Senior Specialist, Quality Control

Job Description

Our Quality group ensures every single material inside our products is manufactured processed tested packaged stored and distributed in alignment with our incredibly high standards of quality and meets all regulatory requirements. Partnering across our internal manufacturing facilities external contract manufacturers and suppliers we create an interdependent global manufacturing network dedicated to delivering a compliant reliable supply of products to customers and patients on time every time across the globe.

• We are seeking a Growth and Improvement-minded Technical Support Senior Specialist in Quality Control that can help drive our Strategic Operating Priorities.
• Invent Pursue the Most Promising Internal and External Science to Address Significant Unmet Medical Needs
• Execute Prioritize Resources Behind Our Key Growth Drivers (Oncology Vaccines Select Specialty Areas Animal Health) While Optimizing Our Base Business)
• Adapt Develop Our People Culture and Business Model to Evolve with a Dynamic Landscape
• Diverse Talent We are committed to providing an inclusive and welcoming environment with supporting leadership behaviors because having a high performing engaged workforce is critical to our ability to deliver innovative solutions to patients and customers around the world
• Values and Standards Our Steadfast Commitment to Our Values and Standards will Continue to Guide Us as We Take on New Challenges and Will Always be Fundamental to Our Success They are a Competitive Advantage for Us

Summary Focus and Purpose

The Technical Support Senior Specialist is responsible for advanced preparation of maintenance jobs; responsible for maintaining instrumentation equipment and associated data preventive maintenance data and calibration data; processes change control for equipment and preventive maintenance documentation coordinates calibration program coordinates maintenance planning operations within the laboratory for consistency plans and schedules maintenance work orders schedules PMs maintains equipment histories analyzes equipment & preventive maintenance effectiveness and tracks maintenance metrics.

They demonstrate mastery of analytical and maintenance management programs (SAP EAM GLIMS Empower eShopFloor LabX etc.). Maintain positive vendor relations and support review/completion of vendor services. Assures compliance with FDA & GMP regulations. Is a recognized resource to others and demonstrates the ability to influence a team in the efforts to manage routine and project-based work. Provides input in the management of equipment related budget planning. Implements cost saving initiatives. Uses vast experience in analytical equipment and programs for troubleshooting and implementation of process improvement ideas.

A core function for this role will be to serve as the sites Empower CDS coordinator. This entails validation and maintenance of site mater data including custom fields reports instrument methods sample sets and method sets in accordance with global procedures and applicable pharmacopeia. The Empower coordinator is expected to collaborate with DLR and GLIMS teams on creation and management of digital methods.

This position is being posted with an expected start date of January 2027.

Key Functions

Development

Work Independently and as a Team member with Integrity Precision Accomplishment Motivational Ambition Respect Inclusion

Participate in development of objectives and ensures alignment with site goals

Laboratory Support

• Initiating/leading problem solving to identify short-term and long-term actions to prevent problem reoccurrence reduce laboratory downtime and increase equipment reliability
• Following standard work for escalation as it related to safety quality and downtime events
• Timely approval of qualification change control procedures and other documents
• Providing operational Subject Matter Expert support/direction for the installation of new equipment and/or modifications to existing processes and/or equipment
• Demonstrates a deep understanding of customer needs requirements and expectations.
• Pays close attention equipment use/maintenance and proactively steps in to help as needed.
• Maintains equipment preventative maintenance/calibration programs
• Independently manages equipment procurement validation and qualification
• Manage and participate in analytical Method Transfer activities

Information Transfer

• Attends departmental and team meetings focused on equipment/process improvement
• Serves as liaison between NASU teams Leadership Global network and External Vendors
• Ability to interpret company Quality Policies and Guidelines for daily application.
• Participates and/or directs Tier meetings
• Promotes teamwork and open discussion of issues.

Compliance

• Uses Root Cause Analysis tools to identify true root cause for quality and safety events
• Authors reviews approves and/or participates in quality investigations
• Familiarity of compendial requirements and their application to laboratory testing and equipment
• Participates in internal and external audits and inspections
• Identifies equipment-related trends and facilitates implementation of corrective actions
• Creates/Revises Standard Operating Procedures Forms and other equipment-related documents
• Understands and applies regulatory / compliance requirements including GMP NDA and related regulations and can interpret those regulations for implementation in the workplace.
• Acts as a QMS Topic Owner and/or supports QMS updates
• Manage and perform periodic review for access and orphan data in systems such as LabX Empower eShopFloor
• Authors owns approves SOPs Change Requests and other technical documents
• Manage and perform equipment periodic review to verify performance of instrumentation and equipment

Minimum Education Requirements

• Bachelor of Science degree preferably in Chemistry Biology or Engineering

Required Experience and Skills

• 4 years in a pharmaceutical laboratory setting
• High level of proficiency with Empower chromatography software preferably with experience in a coordinator role
• Knowledge and experience of CMMS systems is essential ideally SAP or EAM
• Experience managing vendors and contractors
• Working knowledge of cycle time and inventory management GMPs Government regulations
• Experience with analytical instrumentation (HPLC GC Dissolution KF etc.)

Required Skills:

Adaptability Adaptability Analytical Instrumentation Analytical Method Development Analytical Thinking Calibration Procedures Change Controls Decision Making Detail-Oriented Equipment Calibrations Equipment Implementation Equipment Maintenance Equipment Management Equipment Monitoring Equipment Qualification Forensic Chemistry Goal Setting Good Manufacturing Practices (GMP) Government Regulation Laboratory Information Management System (LIMS) Laboratory Operations Management Review Procedure Reviews Quality Standards Regulatory Audits 8 more

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:

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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 anothers thinking and approach problems collectively.

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

The salary range for this role is

$106200.00 - $167200.00

This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this 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 can apply for this role through (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting.

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:

Domestic

VISA Sponsorship:

No

Travel Requirements:

10%

Flexible Work Arrangements:

Not Applicable

Shift:

1st - Day

Valid Driving License:

No

Hazardous Material(s):

NA

Job Posting End Date:

10/13/2026

*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.