Senior Specialist Quality Control

MSD; Upper Gwynedd Township (Montgomery County); Vor Ort; USD 95.000 - 130.000; Vollzeit

Zusammenfassung

MSD is seeking a Senior Specialist for the WPLO ESG IPT Lead role to oversee equipment lifecycle, qualification, and maintenance across assigned Lab areas. You will coordinate IPT projects, manage calibration data, and act as primary contact for ESG IPT lab operations with a strong customer focus.

The position emphasizes risk-based asset management, cross-functional collaboration, and process improvements to support regulatory readiness and productivity in a GMP environment.

Qualifikationen

• Bachelor’s degree in life sciences, engineering or business; required.
• 4+ years in GMP manufacturing or regulated field for Bachelor’s degree holders.
• 2+ years in GMP manufacturing or regulated field for Master’s degree holders.

Aufgaben

• Coordinate IPT projects for assigned Lab areas and serve as IPT Lab Lead liaison.
• Qualify, implement, manage and decommission equipment; maintain calibration databases.
• Support regulatory inspections and write response reports as needed.
• Lead cross-functional meetings and drive corrective actions.

Kenntnisse

GMP experience

Project management

Root cause analysis

Quality decision making

Cross-functional collaboration

Communication

Leadership

Ausbildung

Bachelor's degree in life sciences/engineering/business

Master's degree

Tools

MPS 8-step Problem Solving

Regulatory documentation tools

Jobbeschreibung

Job Description

Job Description:

The Senior Specialist, WPLO Equipment Support Group (ESG) Senior Specialist IPT Lead is responsible for the implementation, life cycle management, and administration of laboratory equipment utilized within assigned areas of Laboratory Operations. Responsibilities include provide technical expertise to support run the business daily activities Leverage the RBAM (Risk Based Asset Management) process to assess high / medium risk equipment, collaborate with the Small Capital POC to work on forecasts to align funds for future risk mitigation, lead projects, implement operational improvements, support and / or have oversight over instrument qualification and implementation, and decommissioning. The ESG Senior Specialist IPT Lead is responsible for being the single point of contact for their assigned IPT Lab areas and is accountable to ensure strong Customer Focus and support.

Primary Activities:

• Primary activities include, but are not limited to:
• Act as the primary facilitator to coordinate the IPT projects in respect to assigned Lab areas.
• Function as the liaison between ESG IPT and IPT Lab Leads to focus on customers’ demands.
• Ensure work is prioritized and provide visibility of obstacles for project completion and timelines to Lab Leads.
• Attend the Lab Lead Tier meetings to ensure continuous and clear communication.
• Qualify, implement, manage and decommission equipment.
• Create PMs and actively update calibration and equipment databases as necessary.
• Author SDLC documentation.
• Initiate Deviation reports and provide assistance to Deviation Management with associated investigations
• Identify and assist in the implementation of Corrective and Preventative actions to support reoccurrence of atypical events
• Facilitate cross functional meetings for equipment implementation as needed.
• Works directly with the Equipment, Maintenance and Utilities team to prioritize and schedule preventative and corrective maintenance
• Complete parts purchase orders as needed.
• Assist with service contract negotiations with associated vendors.
• Provide coaching and guidance to new personnel and Quality Specialists.
• Provide support to Regulatory Agency inspections as needed and author or support writing response reports as necessary.
• Help facilitate training and work assignments for contractors assigned to that specific ESG IPT area.
• Ability to Lead a project across multiple workstreams.

Education Requirement:

• Bachelor’s degree in: life sciences, scientific discipline, engineering or business required.

Required Experience and Skills:

• For candidates with Bachelor’s degree, a minimum of 4 years of experience in GMP Manufacturing environment, Pharmaceutical/Biological Quality, Operation, Technical, or Regulatory function supporting manufacturing or testing operations, or related industry experience in laboratory, manufacturing, science related or regulated field.
• For candidates with Master’s degree, a minimum of 2 years of experience in GMP Manufacturing environment, Pharmaceutical/Biological Quality, Operation, Technical, or Regulatory function supporting manufacturing or testing operations, or related industry experience in laboratory, manufacturing, science related or regulated field.

Preferred Experience and Skills:

• MPS experience - 8–step Problem Solving.
• Demonstrated experience with root cause analysis tools.
• Demonstrated quality decision making.
• Self-starter with capability to develop innovative solutions and challenges.
• Proven analytical aptitude, critical thinking skills and ability to apply key concepts.
• Speaks with courage and candor.
• Strong written and verbal communication skills.
• Project management experience.

Required Skills:

Adaptability, Adaptability, Coaching, Competency Development, Competency Management, Corrective Action Management, Customer Centricity, Customer-Focused, Decision Making, Detail-Oriented, Equipment Ordering, Forensic Chemistry, Good Manufacturing Practices (GMP), Laboratory Operations, Life Cycle Planning, Logical Thinking, Overcome Obstacles, Product Ordering, Quality Standards, Regulatory Management, Root Cause Analysis (RCA), Root Cause Identification, Root Cause Investigations, Service Contracts, Task Allocation {+ 1 more}

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 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:

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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.

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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

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:

No Travel Required

Flexible Work Arrangements:

Not Applicable

Shift:

1st - Day

Valid Driving License:

No

Hazardous Material(s):

N/A

Job Posting End Date:

10/21/2026

*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.