Scientist - Laboratory Systems and Operations
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Scientist – Laboratory Systems and Operations
This position is responsible for the oversight of laboratory systems, operations, data review, equipment maintenance, and validations at the Pharmaceutical Sciences Laboratories in Irvine facility.
Responsible for the maintenance and calibration activities for equipment and instrumentation at the R&D laboratories. Ensures that routine calibration and maintenance work orders are scheduled, issued, and completed within the scheduled due date. Coordinates, schedules, and oversees calibration and maintenance services performed onsite by subcontractors. Schedules emergency repair and maintenance activities requested through the service request system.
Represent department on CSV Validation project teams, technology transfer teams, launch teams, special task forces, etc. Update department manager on critical timelines and milestones. Provide input to manager for the determination of department commitments, resource needs and priorities to support project timelines. Provide technical support to development projects.
Actively participate in the evaluation, modification, and validation of new versions of the LIMS, Chromatography Data System, data management system, and electronic notebook systems. Interact closely with R&D IT, RDQA and external user groups or consultants to communicate issues and/or requirements and propose modifications to improve or enhance capabilities. Train personnel on the use of the system to ensure data integrity.
Works directly with managers to maintain the integrity of the Laboratory Information Management System (LIMS) and Empower Chromatography Systems. Initialize new research stability lots in a timely, efficient, and accurate manner. Verify, correct, and review data; update and review LIMS tables, such as protocols and specifications. Perform requested searches with the LIMS in a timely, efficient, and accurate manner. Write and update system requirement documents, validation protocols and reports, user manuals and SOPs.
Develop and maintain a working knowledge and understanding of test requirements for stability, clinical, and toxicological studies and a wide range of validated analytical procedures and analytical instrumentation.
Main Areas of Responsibilities
- Provides GMP oversight of technical data to ensure that protocols, memos, reports, or analytical methods accurately reflect the data reported in the laboratory notebooks, comply with department SOPs and protocol requirements and adhere to ICH guidelines.
- Maintains the integrity of the Laboratory Information Management System (LIMS). Initialize new research stability lots and verify correct LIMS configuration for study design.
- Ensures that routine calibration and maintenance activities are scheduled and completed within the due date.
- Manages CSV instrument HAR validations and authors documents including system risk assessment, validation plan, qualification protocols, user acceptance test scripts, validation summary reports.
- Supports change control activities associated with processes and equipment validations.
- Review and evaluate laboratory results generated by Analytical Department to ensure that data are accurate, reliable and all method/SOP requirements have been met.
- Provide quality oversight of technical data to ensure that protocols, memos, reports, and analytical methods accurately reflect the data reported in the laboratory notebooks, comply with department SOPs and protocol requirements and adhere to ICH guidelines.
- Assists the department in preparing for GMP inspections. Write pertinent SOPs and recommend modifications to existing SOPs to meet cGLP/cGMP/cGXP requirements.
- Performs all assigned duties according to departmental SOP’s and cGMP’s.
- Remain current on proper procedures by reviewing current, revised, and new SOP’s relating to the job and to the department.
- Complete and remain current with all required cGMP and safety training.
- Perform other duties as assigned.
- A 4 year college education (B.S.) in chemistry or related field and 6 or more years related industry experience in a pharmaceutical analysis or stability testing laboratory. Must have a thorough working knowledge of a wide range of analytical methods (i.e. HPLC, GC, spectroscopy, etc.). Experience with and an understanding of cGMPs/cGLPs is necessary.
- Excellent scientific approach and organization skills. Proven problem solving skills must be demonstrated.
- Possesses excellent communication (oral and written) and interpersonal skills.
- Ability to establish and maintain effective relationships with management, co-workers and customers and work well in a team environment.
- Self-motivated and demonstrated willingness to take on new approaches/technologies and additional responsibilities.
- Articulates ideas in a clear, concise manner. Actively listens to and encourages input before taking action.
- Consistently delivers on commitments and responds to customers’ needs in a timely and courteous manner.
- Key Leadership Competencies:
- Builds strong relationships with peers and cross functionally with partners outside of the immediate team to enable higher performance
- Learns fast, grasps the "essence" and can change course quickly where indicated
- Raises the bar and is never satisfied with the status quo
- Creates a learning environment, open to suggestions and experimentation to drive the science in the field of interest
- Embraces the ideas of others, nurtures innovation and manages innovation to reality
Significant Work Activities
Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)
Job Level Code
Equal Employment Opportunity
At AbbVie, we value bringing together individuals from diverse backgrounds to develop new and innovative solutions for patients. As an equal opportunity employer we do not discriminate on the basis of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information gender identity or expression, sexual orientation, marital status, protected veteran status, or any other legally protected characteristic.