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Merck & Co, Inc

West Point Quality Line Oversight Program | January / April 2023

Science and Research

Environmental Program Manager

No

West Point, Pennsylvania, United States

Job Description

New hires based in the US & Puerto Rico will be required to demonstrate that they have been fully vaccinated for COVID-19 or qualify for a medical or religious exemption or accommodation to this vaccination requirement, subject to applicable law.

Job Description - Associate Specialist, Quality Line Oversight

Our Quality Assurance group ensures our products are manufactured, processed, tested, packaged, stored and distributed in alignment with our incredibly high standards of quality and meet 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.

The Quality Line Oversight Program at West Point focuses on early career talent development providing hands-on experience in pharmaceutical quality assurance supporting our Company’s largest and most complex vaccine manufacturing plant site. This program also supports opportunities to further learn, upskill, and network within different parts of the business outside of the primary responsibilities for career development purposes.

The targeted start date for this position will be in [Month/Year].

The program duration is approximately 18 months and will be a direct manufacturing support role primarily on the shop floor within our Quality Line Oversight team. This team rotates through the vaccine filling and packaging departments at the West Point site providing quality and compliance oversight to our 24/7 manufacturing operations.

Primary responsibilities involve:

  • Quality checks of finished product including visual inspection of vials, syringes and packages
  • Verification of appropriate line clearance between batches to prevent product mix-ups
  • GMP document / batch record review

Additional responsibilities include:

  • Internal/external audit support
  • Continuous improvement projects by partnering with Operations, Technology, and/or other Quality groups in areas such as safety, quality, and efficiency

The shift structure for the position includes 12-hour day and night shifts which rotate approximately every two months. The position does require weekend coverage.

This is an entry level position, and 0-2 years of experience in pharmaceutical industry through internships, co-operative education or other roles is preferred.

GENERAL PROFILE:

  • Contributes to the performance and results of a vaccine manufacturing department.
  • Provides regulatory, quality and compliance guidance.

BUSINESS EXPERTISE:

  • Applies technical, collaboration and interpersonal skills to align activities with department objectives.

FUNCTIONAL EXPERTISE:

  • Works as a team member on shop floor core tasks, quality systems activities and/or process improvement projects.
  • Has ability to examine an issue from diverse perspectives (safety, compliance, automation, equipment, process, and people) in order to best understand and resolve the root cause.
  • Assures consistent application of standardized work, process tools, and procedures.
  • Assists with regulatory inspections in either documentation area, request management area or inspection room.
  • Provides quality guidance to technical and manufacturing documents necessary for investigations, process design/definition, engineering studies, process demonstrations, change control and validation.
  • Effectively collaborates with peers on site and above site as required.

Education Minimum Requirement:

  • B.S. Degree in Engineering or Sciences

Required Experience and Skills:

  • Willing to work alternate shifts and weekends
  • Ability to focus on and obtain results
  • Good verbal and written communication skills
  • Ability to effectively collaborate within and across an integrated manufacturing team
  • Ability to enact conflict resolution
  • Ability to effectively respond to change
  • Excellent analytical and organizational skills
  • High personal integrity, credibility and energy
  • Flexibility to perform related tasks to support the business
  • Computer literacy in MS Office, Word, Outlook, Excel

Preferred Experience and Skills:

  • 0-2 years working experience in cGMP pharmaceutical environment
  • Experience using Lean/Six Sigma tools

Schedule Requirements

  • 12 hour day and night shifts which rotate approximately every two months | Weekend coverage

Our Manufacturing & Supply Division is dedicated to being the most trusted supplier of biopharmaceuticals 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., Rahway, 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.

Residents of Colorado

Click here to request this role’s pay range.

FTP2023

For positions located in the United States and Puerto Rico – Subject to applicable law, all new hires (including internal transfers) must demonstrate that they are fully vaccinated against COVID-19 or that they qualify for a medical or religious exemption to this vaccination requirement. New hires (including internal transfers) to a position that, as determined by the Company, requires routine collaboration with external stakeholders (such as roles in health services or customer-facing commercial or research-based roles) (“Customer-Facing Role”) who are not vaccinated must qualify for a medical or religious exemption and be in a position that the Company determines can accommodate unvaccinated employees without causing an undue burden to business operations. If, following dialog with the candidate as appropriate, it is determined that the candidate either a) does not qualify for a religious or medical exemption or, b) for candidates applying for Customer-Facing roles, it is determined that allowing the candidate to work without vaccination would cause an undue burden to the Company, the candidate will be ineligible for hire or transfer, or any offer of employment or transfer (if applicable) will be revoked. Please note that notwithstanding the approval of any reasonable accommodation, the Company reserves the right to monitor, modify, or revoke any such accommodation if it is determined, following dialog with the employee, that the accommodation is no longer effective or results in an undue burden to the Company.

Current Employees apply HERE

Current Contingent Workers apply HERE

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 if you need an accommodation during the application or hiring process.

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

EEOC Know Your Rights

EEOC GINA Supplement​

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.

Residents of Colorado:

Click here to request this role’s pay range.

Learn more about your rights, including under California, Colorado and other US State Acts

Search Firm Representatives Please Read Carefully
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, 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:

No Travel Required

Flexible Work Arrangements:

Not Specified

Shift:

1st - Day, 2nd - Evening, 3rd - Night

Valid Driving License:

No

Hazardous Material(s):

Number of Openings:

10

Requisition ID:R163329