Associate Specialist, Quality Control, Lab Support

Merck•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. 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.

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:
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:
EEOC Know Your Rights
EEOC GINA Supplement 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.
Learn more about your rights, including under California, Colorado and other US State Acts
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

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.