Technical Support Associate Specialist, QC

• 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, The Technical Support Associate Specialist, QC is 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, and tracks maintenance metrics.

They demonstrate 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.

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

Information Transfer

• 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.

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
• 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.

Planning Oncology Auditing Teamwork Budgeting Chemistry Operations Leadership Management Innovation Compassion Reliability Calibration Adaptability Data Analysis Animal Health Change Control Prioritization Pharmaceuticals Problem Solving Quality Control SAP Applications Telephone Skills Inventory Control Vendor Management Internal Auditing External Auditing Planning Software Influencing Skills Laboratory Testing Inventory Planning Root Cause Analysis Process Improvement Motivational Skills Inventory Management Cycle Time Variation Contingent Workforce Regulatory Compliance Contractor Management Preventive Maintenance Maintenance Scheduling Corrective Maintenance Maintenance Coordination Environmental Monitoring Laboratory Instrumentation Standard Operating Procedure Good Manufacturing Practices Corrective Action Management Vendor Relationship Management Non-Disclosure Agreement (Intellectual Property Law), * Bachelor of Science degree, preferably in Chemistry, Biology, or Engineering, * 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

Required Skills: Adaptability, 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 {+ 1 more}, Oncology Auditing Teamwork Budgeting Chemistry Operations Leadership Management Innovation Compassion Reliability Calibration Adaptability Data Analysis Animal Health Change Control Prioritization Pharmaceuticals Problem Solving Quality Control SAP Applications Telephone Skills Inventory Control Vendor Management Internal Auditing External Auditing Planning Software Influencing Skills Laboratory Testing Inventory Planning Root Cause Analysis Process Improvement Motivational Skills Inventory Management Cycle Time Variation Contingent Workforce Regulatory Compliance Contractor Management Preventive Maintenance Maintenance Scheduling Corrective Maintenance Maintenance Coordination Environmental Monitoring Laboratory Instrumentation Standard Operating Procedure Good Manufacturing Practices Corrective Action Management Vendor Relationship Management Non-Disclosure Agreement (Intellectual Property Law) +0 Associate Specialist, Quality Control, Lab Support Merck & Co., Inc

Wilson, NC*On-Site

Biology Planning Oncology Auditing Teamwork Budgeting Chemistry Operations Leadership Management Innovation Compassion Reliability Calibration Adaptability Data Analysis Animal Health Change Control Prioritization Pharmaceuticals Problem Solving Quality Control SAP Applications Telephone Skills Inventory Control Vendor Management Internal Auditing External Auditing Planning Software Influencing Skills Laboratory Testing Inventory Planning Root Cause Analysis Process Improvement Motivational Skills Inventory Management Cycle Time Variation Contingent Workforce Regulatory Compliance Contractor Management Preventive Maintenance Maintenance Scheduling Corrective Maintenance Maintenance Coordination Environmental Monitoring Laboratory Instrumentation Standard Operating Procedure Good Manufacturing Practices Corrective Action Management Vendor Relationship Management

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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The salary range for this role is $65,100.00 - $102,500.00

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.