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

Caraway Therapeutics; Rahway (NJ); On-site; USD 65,000 - 103,000; Full time

Benefits offered by this job

Health benefits

401(k)

Paid holidays

Vacation

Job summary

Caraway Therapeutics, Inc. in Rahway, NJ is seeking an Associate Specialist, Packaging to support clinical supply packaging operations.

You will work with supervisors to prepare rooms and batches, document SAP transactions, and ensure GDP-compliant records for inspection readiness. The role emphasizes regulatory compliance, cross-functional collaboration, and continuous improvement to optimize packaging efficiency and quality.

Qualifications

• Bachelor’s degree required; degree in operations management, engineering, supply chain or related field preferred.
• One or more years in technical operations or GMP-regulated environments; clinical packaging experience preferred.
• Proficient with Microsoft Office and data/documentation practices.

Responsibilities

• Prepare rooms and batches for packaging operations with supervisors and technicians.
• Document SAP transactions and review batch records pre/post execution.
• Maintain inspection readiness and support regulatory compliance.
• Contribute to incidents and investigations as needed.
• Participate in continuous improvement and CAPA activities.
• Support KPI monitoring, trend analysis, and root cause investigations.
• Collaborate with Quality, Label Room, Distribution Center, Planning, and Master Planning.
• Complete GDP-compliant documentation and maintain training compliance.
• Handle archiving, data entry, and metrics reporting.

Skills

GMP experience

Clinical packaging

Microsoft Office

Detail-oriented

Education

Bachelor's degree

Operations management/engineering/supply chain degree preferred

Tools

SAP

Job description

Job Description

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

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.

The primary location for this posting is:

USA - New Jersey - Rahway

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 location(s):

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.

Additional location(s) Compensation Information:

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.