Position Summary:This position will be responsible for maintaining LabVantage LIMS at Bionova Scientific, Fremont in support of Quality and Manufacturing. This position will also assist with implementing enhancements or new systems, and integration of equipment software with LabVantage. LabVantage LIMS contains the following functionalities: sample management, stability sample tracking system, reagent management, electronic lab notebooks. This may include identifying and implementing business process improvements that will drive Bionova Scientific's business performance and Quality innovation.
This position will provide a high level of independent judgment and discretion in the timely identification, investigation, and resolution of issues impacting the Quality Control department related to LIMS. Quality Control responsibilities include ensuring adherence to cGMP requirements, proper change control, corrective action and preventative action plans, impact assessments for changes to equipment and processes, risk management, ensure documentation and investigations meet Bionova Scientific and regulatory standards. Assists in implementing continuous improvement efforts as it relates to Quality Control activities.
Essential Duties and Responsibilities:- Responsible for and maintaining LIMS systems (QC, Environmental Monitoring, Raw Materials and Stability) at Bionova Scientific Fremont.
- May assist with the implementation of enhancements or new systems.
- May be a delegate for the process during internal/corporate client audits and health authority inspections.
- Responsible for establishing the stability sample Buildout for the system.
- Responsible for establishing and maintaining ELN worksheets.
- Responsible for training site staff involved with the LIMS systems.
- May be the key point of contact when working with internal partners (E&T, Validation, QA) and external partners (vendors, clients).
- Assist and be a delegate for QC SME for Data Integrity initiatives, continuous improvements, and related activities.
- Assist in cross-functional investigations or assessments in support of change controls, CAPA/investigations or other compliance activities as it relates to LIMS.
- Manage moderate to complex projects.
- Occasionally may assist in validation activities as it relates to LIMS; may include development and validation of interfaces or new reports.
- Participate in inspection preparation activities as needed. Able to present and defend GMP documentation and practices in an internal and external audit as needed.
Working Conditions:This position is required to work in an office setting.
Qualifications:- Bachelor's Degree from an accredited institution in Chemistry, or Biology (or closely related degree).
- Requires 2 years of quality pharmaceutical or medical device experience.
- Minimum of 2 years LIMS experience (Development, Validation, Maintenance)
- Strong independent judgment and decision-making abilities and strong conflict resolution required.
- Knowledge and experience with implementing 21 CFR Part 11 and Annex 11 compliant instruments and software.
- Good working knowledge of relevant regulations and guidance required and act as a resource for colleagues. Including but not limited to 21 CFR Part 11 and Annex 11.
- Working knowledge of validation of new computer systems, changes to existing computer systems, and/or decommissioning computer systems; includes experience with system life cycle documents.
- Participates in Data Integrity and continuous improvement initiatives.
- Participates or experience leading projects with history of achieving results.
- Demonstrates initiative; ability to undertake additional responsibilities and respond to situation as they arise with little or no supervision.
- Proficiency in Microsoft Office including Word, Excel, PowerPoint.
- Ability to make independent sound decisions and manage priorities in alignment with department and site drivers
