Hiring company: Merck
Job Description
Subject to applicable law, all prospective hires will be required to demonstrate that they have been fully vaccinated for COVID-19 or intend to be vaccinated for COVID-19 by November 1, 2021, or qualify for a medical or religious accommodation to this vaccination requirement. Hired candidates who are not vaccinated by November 1, 2021, and who have not been approved for a legally-required medical or religious accommodation will be subject to disciplinary action up to and including termination of employment, in accordance with applicable law.
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.
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.
Position Qualifications:
Education Minimum Requirement:
B.S. degree in engineering or related scientific field
Required Experience and Skills:
A minimum of 2 years in GMP Manufacturing, Quality, Regulatory, Process Engineering
Technical understanding of Biologics, Vaccines, and/or small molecules business
Strong GMP quality systems knowledge
Preferred Experience and Skills:
A minimum of 1 year shop floor manufacturing experience in production, technical or quality support role
Exposed to application of Risk Management tools and methodologies such as: FMEA, PHA, FTA, Risk Ranking and Filtering, etc.
Fast learner and can be a change agent
Understanding of our Company’s Quality System
Project Management experience with Proven ability to manage multiple projects simultaneously
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
Our Manufacturing & Supply Division is dedicated to be 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.
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
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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.
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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:
RegularRelocation:
DomesticVISA Sponsorship:
NoTravel Requirements:
10%Flexible Work Arrangements:
TelecommutingShift:
1st - DayValid Driving License:
Hazardous Material(s):
Number of Openings:
1