory authorities

  • Capable of adapting to change and quickly learning new skills and concepts

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 [Register to View] 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.

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Current Contingent Workers apply [Register to View]

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 [Register to View] 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:

Travel Requirements:

Flexible Work Arrangements:

Shift:

Valid Driving License:

Hazardous Material(s):

Number of Openings:

1

Requisition ID:R131907