- Ensures LIMS activities are conducted in compliance with current Good Manufacturing Practices (cGMP), all data integrity standards are maintained and issues are mitigated in a timely manner. Communicates to Quality Assurance and Quality Control leadership when a quality issue with LIMS is identified.
- Subject matter expert (SME) for LIMS during audits, and will ensure the audit readiness of the following: qualification documentation, user lists and privileges, and procedures,
- Work with other LIMS Specialists, vendor and LIMS support to increase working knowledge of LIMS to provide better support to LIMS users
- Recommends and/or implements system enhancements as needed to make best use of the LIMS application and improve the end user experience through greater efficiencies within the system, interfaces with other equipment/applications, and/or electronic solutions to manual processes.
- Trains subject matter experts, trainers and end users on the System and changes to the System as required
- Provides timely response to user needs to include managing user accounts, troubleshooting applications, programming new report templates, and maintaining change records in accordance with version control procedures.
- Provides LIMS training, technical support, problem reporting and resolution(s) to Quality Control laboratory, QA, and Manufacturing staff
- Develops and implement new functionality in LIMS and LIMS instrument interfacing as required by evolving business needs.
- Collaborate with IT and QA Validation Departments to facilitate validation activities; develop and/or execute test scripts as required
- Write and execute test scripts to validate LIMS master data and reports
- Create change control documentation including any required validation paperwork
- Coordinate with other IT and Business Unit team members to implement updates or changes in an efficient manner.
- Update and seek feedback on the LIMS system performance by holding routine communication with LIMS' internal laboratory users. Primary point of contact with Laboratory Leadership: Supervisors, Managers, and/or Director.
Minimum Education Requirements
- B.S. degree in Computer Sciences, Information Technology, Biology, Microbiology, Biochemistry or other relevant scientific discipline (with hands-on laboratory experience preferred)
- 8+ years of experience working in an administrative capacity with LIMS in a FDA regulated industry (drugs/biologics).
- LabWare LIMS, version 6 (or greater) experience highly preferred
- Thorough knowledge of cGMP/ICH/FDA regulations with 21 CFR Part11 and GAMP knowledge
- Experience with laboratory instrumentation, software and their interfacing is highly desired
- Experience with change control and software validation required
- Excellent oral and written communication skills
- 8+ years of working experience in an administrative capacity with LIMS, including system upgrades.
Desired Skills, Experience and Abilities:
- Quality Regulations in Pharmaceutical environment (EMEA, FDA, USDA, EPA, IVDC, others) and technical guides (GAMP, PIC/S)
- Strong experience in Quality Control Workflows, Labware LIMS, Computerized Systems Validation
- Project Management skills in transverse and complex international environment
- Programming experience (VB, VBA, SQL, ASP and HTML)
- Autonomous, organized and rigorous
- Ability to partner with internal and external stakeholders
- Ability to communicate efficiently
- Excellent Analysis and synthesis skills
- Strong communication for both external and internal customers.
- Passion to provide excellent customer service.
- Ability to write reports and business correspondences.
- Ability to communicate succinctly and effectively to key stakeholders.
- Ability to listen and respond well to external customers, partners, and colleagues at all levels.
- Excellent time and project management skills as well as ability to meet deadlines.
- Solid analytical, logical thinking and problem-solving skills.
- Desire and willingness to troubleshoot issues, communicate procedural gaps and recommend improvements in partnership with IT.
FDBU works with technical data, technology and materials that are subject to U.S. export laws and regulations. This position will require access to technical data, technology and source code that is controlled under U.S. export laws and regulations, including but not limited to the International Traffic in Arms Regulations at 22 C.F.R. Parts 120 – 130 and Export Administration Regulations in 15 C.F.R. Part 730 – 774, as may be amended. To conform to these laws and regulations, applicants must be U.S. citizens, lawful permanent residents of the U.S., protected individuals as defined by 8 USC 1324(b)(a)(3) (i.e., asylees and refugees) or otherwise eligible for an export authorization from the U.S. Department of State or U.S. Department of Commerce. Offers of employment will be contingent on the Company’s ability to secure an export authorization. FDBU is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, protected veteran status, sexual orientation, gender identify or any other protected class.
FDBU is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, protected veteran status, sexual orientation, gender identify or any other protected class.