Associate Specialist, Quality Control, Lab Support

Job description

Job Description Position Responsibilities: • 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 NeedsExecute | 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 LandscapeDiverse 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 worldValues 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 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. Minimum Education Requirements • Bachelor of Science degree, preferably in Chemistry, Biology, or Engineering Required Experience and Skills • 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} 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 o