Associate Specialist, Planning & Scheduling - Clinical Supply Operations - Onsite

Merck & Co.

Rahway (NJ)

Presencial

USD 65.000 - 103.000

Jornada completa

Hace 3 días
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Ventajas ofrecidas por este puesto de trabajo

Medical, dental, vision benefits
401(k) retirement plan
Paid holidays and vacation

Descripción de la vacante

Merck & Co. in Rahway, NJ, seeks an Associate Specialist, Packaging to support clinical supply packaging operations.

You will partner with Supervisors and Senior Packaging Technicians to prepare rooms and batches for packaging, ensuring GDP-compliant documentation and accurate SAP transactions. The role emphasizes inspection readiness, continuous improvement, and CAPA support, with a Bachelor's degree and GMP-regulated experience as preferred qualifications.

Formación

  • Bachelor's degree required.
  • Degree or coursework in operations management, engineering, supply chain or related technical field preferred.

Responsabilidades

  • Partner with Supervisors and Senior Packaging Technicians to prepare rooms and batches for packaging.
  • Ensure accurate SAP transactions and review batch records before and after execution.
  • Support inspection readiness through routine walkthroughs and regulatory compliance checks.
  • Draft and/or contribute to incidents of atypical events and clinical complaints as needed.
  • Participate in continuous improvement initiatives to boost efficiency and compliance.
  • Support CAPAs from walkthroughs and investigations and drive root cause analyses.
  • Monitor KPIs, assess trends, and support corrective actions for missed targets.
  • Collaborate with Quality, Label Room, Distribution Center, Operations Planning, and Master Planning.
  • Complete documentation per Good Documentation Practices (GDP).
  • Maintain training and compliance with site safety and quality requirements.
  • Handle archiving, data entry, recordkeeping, and metric reports.

Conocimientos

Interpersonal skills
Communication skills
Problem-solving
MS Office
Detail-oriented
Organization
Independent learning
cGMP knowledge
Data management
SAP experience

Educación

Bachelor's degree
Operations management/Engineering/Supply chain degree preferred

Herramientas

SAP
GMP systems

Descripción del empleo

Associate Specialist, Packaging

Summary:- Global Clinical Supply Operations (CSO) is seeking a motivated and detail-oriented Associate Specialist to support clinical supply packaging operations. In this role, you will partner closely with supervisors and cross-functional stakeholders to ensure clinical operation activities are executed in a compliant, efficient, and inspection-ready manner. A strong commitment to regulatory compliance, quality, and adherence to global and site-specific procedures is essential.

Core Responsibilities
  • Partner with Supervisors and Senior Packaging Technicians to prepare rooms and batches for packaging operations, including the development of required packaging documentation.
  • Ensure accurate execution and documentation of SAP transactions and perform pre-execution and post-execution reviews of batch records.
  • Support and maintain inspection readiness through routine walkthroughs of areas and processes to identify opportunities for improvement and ensure compliance with regulatory expectations.
  • Author and/or contribute to incidents of atypical events and clinical complaints, as needed.
  • Participate in continuous improvement initiatives to enhance operational efficiency and compliance.
  • Support corrective and preventive actions resulting from walkthrough observations and investigations, as needed.
  • Monitor area performance against key performance indicators (KPIs), assess trends, and support root cause analysis for missed targets.
  • Collaborate effectively with internal partner groups, including Quality, Label Room, Distribution Center, Operations Planning, and Master Planning.
  • Complete all documentation in accordance with Good Documentation Practices (GDP).
  • Maintain current training and compliance with site safety and quality requirements.
  • Perform administrative tasks as needed, including archiving, data entry, recordkeeping, and preparation of metrics reports.
Minimum/Preferred Education
  • Bachelor's degree.
  • A degree in operations management, engineering, supply chain, or related technical field is preferred.
Experience & Skills
  • One or more years' experience in Technical Operations, related Business Operations or GMP regulated environment, with specific experience in clinical packaging preferred.
  • Effective interpersonal and communication skills.
  • Demonstrated problem-solving skills.
  • Proficient in Microsoft Office (Word, Excel, etc.).
  • Detail-oriented and organization skills.
  • Ability to quickly learn and complete tasks independently with minimal guidance after training.
  • Knowledge of cGMPs, data management, collection and analysis.
  • SAP (or equivalent) experience strongly preferred.
Required Skills
  • Batch Production Records, Clinical Supplies Management, Compliance Packaging, Continuous Improvement Techniques, Detail-Oriented, Driving Continuous Improvement, Good Manufacturing Practices (GMP), Operational Efficiency, Pharmaceutical Packaging, SAP Products
Preferred Skills
  • Clinical Manufacturing, Inspection Readiness, Supply Chain Processes

As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics.--As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities.- For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:

EEOC Know Your Rights

EEOC GINA Supplement

We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively.

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

Primary Location

USA - New Jersey - Rahway

Salary Range

Where required by law, the compensation range for this role is provided below.

The salary range for the primary location of this role is:

$65,100.00 - $102,500.00

This range reflects the Company's reasonable expectation of the base salary applicable to this role at the time of posting. An employee's position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs. The successful candidate will be eligible for annual bonus and long-term incentive, if applicable.

We offer a comprehensive package of benefits. Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at https://jobs.merck.com/us/en/compensation-and-benefits .

Additional Locations

Please note the salary range above applies to the Primary Location of the position. Where a role has other listed locations, different compensation guidelines may apply. You may find the salary ranges for additional locations below. If the salary range is not listed for the location you are applying to, our Talent Acquisition team will provide further information to you relevant to your location.

San Francisco Residents Only

We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance

Los Angeles Residents Only

We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance

Employee Status

Regular

Relocation

No relocation

VISA Sponsorship

No

Travel Requirements

10%

Flexible Work Arrangements

Not Applicable

Shift

1st - Day

Valid Driving License

No

Hazardous Material(s)

No

Job Posting End Date

11/10/2026

*A job posting is effective until 11:59:59PM on the day BEFORE -the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.

Requisition ID

R423328

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