Senior Specialist, Quality Control

Job description

Job Description 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 Summary, Focus and Purpose The Technical Support Senior Specialist is 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, and tracks maintenance metrics. They demonstrate mastery of analytical and maintenance management programs (SAP, EAM, GLIMS, Empower, eShopFloor, LabX, etc.). Maintain positive vendor relations and support review/completion of vendor services. Assures compliance with FDA & GMP regulations. Is a recognized resource to others and demonstrates the ability to influence a team in the efforts to manage routine and project-based work. 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. A core function for this role will be to serve as the site's Empower CDS coordinator. This entails validation and maintenance of site mater data including custom fields, reports, instrument methods, sample sets and method sets in accordance with global procedures and applicable pharmacopeia. The Empower coordinator is expected to collaborate with DLR and GLIMS teams on creation and management of digital methods. This position is being posted with an expected start date of January 2027. 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 Independently manages equipment procurement, validation and qualification Manage and participate in analytical Method Transfer activities Information Transfer 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. 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 Familiarity of compendial requirements and their application to laboratory testing and equipment 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 Minimum Education Requirements Bachelor of Science degree, preferably in Chemistry, Biology, or Engineering Required Experience and Skills ≥ 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.) Required Skills: Adaptability, 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 {+ 8 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 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