Associate Specialist, Quality Control, Lab Support

MSD•Wilson, NC

6d•$65,100 - $102,500•Onsite

About The Position

We are seeking a Growth and Improvement minded Technical Support Associate 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

Prior experience in a pharmaceutical laboratory setting
Knowledge and experience of CMMS systems is essential, ideally SAP
Experience managing vendors and contractors
Working knowledge of cycle time and inventory management, GMP's, Government regulations
Adaptability
Analytical Problem Solving
Aseptic Manufacturing
Auditing
Contractor Management
Corrective Action Management
Corrective Maintenance
Data Analysis
Environmental Monitoring
Equipment Reliability Improvement
GMP Compliance
Inventory Management
Inventory Planning
Laboratory Instrumentation
Laboratory Operations
Laboratory Testing
Maintenance Planning
Maintenance Planning Software
Oncology
Preventive Maintenance
Process Improvement Projects
Quality Control Inspection
Raw Material Testing
Regulatory Compliance

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

Responsibilities

Responsible for advanced preparation of maintenance jobs
Responsible for maintaining equipment 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
Demonstrates mastery of all maintenance management programs (Inventory Control, Calibration Program, Preventive Maintenance Program, SAP, Work Order Control, etc.)
Maintain positive vendor relations and support review/completion of vendor services
Assures compliance with FDA & GMP regulations
Demonstrates the ability to influence a team (including Global Support and Outside Vendors) in the effort to solve and execute corrective maintenance work and complete preventative maintenance work
Is a recognized resource to others when developing new maintenance reports, standards, and metrics
Provides input in the management of Maintenance and Repair Budgets
Implements cost saving initiatives
Uses vast experience in maintenance to conduct in-depth review of maintenance planning responsibilities to suggest and implement process improvement ideas
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
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
Attends departmental and team meetings focused on equipment/process improvement
Serves as liaison between NASU teams, Leadership, and External Vendors
Ability to interpret our 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