職位描述
General Duties and responsibility
- Responsible for policies, procedures, and maintenance required to support all systems and applications owned and managed by GLSS
- Provide back up to GLSS Coordinator
Provide support for training when needed for new GLSS Coordinator
- Based on business need, may be assigned tasks at level above (GLSS Administrator I)
- Monitor and report performance metrics report notable variances to senior staff.
- Individual is responsible for maintaining his/her complete up-to-date training file. Individual is responsible for ensuring he/she is trained and training is documented prior to performing a task. Individual is accountable for any deficiencies found in his/her training file.
- Participate in team tasks related to planning, budgeting and cross CCLS management team issues
- Support a culture of continuous improvement, quality and productivity
- Provide a monthly report to the Manager.
- Other duties as assigned General Laboratory Support (GLS)
- Accountable for investigating GLS inquiries, issues and their root causes identification; resolves issues when possible.
- Responsible of General Laboratory Support requests completion in time
- Responsible of global/local communication with other department than Lab Operation such as but not limited to, Logistic, Procurement, Project Management and Quality Assurance to identify and improve lab efficiencies (including lab items consolidation, maintenance of lab equipment etc.)
- Responsible for completing professional organization membership renewals and accreditation for Directors (CQ holders).
- Responsible for gathering and drafting all related information for the CER’s documents by working with Finance, Procurement and GLSS Management
- Responsible for re-certification of all cross-departmental ancillary equipment calibration, maintenance and repair.
- Responsible for coordinating all local and global Proficiency Testing (PT) programs: ensures local departmental and global testing sites meet deadlines for proficiency survey responses; distributes survey samples to ensure timely return of data forms as required. Maintains up to date files for global PT program.
- Responsible for providing local/global PT metrics and quality reports for use in evaluating performance by department and testing site location.
- Responsible for working with PT agency contacts and Lab Directors to ensure annual subscriptions to PT programs are accurate; provides updates to subscriptions as required.
- Responsible for performing the entry of Laboratory data into Quality Control Summary Report Tool.
- Demonstrates expert knowledge in the area of regulatory compliance
Combinable Data (CD) duties and responsibility
Responsible of supporting Quality Controls (QC) Laboratory Monitoring tools configuration, set up and QC transmission in defined timelines
Responsible to perform CAP PT evaluation for the Laboratory Operation and manage Metrics
Responsible of supporting Global QC Reservation and Global Correlations activities by liaising with Combinable Data group globally. Assist with global internal and external communication with QC providers and Laboratory Global Heads
Laboratory Compliance Support
- Responsible of APAC instruments qualification planning
- Responsible of managing regulatory compliance activities linked to FDA 21CFRPart11 and ensure global understanding and implementation with lab operation and coworkers.
- Responsible of coordinating and ensuring compliance enhancement and changes are reflected in GLSS procedures in collaboration with Lab Management, Quality Assurance and Global Compliance Team.
- Demonstrates expert knowledge in the area of regulatory compliance
Education / Qualifications
Minimum Required:
- BS, MT (or equivalent) with one (1) or two (2) year(s) clinical laboratory experience,
- or BS, science (or equivalent) with two (2) years clinical laboratory experience,
- or an AS, MLT (or equivalent) with three (3) years clinical laboratory experience or a minimum of 6 to 9 months successful experience as Associate Technical Administrator or a minimum of one (1) year of successful Senior QC Administrator experience.
Experience
Minimum Required:
MT (Medical Technologist) -one or two years of experience
MLT( Medical Laboratory Technologist) -two years of experience
Strong planning, organizational, and problem solving skills.
Ability to multi-task
Ability to work Independently
Attention to detail
Preferred
Location: 浦東新區(qū)張江高科技園區(qū)李冰路151號(hào)3號(hào)樓
