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Specialist, (Quality Risk Management) QRM Risk Lead

Job Description

Are you looking for an exciting opportunity with a rapidly growing pharmaceutical manufacturer? If so, then this is the opportunity for you!

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.

Position Description

The Specialist within the Quality Risk Management (QRM) group will support QRM activities at the Elkton site.  Work is executed as an individual contributor or as part of a project team.   The Specialist:

  • Responds to non- standard requests from customers; investigates with assistance from others as needed
  • Explains information and persuades others in straightforward situations
  • Makes decisions within guidelines and policies that impact own priorities and allocation of time to meet deadlines

The following are key responsibilities within this position:

  • Responsible to develop and maintain Quality Risk Management (QRM) Expertise
  • Responsible for supporting QRM site deployment
  • Responsible for activities involved in the implementation of a harmonized QRM program including standards, business processes, tools and training for the site
  • Responsible for facilitation of Quality Risk Assessments
  • Responsible for partnering with customers across site, key stakeholders and management, to communicate/escalate and ensure timely and adequate management of quality risks
  • Responsible for maintenance of Site Quality Risk tracking documentation 
  • Responsible for identifying and implementing continuous improvement initiatives within the site QRM business processes in alignment with the QRM CoE program, including integration into the quality management system
  • Accountable for review of site level QRM activities
  • Accountable for on-time schedule-based risk reviews
  • Accountable for ensuring that all those involved in QRM activities meet QRM training requirements
  • Support the QRM IT Tool Implementation at the site
  • Support regulatory inspections and audits as requested
  • Collaborates with QRM Community of Practice members across the division
  • Maintains knowledge relating to core internal procedures and applicable regulations (domestic and international). Reviews regulatory citations and other pertinent information.
  • Participates on, or leads teams supporting internal functions and/or evaluating site processes for improvement opportunities.

Education Minimum Requirement:

  • Bachelor's degree in engineering or related scientific field

Required Experience and Skill:

  • A minimum of two (2) years in GMP Manufacturing, Quality, Regulatory, or Process Engineering
  • Technical understanding of Biologics, Vaccines, and/or small molecules business
  • Strong GMP quality systems knowledge

Preferred Experience and Skills:

  • Exposed to application of Risk Management tools and methodologies such as: Failure Mode and Effect Analysis (FMEA) PHA, FTA, Risk Ranking and Filtering, etc. 
  • Fast learner and can be a change agent
  • Understanding of our Company’s Quality System
  • Shop floor manufacturing experience
  • Project Management experience
  • Demonstrated interpersonal skills including flexibility, collaboration and inclusion skills, and ability to work in a team environment
  • Demonstrated self-starter with capability to develop innovative solutions to challenges
  • Demonstrated facilitative leadership skills and ability to lead cross-functional project teams to deliver results
  • Proven analytical aptitude, critical thinking skills, and ability to apply key concepts
  • Speaks with courage and candor
  • Strong written and verbal communication skills
  • In-depth working knowledge and application of GMPs/GLPs
  • Proven ability to manage multiple projects simultaneously

MMDHJ

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.

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

Domestic

VISA Sponsorship:

No

Travel Requirements:

10%

Flexible Work Arrangements:

Shift:

1st - Day

Valid Driving License:

Hazardous Material(s):

Number of Openings:

1

Requisition ID:R38972

Specialist, (Quality Risk Management) QRM Risk Lead

Elkton, VA 22827
Full Time

Published on 03/20/2020