Associate Specialist, Planning & Scheduling Clinical Supply Operations Onsite

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 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:

• Bachelors 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:

Preferred Skills:

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.

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 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 anothers thinking and approach problems collectively.

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

The primary location for this posting is:

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

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

This range reflects the Companys reasonable expectation of the base salary applicable to this role at the time of posting. An employees 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 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

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:

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Shift:

Valid Driving License:

Hazardous Material(s):

Job Posting End Date:

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