"Alerted.org

Job Description

Summary:

Global Clinical Supply (GCS) Operations is seeking a highly motivated individual to support the clinical supply operations for packaging and label print, including first line leader for day-to-day activities. Working closely with the area lead(s), work within a team environment to train, coordinate, and/or execute clinical packaging and labeling activities, involving GMP documentation of operations. Serve as a liaison between GCS Operations and various partner groups to ensure consistent and compliant activities across Clinical Supply Operations. Adherence to regulatory, global and site policies and procedures governing activities is critical.

The position will also be expected to promote behaviors of continuous improvement and ensure that the team maintains an inclusive culture that supports positive employee relations.

Core Responsibilities:

+ Work with Technicians to prepare a room or batch for packaging and/or labeling activities, including the creation of appropriate documentation as needed.

+ Schedule and coordinate shop floor activities while serving as technical contact for the Technicians and Operations Planners as needed.

+ Support daily (Tier 1) meetings to promote visibility of information up/down through the organization to ensure the right support/awareness is given to issues as they arise.

+ Author, review, and approve Standard Operating Procedures (SOPs) related to site and global operations.

+ Author and/or participate in investigations of atypical events and clinical complaints, as needed.

+ Ensure correct documentation of transactions within SAP and perform pre-execution and post-execution reviews of batch documentation.

+ Participate in walkthroughs of areas/processes to identify process improvements and ensure adherence to regulatory requirements.

+ Execute Corrective/Preventative actions stemming from walkthrough observations and/or investigations, as needed.

+ Maintain training and compliance with site safety and quality requirements.

+ Partner with outside groups, including Quality, Label Room, Distribution Center, Operations Planning, Master Planning.

+ Complete documentation according to Good Documentation Practices.

+ Participate in continuous improvement initiatives for your respective area, including risk assessments.

+ Review area alarms and log completions to ensure compliance.

+ Represent Operations on project teams as needed.

+ Assist team with development of objectives and ensure alignment with site goals.

Education:

+ Bachelor’s Degree and a minimum of 2 years’ experience in Technical Operations, related Business Operations or Good Manufacturing Practice (GMP) regulated environment, with specific experience in Clinical Pharmaceutical Packaging.

Required Experience & Skills:

+ Ability to operate effectively independently and collaboratively within teams.

+ Operational environment under cGMPs.

+ Strong interpersonal, communication, organizational, and problem-solving skills, coupled with the ability to engage and influence cross-functional stakeholders

+ Detail-oriented and organization skills.

+ Ability to quickly learn and complete tasks independently with minimal guidance after training.

+ Manage multiple priorities.

+ Proficient in Microsoft Office (Word, Excel, Outlook, etc.)

Preferred Experience and Skills:

+ SAP (or equivalent) experience strongly preferred

+ Experience with clinical manufacturing and/or GMP packaging operations and demonstrated ability to deliver on a fluid demand schedule.

+ Coordinate people/resources to meet a production schedule.

\#GCSCareer

\#VETJobs

\#eligibleforERP

Current Employees apply HERE (https://wd5.myworkday.com/msd/d/task/1422$6687.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.

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 (https://www.eeoc.gov/sites/default/files/2022-10/22-088\_EEOC\_KnowYourRights\_10\_20.pdf)

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 (https://www.msdprivacy.com/us/en/CCPA-notice/)

Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, Monday - Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as “remote”.

The Company is required to provide a reasonable estimate of the salary range for this job in certain states and cities within the United States. Final determinations with respect to salary will take into account a number of factors, which may include, but not be limited to the primary work location and the chosen candidate’s relevant skills, experience, and education.

Expected US salary range:

$85,600.00 - $134,800.00

Available benefits include bonus eligibility, long term incentive if applicable, health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and sick days. A summary of benefits is listed here (https://www.benefitsatmerck.com/) .

**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:

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):

n/a

Required Skills:

Adaptability, Adaptability, Business Management, Business Operations, Clinical Supplies Management, Clinical Supply Chain Management, Clinical Trial Protocols, Cross-Functional Communications, Data Management, Detail-Oriented, Dispatching, Global Operations Management, GMP Compliance, Inventory Control Management, Logistics Coordination, Management Process, Manufacturing Compliance, Master Batch Records, Materials Procurement, Microsoft Office, Pharmaceutical Packaging, Production Coordination, Production Planning, Proper Documentation, Regulatory Requirements {+ 5 more}

Preferred Skills:

Job Posting End Date:

05/27/2025

*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:** R350008