Specialist Quality Control
About The Position
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.
Requirements
- 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.
- 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.
Nice To Haves
- 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.
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.
Benefits
- medical, dental, vision healthcare and other insurance benefits (for employee and family)
- retirement benefits, including 401(k)
- paid holidays
- vacation
- compassionate and sick days
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
