Supervisor, Quality Control Analytical
美国 - 加利福尼亚州 - 圣莫尼卡产品开发和运营正式员工职位描述
Gilead Sciences is looking to hire a Supervisor, Quality Control Analytical.
Job Responsibilities & Requirements include but are not limited to:
Leadership
Experience with leadership, people management, and project management
Demonstrated leadership and management skills, including establishing direction and goals, and building good work ethics for the team
A minimum of 3 years’ experience supervising/managing is preferred
Routine Testing Support
The ideal candidate is well versed in various analytical methods (flow cytometry, potency ELISA, qPCR/ddPCR) in a cell therapy environment to support QC data review & COA generation to support on-time patient/stability testing and release
Supervision of all QC Analytical laboratory scheduling and testing to meet timelines
Supervisor/Manager review of QC Data and Generation of CoAs for on-time product release
Complete routine review of QC test data and related documents for stability, reagent release, etc.
Monitor and trend QC data results
Management of QC Analytical training program
Maintaining Operations
Provide updates/escalations at daily and weekly site-specific and cross-site meetings Experience with method development/qualification, tech transfer, QC testing, and laboratory deviations/investigations
Conduct investigations regarding out of specifications (OOS) results and address/manage deviations related to analytical procedures
Review & approve laboratory deviations and lab investigations
Review & approve as SME site-specific and global SOPs and forms
Develop, revise and review SOPs, qualification/validation protocols and reports
Provides technical support for SOP & protocol writing & review.
Audits & Compliance
Working knowledge of quality systems and regulatory requirements (21 CRF Part 11/ 210/ 211) Knowledge of regulatory requirements for data integrity and practices. Audits & compliance
Knowledge of regulatory guidance and experience maintaining QC lab GMP compliance and audits
Monitor the GMP systems currently in place to ensure compliance with documented policies
Review proposed changes to systems, procedures, methods, and submissions to regulatory agencies, as appropriate
General
Experience with LIMS
Knowledge of CAR-T manufacturing, micro methods (e.g., sterility, endotoxin, and environmental monitoring), and equipment IQ/OQ/PQ/PV a plus
Proficient in MS Word, Excel, Power Point and other applications
Excellent interpersonal, verbal and written communication skills are essential in this collaborative work environment
Comfortable in a fast-paced environment with minimal direction and able to adjust workload and flexibility based upon changing priorities
Gather metric information for use in continuous improvement of areas of responsibility Other duties as assigned
Knowledge:
Experience with analytical methods (flow cytometry, potency ELISA, and ddPCR/qPCR) in a cell therapy environment to support QC testing, data reviews, & COA generation to support patient/stability testing and release
Experience with leadership, people management, and project management
Experience with method development/qualification, tech transfer, QC testing, and laboratory deviations/investigations
Knowledge of regulatory guidance and experience maintaining QC lab GMP compliance and audits
Specific Education & Experience Requirements:
5+ years of relevant experience and a BS or BA. OR
3+ years of relevant experience and a MS.
Prior management experience in pharmaceutical industry is preferred