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Merck 2022 Research & Development Quality Assurance Co-Op in West Point, Pennsylvania

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.

The Future Talent Program features Cooperative (Co-op) education that lasts up to 6 months and will include one or more projects. These opportunities in our Research Division can provide you with great development and a chance to see if we are the right company for your long-term goals.

Global Development Quality

Our Research & Development Division's Quality Assurance (QA) Global Development Quality (GDQ) group in West Point, PA is seeking a co-op student who will work collaboratively in a team environment to help advance quality throughout the drug development life cycle. Our Research & Development Division's Quality Assurance group is comprised of teams that maintain quality focus at each critical stage of development.

The role of Global Development Quality (GDQ) within QA is to ensure that clinical supplies are safe and manufactured with appropriate quality in compliance with regulatory requirements. GDQ does this by ensuring that there is a strong foundation of quality systems, qualification and validation of our facilities, equipment, and computer/automation systems, and tools to operate against. The group also manages product, document, and system life cycles.

Global Development Quality (GDQ) provides quality oversight of manufacturing, packaging and labeling, testing, and release of materials from early- to late-stage clinical trials conducted across the globe for small- and large-molecule (biologics and vaccines) development compounds, API/drug substance, drug product, and finished good within our internal and external networks.

The co-op position within GDQ will support the organization by assisting with important project-specific tasks to help us advance our operating model and enable new technology implementation with the goal of increasing our efficiency, agility and flexibility to ensure success in the dynamic development environment. These tasks may include but are not limited to project management, communication development, collaboration tool development, document management, documentation review, technical editing, meeting coordination and facilitation, training, onboarding, and other administrative tasks.

The position may be located at our West Point, PA site or Rahway, NJ site.

Clinical Quality

The Clinical Quality (CQ) team in our Research & Development Division's Quality Assurance (QA) organization is seeking 1 co-op who will work collaboratively in a team environment to help advance quality throughout the drug development life cycle. Our Research & Development Division's QA organization is comprised of teams that ensure a quality focus at various stages of drug development. 

The role of CQ within QA is to ensure that our Company's clinical trials are executed according to Good Clinical Practices (GCP), in order to maintain the safety and well-being of our patients and the integrity/reputation of our Company's clinical research program. The CQ team plans and conducts audits of our clinical investigator sites to ensure that our Research & Development Division's trials are executed as required by regulations and our internal quality standards. To do this effectively and efficiently, the CQ team uses risk-based methods to plan and execute its audits, and leverages data from past audits to identify trends and address them in a proactive manner.

The co-op position within QA’s CQ team will support the organization by assisting with two key, on-going strategic efforts: 1) the use, optimization and automation of risk-based methods for audit selection; and 2) the use of our Quality Management System (QMS) tools and data to improve the way we trend quality data. These projects are integral components of the team’s efforts to continuously improve the methods we employ for audit data analysis, and the way we leverage data to compute the relative risk of our studies and clinical sites.

The skills needed to successfully contribute to these projects include an ability to analyze data and develop, test, and implement analytical methods which may include excel, and creation of dashboarding and metrics displays using analytical tools such as Spotfire and the Veeva Quality Vault Quality Management System. Additionally, this role will require the development of new and improved quality detection systems that ensure the devised quality processes are being used properly, which is key to the governance of our risk based, data-driven analytical model.

The position is anticipated to be located at our West Point, PA site.

The co-ops in QA will also have the opportunity to network with the QA Leadership Team, which will provide a broad perspective on quality throughout the drug development continuum. They will also:

  • Gain an understanding of the phases of drug development.

  • Gain an understanding of the importance of quality in ensuring the rights and well-being of patients and the welfare of animals; helping to meet the intent of global regulatory requirements through robust processes and procedures; and ensuring subject, company, and regulator ​​confid​ence, and public trust in our Company.​

  • Interact with employees who have broad experience across the pharmaceutical industry.

We are seeking co-op candidates with strong academic performance, communication skills, teamwork, and the ability to work in a multi-functional environment.

These are full-time positions. Housing subsidy is not available as part of this program and must be funded 100% by the student.

Required Education, Experience and Skills:

  • Candidates must be available to work full-time for up to six months beginning in the Spring of 2022.

  • Candidates must be pursuing an appropriate scientific or engineering field of study (e.g., Health Care, Health Science, Science, Engineering or Pharmacy)

  • Must have excellent written and verbal communication and interpersonal skills

  • Must have strong organizational skills

  • Must have demonstrated ability to take initiative and own deliverables

Preferred Experience and Skills:

  • Candidates should have proficiency with Microsoft Office tools (Outlook, Word, Excel, PowerPoint)

  • Candidates should have Advanced Excel, Word, PowerApps, Photoshop, Illustrator, or InDesign skills preferred

  • Candidates should have Organizational and Business coursework such as Marketing, Communications

  • Candidates should have Project Management Skills

  • Candidates should have experience with document management systems (e.g., FirstDoc, Veeva, Documentum, SharePoint) preferred

We are a research-driven biopharmaceutical company. Our mission is built on the simple premise that if we “follow the science” that great medicines can make a significant impact to our world. We believe that a research-driven enterprise dedicated to world-class science can succeed by inventing medicine and vaccine innovations that make a difference for patients across the globe.

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.

FTP2022

MRL2022

Current Employees apply HERE (https://wd5.myworkday.com/msd/d/inst/1422$1533/rel-task/3001$14.htmld)

Current Contingent Workers apply HERE (https://wd5.myworkday.com/msd/d/task/1422$4020.htmld)

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 (https://survey.sogosurvey.com/r/aCdfqL) if you need an accommodation during the application or hiring process.

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

EEOC Poster (https://www.dol.gov/sites/dolgov/files/ofccp/regs/compliance/posters/pdf/eeopost.pdf)

EEOC GINA Supplement​

OFCCP EEO Supplement (https://www.dol.gov/ofccp/regs/compliance/posters/pdf/OFCCP_EEO_Supplement_Final_JRF_QA_508c.pdf)

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.

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:

Intern/Co-op (Fixed Term)

Relocation:

No relocation

VISA Sponsorship:

No

Travel Requirements:

No Travel Required

Flexible Work Arrangements:

Not Specified

Shift:

Valid Driving License:

Hazardous Material(s):

Number of Openings:

2

Requisition ID: R144938

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