Job Description :

Representative responsibilities will include management of laboratory scientific software for analytical labs. Computer systems validation (CSV) experience is required. Experience authoring and executing CSV software validation scripts required. Experience authoring SOPs for (1) Software System Use and (2) Software system administration required. Experience with managing and integrating the following software with other enterprise levels systems is required.

• Administer, configure, and maintain the Lab system to meet the laboratory’s needs, including system updates, user management, and ensuring data integrity and security.

• Develop and maintain integrations between the Lab system and other laboratory instruments, systems, and databases to facilitate secure data exchange and workflow automation.

• Provide technical support to lab staff, resolving issues related to LIMS and associated systems promptly. Train users on new features and best practices.

• Standalone Equipment software: QX Manager, Compass for Simple Western [BioTechne Jess], 32 Karat [Sciex PA800 ], Softmax Pro [Molecular Devices plate readers], PLA for bioassays [Steggman System]

• CDS (chromatography database systems) such as Chromeleon and/or Empower.

• LIMS SME and Administrator: Labware LIMS with LIMS Basic coding experience a plus

• Statistical Program validation and administration—experience with JMP a plus

• Experience setting up procedural and physical controls for software that may not meet certain compliance standards.

• Experience authoring CSV related documents such as Gap Analyses, URS, risk assessments, etc.

• May assist in authoring and maintaining a compliance checklist to guide the assessment process by cross-checking the company's performance against legal standards and identifying organizational gaps, weak points, and risks where adherence to rules should be tightened. May be involved in regular software audits to ensure compliance is maintained.

• Excel spreadsheet creation, use, administration and validation in a GMP setting experience is a plus.

• Maintain laboratory computerized system compliance status throughout the system lifecycle and assist in software deviation investigations.

• Manage external software consulting partners, coordinate training activities,

Position Requirements (Required and/or Preferred Skills, Experience and Education):

• Minimum of 3-8 years of prior experience in lab software ownership and administration in a regulated pharmaceutical industry

• Good communication/inter-personal skills in working with business owners and contractors/consultants

• Labware LIMS administration or management required. “LIMS Basic” coding a plus, but must be willing to learn.

• Have full understanding in FDA regulations in equipment and computerized systems, especially 21CFR Part 11. Maintain robust IT security measures to protect sensitive data.

• Entrepreneurial spirit, with strong willingness to take on new challenges required to bring novel medicines to the clinic.

• Strict adherence to environmental, health, and safety guidelines.

Job Types: Full-time, Contract

Pay: $50.00 - $60.00 per hour

Expected hours: 40 per week

Schedule:

• 8 hour shift

Experience:

• Labware LIMS: 1 year (Required)
• Computer systems validation (CSV): 1 year (Required)

Ability to Relocate:

• San Diego, CA: Relocate before starting work (Required)

Work Location: In person