What are the responsibilities and job description for the Specialist, Planning & Scheduling position at Merck?
Job Description
Global Clinical Supply Operations is seeking a highly motivated individual to support the clinical supply operations packaging organization; including first-line leader for day-to-day operations activities. Adherence to regulatory, global and site policies and procedures governing activities is critical.
The position is responsible for providing day to day tactical direction to the team of Clinical Packaging Technicians, ensuring that business objectives are met and that a high standard for Quality and Safety compliance is maintained. The position will also be expected to promote behaviors of continuous improvement and ensure that the Packaging team maintains an inclusive culture that supports positive employee relations.
Core Responsibilities
#eligibleforERP
GCSCareer
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.
About
We are an Equal Opportunity Employer, committed to fostering an inclusive and diverse workplace. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or other applicable legally protected characteristics. For more information about personal rights under the U.S. Equal Opportunity Employment laws, 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.
Learn more about your rights, including under California, Colorado and other US State Acts
U.S. Hybrid Work Model
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.
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
Job Posting End Date
02/5/2025
Global Clinical Supply Operations is seeking a highly motivated individual to support the clinical supply operations packaging organization; including first-line leader for day-to-day operations activities. Adherence to regulatory, global and site policies and procedures governing activities is critical.
The position is responsible for providing day to day tactical direction to the team of Clinical Packaging Technicians, ensuring that business objectives are met and that a high standard for Quality and Safety compliance is maintained. The position will also be expected to promote behaviors of continuous improvement and ensure that the Packaging team maintains an inclusive culture that supports positive employee relations.
Core Responsibilities
- Complete documentation according to Good Documentation Practices
- Perform administrative duties, as necessary (e.g. archiving, data entry/recording, metrics reports, etc.)
- Participate in walkthroughs of areas/processes to identify process improvements and ensure adherence to regulatory requirements.
- Author, review and approve SOPs related to operational changes.
- Author and/or participate in investigations of atypical events and clinical complaints, as needed.
- Work to prepare a room or batch for packaging activities, including the creation of appropriate Packaging documentation as needed.
- Coordinate complex packaging jobs and serve as technical contact for Packaging Technicians and Operations Planners as needed.
- Participate in continuous improvement initiatives across clinical supply operations
- Support daily (Tier) meetings to facilitate flow of information up/down through the organization
- Review Technician performance and system entries to ensure accuracy and compliance.
- Regularly help the team troubleshoot issues to minimize downtime and maintain product quality.
- Identify opportunities to improve the process (e.g. cycle times, ease of execution, reliability)
- Support work as needed to implement improvements (e.g. scheduling, staffing, protocol execution)
- 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.
- Train cross-functionally to support Distribution and Labeling activities based on operating model.
- Ensure correct documentation of transactions within SAP, and perform pre-execution and post-execution reviews of batch documentation.
- Track area performance related to Key Performance Indicators, and determine root cause and trending of misses.
- Participate in safety/regulatory audits (i.e. tours, topic discussion)
- Review area alarms and log completions to ensure compliance.
- Serve as an Subject Matter Expert to provide area/process overview information to visitors/auditors upon request
- Provide a leadership presence on the packaging floor.
- Champion standard work to drive consistent use of best practices.
- Represent Operations on project teams as needed.
- Ensure a culture of inclusion and consistency is maintained, supporting positive employee relations at the packaging floor level within the team and site.
- Assist packaging leadership team with development of objectives and ensure alignment with site goals.
- Facilitate regular huddle meetings to cascade information and collect team feedback.
- Provide regular feedback and coaching to employees on work performance.
- Escalate issues as needed to ensure the right support/awareness is given to issues as they arise
- Foster strong and effective safety culture on the team through actions, coaching, and prioritization.
- High School Diploma or equivalent required and minimum of 6 years’ experience Technical Operations, related Business Operations, or Good Manufacturing Practice (GMP) regulated environment, with specific experience in Clinical Pharmaceutical Packaging preferred.
- 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 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
- Ability to manage multiple priorities and coordinate people/resources to meet a production schedule
- Strong, strategic and effective interpersonal, communication, and problem-solving skills
- Experience with clinical manufacturing and/or packaging operations and demonstrated ability to deliver on a fluid demand schedule.
- SAP (or equivalent) experience
#eligibleforERP
GCSCareer
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.
About
We are an Equal Opportunity Employer, committed to fostering an inclusive and diverse workplace. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or other applicable legally protected characteristics. For more information about personal rights under the U.S. Equal Opportunity Employment laws, 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.
Learn more about your rights, including under California, Colorado and other US State Acts
U.S. Hybrid Work Model
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.
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
Job Posting End Date
02/5/2025
- 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.
Salary : $85,600 - $134,800
