Senior Specialist, Quality Control

MSD•Wilson, NC

3d•Onsite

About The Position

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

Requirements

Bachelor of Science degree, preferably in Chemistry, Biology, or Engineering
≥ 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, GMP's, Government regulations
Experience with analytical instrumentation (HPLC, GC, Dissolution, KF, etc.)
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

Nice To Haves

Current Employees apply HERE
Current Contingent Workers apply HERE
US and Puerto Rico Residents Only
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 place, introductions are position specific. Please, no phone calls or emails.

Responsibilities

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 PM's.
Maintains equipment histories.
Analyzes equipment & preventive maintenance effectiveness.
Tracks maintenance metrics.
Maintain positive vendor relations and support review/completion of vendor services.
Assures compliance with FDA & GMP regulations.
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.
Serve as the site's Empower CDS coordinator, including validation and maintenance of site master data including custom fields, reports, instrument methods, sample sets and method sets in accordance with global procedures and applicable pharmacopeia.
Collaborate with DLR and GLIMS teams on creation and management of digital methods.
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.
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.
Uses Root Cause Analysis tools to identify true root cause for quality and safety events.
Authors, reviews, approves and/or participates in quality investigations.
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.