Scalence L.L.C. · 1 day ago
Senior Specialist, Lab Services
Cincinnati, OH
Full-time
Onsite
Mid, Senior Level
$30/hr - $33.29/hr
4+ years expScalence L.L.C. is seeking a Senior Specialist in Lab Services to provide quality assurance support for QC Lab Operations. The role involves ensuring compliance with regulations, coordinating lab activities, and leading quality improvement initiatives.
Information Technology & Services
Responsibilities
Serve as compliance specialist for the QC lab including routine assessment of lab compliance, monthly communication to lab management regarding compliance concerns, ensure lab managers complete quarterly LIR and data review checklists, and serve as coordinator for any lab specific audits as needed
Coordinate lab review of compendial changes to evaluate impact and assign verification testing as needed
Serve as calibration coordinator for lab including approval and scheduling of service requests, impact assessment of demand maintenance on instrument qualification status, assignment, review, and approval of instrument related investigations, and creation of workorders in Maximo to capture vendor visits/maintenance as well as adding new instruments and decommissioning old instruments as needed
Work collaboratively with multiple parties to ensure appropriate instrumentation is procured, installed, calibrated and qualified according to company procedures
Perform assessments of QC documents (i.e. methods, qualification protocols, calibration documents, etc.) to determine compliance to processes and regulations to identify potential gaps. Mitigate and implement improvements within the quality system
Lead project teams in planning, preparation, review, and approval of quality documentation related to calibration requests
Participate on validation review board as area validation for equipment qualifications
Assist in the design of effective quality systems, procedures, and/or processes within cross functional teams to ensure compliance as well as efficiency throughout our quality system
May be asked to assist in development, revision, or implementation (including delivering training) of training modules, videos, and documents to the local and to global labs
Qualification
Required
GMP Lab Experience 6+ years
Documentation Review
Empower
LIMS
Electronic Lab Notebook
4+ years' experience in quality assurance, quality oversight or relevant experience
Strong oral and written communication skills
Good interpersonal skills
Preferred
Bachelor's Degree in Chemistry, Pharmacy, Biology, Microbiology, Engineering or other technical/ scientific area
Knowledge and familiarity with product testing, test method requirements, and capabilities of common lab instrumentation
Knowledge of QA systems and GMP compliance requirements including regulations and standards affecting device, biologics, and pharmaceutical products
Experience leading teams to deliver tactical results
Company
Scalence L.L.C.
In today’s dynamic and competitive market, success hinges on mastering three key areas: Data Intelligence, Business Resilience, and Digital Experience.
501-1000 employees
Funding
Current Stage
Late StageCompany data provided by crunchbase