Specialist Quality Control

Job Description Job Description: The Specialist, WPLO Equipment Support Group (ESG) is responsible for the implementation, lifecycle management, and administration of laboratory equipment within assigned areas of Laboratory Operations. This position provides technical support for routine business activities and applies the Risk-Based Asset Management (RBAM) process to evaluate high- and medium-risk equipment. The incumbent partners with the Small Capital point of contact to develop forecasts and align funding for future risk mitigation, participates in projects as a lead or team member, and supports operational improvements, instrument qualification, implementation, and decommissioning activities. The Specialist serves as point of contact for assigned IPT laboratory areas and is accountable for maintaining strong customer focus and support. The Specialist – Quality Control, within Laboratory Operations and under the broad direction of the Director – Quality Control, is responsible for the implementation and management of laboratory equipment utilized within assigned laboratories. This role ensures operations are conducted in accordance with our Manufacturing Division and company safety policies and procedures, current Good Manufacturing Practice (cGMP) regulations, and departmental budget requirements. The incumbent may provide technical expertise and recommendations in support of company, divisional, and organizational initiatives, including capital requests, operational improvements, equipment replacement, and routine business activities supporting testing within Laboratory Operations. Primary Responsibilities: Support capital projects and coordinate equipment-related projects within the assigned area of Laboratory Operations. Partner with the Reliability Engineer to assess laboratory equipment risk and align capital planning with equipment replacement needs. Obtain vendor quotes, coordinate procurement of equipment, and establish equipment and job plans within systems such as SAP and ProCal (maintenance systems) Use ProCal and SAP to create job plans and complete required approvals, change controls, and system updates. Oversee initial operational qualification requirements as needed. Collaborate with Laboratory Operations, Equipment, Maintenance, and Utilities teams to prioritize and coordinate equipment removals, relocations, and installations. Provide input into contract negotiations and support vendor relationship management. Initiate and participate in equipment-related investigations and quality notifications to ensure compliance with cGMP and regulatory requirements, supporting the quality, safety, efficacy, and potency of our company products. Lead simple projects, such as like-for-like equipment changes, or serve as a contributor on more complex cross-functional projects. Education Minimum Requirement: BS/B.A or M.S in Biology, Biochemistry, Chemistry, Engineering, Microbiology, Virology or other associated field with a minimum of 0-2 years of relevant laboratory, manufacturing, biotechnology or quality control experience. Required Experience and Skills: Demonstrated interpersonal skills including flexibility, collaboration and inclusion skills, and ability to work in a team environment. Individual and team experience in a Quality or Manufacturing function. Demonstrated technical expertise in analytical testing methodology, equipment and software validation principles, as well as a general understanding of the operation and mapping of controlled temperature units. Preferred Experience and Skills: Proven analytical aptitude, critical thinking skills, and ability to apply key concepts. Speaks with courage and candor. Strong written and verbal communication skills. In-depth working knowledge and application of GMPs/GLPs. Ability to manage multiple projects simultaneously. Lead or participated in project management. Required Skills: Ability to Coordinate, Ability to Coordinate, Adaptability, Analytical Instrumentation, Analytical Thinking, Change Controls, Competency Management, Customer Centricity, Customer-Focused, Customer Support, Driving Continuous Improvement, Equipment Monitoring, Equipment Ordering, GMP Compliance, Laboratory Documentation, Laboratory Safety, Logical Thinking, Microbiological Analysis, Multitasking, Operational Quality, Team Communication, Team Organization, Teamwork, Technical Writing, Troubleshooting {+ 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 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 The primary location for this posting is: USA - Pennsylvania - West Point Where required by law, the compensation range for this role is provided below. The salary range for the primary location of this role is: $87,300.00 - $137,400.00 This range reflects the Company's reasonable expectation of the base salary applic