Silgan Unicep · 1 day ago
Laboratory Manager
Spokane, WA
Full-time
Onsite
Senior Level
5+ years expSilgan Unicep is seeking a Laboratory Manager to oversee the operational activities of their microbiology and analytical labs. The role involves ensuring compliance with quality and regulatory requirements, coordinating testing, and managing stability studies.
IndustrialManufacturingPackaging Services
Responsibilities
Plan, direct and coordinate the day-to-day operational activities of the microbiology and analytical labs
Coordinate testing with outside laboratories
Work with Finance and Business Development for costing laboratory work
Develop and manage stability studies as needed
Provide data and analysis for Annual Product Reviews
Ensure compliance with applicable quality and regulatory requirements (qualified/trained staff, validated equipment, proper documentation practices, etc.)
Ensure test methods and production processes meet specified protocol or SOP requirements, are scientifically sound and are performed error-free
Oversee testing of utilities, raw materials, bulk products, and finished goods
Participate in audits by customers or regulatory agencies
Address observations or recommendations as well as implement corrective/preventive actions as needed
Notify Quality Management of out of specification test results and assist in the interpretation of what the results mean and how to proceed
Perform a failure investigation identifying root cause and take corrective/preventive action in the event of a failure
Meet customer expectations for timeliness of lab studies and product shipments
Analyze and resolve internal and/or external delays as well as identify trends, recommend improvements and implement improvement activities to achieve annual on-time objectives
Provide review and approval of product release documentation from the lab and support review and approval as needed for Certificates of Analysis and Certificates of Compliance for customers
Provide exceptional customer service to internal and external customers
Regular onsite attendance
Adhere to company safety requirements
Other duties as assigned
Qualification
Required
Bachelor's degree in Chemistry, Microbiology, or a related field
5-10 years lab experience
Detailed knowledge of biohazard and USP requirements
Minimum 3 years' experience in an FDA regulated environment
Experience with ISO, GMP and GLP standards required
Experience with laboratory practices including pH testing and titrations
Knowledge of the scientific method, chemical products, test procedures, and composition of raw materials including detailed knowledge of chemical management and hazards
Knowledge of chemical terminology and units of measure
Ability to initiate, perform, and complete reports in a timely manner
Ability to work independently with little direction in a fast-paced environment
Good interpersonal skills
Ability to schedule projects and meet tight deadlines
Proficient in Microsoft Office
Company
Silgan Unicep
Silgan Unicep is a liquid contract manufacturer specializing in the mold and filling of unit-dose solutions. It is a sub-organization of Silgan Dispensing Systems.
51-200 employees
Funding
Current Stage
Growth StageCompany data provided by crunchbase