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Merck 2022 Co-op - External Manufacturing Quality Associate in Madison, New Jersey

Job Description

As a science-based healthcare company with a longstanding commitment to inventing and providing important medicines and vaccines, subject to applicable law, we require all U.S. and Puerto Rico based employees to be fully vaccinated for COVID-19, unless they have an approved medical or religious exemption or accommodation. We are committed to supporting our employees during this process as we work to ensure a safe and healthy work environment.

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 Manufacturing Division can provide you with great development and a chance to see if we are the right company for your long-term goals.

Our Company is a global health care leader with a diversified portfolio of prescription medicines, vaccines and consumer health products, as well as animal health products. Today, we are building a new kind of healthcare company – one that is ready to help create a healthier future for all of us. Our ability to excel depends on the integrity, knowledge, imagination, skill, diversity and teamwork of people like you. To this end, we strive to create an environment of mutual respect, encouragement and teamwork. As part of our global team, you’ll have the opportunity to collaborate with talented and dedicated colleagues while developing and expanding your career.

Animal Health External Manufacturing Quality (AH-EMQ) is an organization of approximately 45 professionals with the common objective of compliant, competitive, and quality oversight of goods & services from leading suppliers and partners that deliver a competitive advantage to our company.

The primary purpose of the position is to support various functional areas within AH-EMQ in ensuring compliance to applicable international and local GMP requirements and the requirements of our company Animal Health Quality Manual or other internal agreed standards.

The incumbent will report to the Veterinary Device Quality Lead and is a member of the Quality External Manufacturing team assisting with total quality performance and oversight operations of Contract Manufacturing Organizations (CMOs).

Responsibilities:

· Receive and analyze results for stability studies against target dates and report results for the purposes of regulatory submissions and annual reviews.

· Conduct quality review of customer complaints for veterinary devices and other products, including but not limited to review of new complaints, communicating with relevant CMO partners, review investigation reports, and close complaint records.

· Develop trend reports and prepare presentation of findings.

· Review business processes and system capabilities to initiate and lead improvement projects.

· Support other members of EMQ as needed with data entry tasks, including but not limited to initiation of change control and deviation management in the GMP system.

· Maintain accurate and timely records in various quality systems.

· Support Quality metrics as required.

· Other duties as assigned

Required Education and Experience:

  • Candidates must be pursing a Bachelors degree or Master in Science, Engineering (or equivalent).

  • Candidate must be available to work full-time for up to (6) months.

  • Candidates must be highly organized individual with attention to detail and accuracy with the ability to exercise initiative, flexibility, tact, and independent judgment.

  • Candidates must have excellent oral and written communication skills.

  • Must have excellent problem-solving skills, based on science, facts, data and understanding of the regulatory requirements in evolving environments.

  • Candidates must be proficient with Microsoft Excel, Microsoft PowerPoint, SharePoint.

  • Candidates must have a high degree of flexibility and adaptability to deal with ambiguous and dynamic situation.

  • Candidates must have the ability to manage multiple priorities in a fast-paced environment

  • Candidates must have proven organizational and time management skills.

Preferred Skills and Experience:

  • Candidates should have knowledge of pharmaceutical GMP principles and experience with Quality Systems and Quality Assurance.

  • Candidates should have demonstrated experience handling quality reports and trending product complaints, deviations, and change control management.

  • Candidates should have the ability to use electronic systems (document management, quality systems, Tracelink)

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 …

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

#AH2022

MAH2022

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:

Travel Requirements:

Flexible Work Arrangements:

Shift:

Valid Driving License:

Hazardous Material(s):

Number of Openings:

1

Requisition ID: R150756

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