This position is responsible for the oversight of laboratory systems, operations, data review, equipment qualification, and validations at the Analytical Laboratories in Irvine facility.
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.
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.
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.
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.
- 4 year college education (B.S.) in biology, biochemistry, 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.
Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law:
The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future.
We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.
This job is eligible to participate in our short-term incentive programs.
Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company’s sole and absolute discretion, consistent with applicable law.
AbbVie is committed to operating with integrity, driving innovation, transforming lives, serving our community, and embracing diversity and inclusion. It is AbbVie’s policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because 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, status as a protected veteran, or any other legally protected group status.