AskBio Inc
Analytical Lab Operations Specialist II
Durham, NC · Mid
Sponsorship not specifiedDetected 26 days ago
Inventory ManagementRecruitingGMPCRISPRResearchCommunicationWriting
About the role
- The Analytical Lab Operations Specialist II will be responsible for supporting lab operations within the Quality Control and Analytical Development laboratories.
- This position is based on site in Durham, NC and will report to the Lab Operations Manager.
- Author new SOPs and revise existing SOPs as needed
Responsibilities
- Support management and execution of Operational and Capital Expenditure budgets for Quality Control and Analytical Development Labs
- Own, initiate, and author deviations, CAPAs, and Change Controls related to all GMP operations and processes
- Support continuous improvement of lab operations procedures by independently identifying process gaps
- Pioneering science to create transformative molecular medicines.
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.)
- Ability to handle multiple projects/teams simultaneously
- Ability to work independently in a fast-paced, highly interactive environment with minimal supervision
- Experience and familiarity with LabVantage LIMS
- Experience with CMMS for equipment maintenance and management
- All agencies must have a prior executed service agreement with AskBio prior to any search engagement.
Company info
- Lead innovative science and drive clinical outcomes to transform people's lives.
- Be a Pioneer. We are not afraid of the impossible and to innovate to make gene therapies accessible to those in need.
- Cultivate Collaboration. Strive to be the best teammate, actively listen, openly communicate, and embrace diverse points of view.
- Embrace Responsibility. We are humbled by the enormity of our mission. We hold a relentless commitment to advance science and clinical outcomes for our patients, families, and caregivers.
- Raise the Bar. Continuously drive improvements and efficiencies. Seek and provide constructive feedback. Have a bias for learning and action.
- Act with Uncompromising Integrity. Be honest, transparent, and committed to doing what's right in every situation. Make clear commitments and follow through.
- 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 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
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