Analytical Lab Operations Specialist II
Position Summary
The Analytical Lab Operations Specialist II will support lab operations within the Quality Control and Analytical Development laboratories. Responsibilities include managing materials, equipment, third-party vendors, budget, documents, and quality events.
Job Responsibilities
Perform tasks associated with maintaining GMP-compliant quality control, analytical development, and stability laboratories as it pertains to sample management, equipment maintenance, material inventory, and other general lab operations needs
Perform sample management tasks (shipment, receipt, storage) in accordance with applicable regulatory requirements and Standard Operating Procedures (SOPs)
Schedule equipment maintenance and repair activities and capture documentation of services in the Computer Maintenance Management System (CMMS) in accordance with applicable regulatory requirements and Standard Operating Procedures (SOPs)
Support management and execution of Operational and Capital Expenditure budgets for Quality Control and Analytical Development Labs
Support initiation, review, and maintenance of contracts related to Quality Control and Analytical Development lab operations with Legal and IP departments in accordance with applicable regulatory requirements and Standard Operating Procedures (SOPs)
Act as Single Point of Contact with Third Party vendors, Project Managers, Material Depots and Producers, Material Shippers, and Analytical Development Project Leads to coordinate shipment and receipt of samples and other lab reagents and materials
Own, initiate, and author deviations, CAPAs, and Change Controls related to all GMP operations and processes
Author new SOPs and revise existing SOPs as needed
Support continuous improvement of lab operations procedures by independently identifying process gaps
Participate in data review processes to ensure accuracy and completeness of information
Interact with regulatory agencies as the subject matter expert for lab operations related inquiries, including sample management, equipment management and maintenance, and reagent and consumable inventory management
Minimum Requirements
Bachelor’s degree and minimum 2 years of relevant industry experience
Experience in regulated GMP laboratory within the pharmaceutical or biotech industry
Experience independently owning and authoring GMP quality events (i.e. deviations, CAPAs, change controls, etc.)
Strong technical writing skills
Ability to handle multiple projects/teams simultaneously
Ability to work independently in a fast-paced, highly interactive environment with minimal supervision
Excellent verbal and written communication skills
Ability to build open and collaborative relationships and work effectively as a member of a multi-disciplinary team
Excellent self-organization skills with ability to envisage/design/implement organizational systems to improve efficiency and function of working teams
Preferred Education, Experience And Skills
Experience and familiarity with LabVantage LIMS
Experience with CMMS for equipment maintenance and management