Role: Senior Scientist/Senior QC Instrument Scientist
Duration: 6 Months (potential to extension or conversion)
Location: San Diego, CA 92121 – Onsite
- Day to Day Responsibilities: Lead various analytical instruments qualifications with extensive experience on 21 CFR Part 11 compliance requirements.
- Act as owner of instrument asset from analytical team to collaborate with internal partners on appropriate instrumentation lifecycle management.
- Oversee instruments in the lab, which include calibration, PM, troubleshooting, new instrument induction and qualification implementation and documentation.
- Have a fundamental understanding of software 21 CFR Part 11 server IT requirements and hardware/software documentation requirements for QC purposes. Have hands-on experience to draft user requirements specification, performance qualification protocol and hardware/software validation protocol and report.
- Act as primary point of contact with EHS and QA teams to ensure lab readiness for walkthroughs and audits.
- Lead analytical lab relocation activities to ensure the instruments are handled and qualified properly pre and post move
- What makes you successful: Must be proficient with both analytical instrument hardware and software qualification requirements and activities for instruments like GPC-MALS, HPLC-ELSD, LC-MS, GC-FID/MS, FTIR etc.
- Extensive hands-on experience with analytical instrumentation operation, troubleshooting, maintenance and repair.
- Effective technical writing skills, including ability to write protocols, OOT investigations, and other technical reports and documents.
- Excellent interpersonal and communication skills with demonstrated ability to coordinate and prioritize activities to meet objectives on time and with a high level of quality.
- Extensive hands-on experience with QC LIMS implementation to connect analytical instruments with report exporting as well as centralized data management.
- Position Summary
- A. Equipment Lifecycle Management Lead new equipment onboarding and qualification (IQ/OQ/PQ coordination)
- Manage instrument maintenance programs, including:
- Preventive maintenance scheduling
- Service contract management
- Vendor coordination
- Ensure instruments remain in a state of control and compliance
- B. cGMP Compliance & Audit Readiness Maintain inspection readiness of the laboratory at all times
- Support internal and external audits (FDA, ISO, client audits)
- Ensure adherence to:
- SOPs
- Data integrity requirements
- Documentation practices
- C. Software & Data Systems Qualification Oversee laboratory software validation/qualification (e.g., CDS, LIMS, instrument software)
- Ensure compliance with data integrity principles
- Support lifecycle management of computerized systems
- D. Laboratory Relocation & Infrastructure Projects Support and coordinate lab relocation activities, including:
- Equipment move planning and qualification
- Utility and layout readiness
- Risk mitigation during transition
- Assist in new lab setup and infrastructure readiness
- E. Inventory & Asset Management Oversee laboratory inventory systems, including:
- Chemicals, consumables, and standards
- Asset tracking and calibration schedules
- Ensure availability of critical materials while controlling costs
Education Requirement
- Typically requires a Bachelor's degree in a technical discipline
Work Experience
- 5-8 years of related experience
Applicant Notices & Disclaimers
- For information on benefits, equal opportunity employment, and location-specific applicant notices, click here
At SPECTRAFORCE, we are committed to maintaining a workplace that ensures fair compensation and wage transparency in adherence with all applicable state and local laws.This position's pay range is $60.00/hr - $65.00/hr.
Senior Scientist in san diego at Unknown Company
This position is listed as contract and onsite.