Sr. Analytical Scientist (QC/Instruments Calibration/Troubleshoot/21 CFR/HPLC/Qualification)
russell tobinSan Diego, CA
$60–$76/hrAPPLY NOW (opens in a new tab)
Sr. Analytical Scientist (QC/Instruments Calibration/Troubleshoot/21 CFR/HPLC/Qualification)
Occupations
Quality Control AnalystsPrecision Instrument and Equipment Repairers, All OtherCalibration Technologists and TechniciansIndustries
Analytical Laboratory Instrument ManufacturingTesting Laboratories and ServicesIn-Vitro Diagnostic Substance Manufacturing$60–$76/hr
APPLY NOW (opens in a new tab)About the role
Senior Analytical Scientist – QC Instruments Specialist (21 CFR Part 11/HPLC/GC-MS/GPC-MALS /Instrument Qualification) Russell Tobin is seeking an experienced Senior Analytical Scientist – QC Instruments Specialist to lead analytical instrument qualification, laboratory compliance, and instrumentation lifecycle management within a regulated analytical laboratory in San Diego, CA. This role focuses on instrument hardware and software qualification, 21 CFR Part 11 compliance, laboratory relocation, and ensuring the laboratory remains inspection-ready and compliant with cGMP requirements.
Responsibilities:
- Lead qualification activities for analytical instruments, including HPLC, GC-FID/MS, GPC-MALS, FTIR, Instron, and other laboratory equipment.· Serve as the analytical team's instrument asset owner, coordinating with internal stakeholders on instrumentation lifecycle management.· Oversee instrument calibration, preventive maintenance (PM), troubleshooting, repair, new instrument induction, and qualification activities.· Ensure compliance with 21 CFR Part 11 requirements, including software, server, IT infrastructure, and hardware/software documentation requirements.· Draft and execute User Requirements Specifications (URS), Performance Qualification (PQ) protocols, hardware/software validation protocols, and qualification reports.· Lead analytical laboratory relocation activities, ensuring instruments are properly handled, assessed, and qualified before and after relocation.· Support instrument lifecycle management, out-of-trend (OOT) investigations, and technical documentation.· Lead QC LIMS implementation activities to enable analytical instrument connectivity, automated report exporting, and centralized data management.· Prepare technical reports, investigation documents, qualification protocols, and other compliance-related documentation.
Requirements:
- Bachelor's degree in a technical discipline or related field.· 5–8 years of relevant industry experience.· Extensive hands-on experience with analytical instrument hardware and software qualification.· Strong experience with 21 CFR Part 11 compliance requirements.· Hands-on experience leading analytical laboratory relocation activities, including instrument qualification before and after the move.· Proficiency with analytical instruments such as HPLC, GC-FID/MS, GPC-MALS, FTIR, Instron, LC-MS, and HPLC-ELSD.· Extensive experience operating, troubleshooting, maintaining, and repairing analytical instrumentation.· Experience drafting URS documents, qualification protocols, validation protocols, and technical reports.· Strong understanding of instrument lifecycle management, calibration, preventive maintenance, and cGMP compliance.· Excellent technical writing, communication, organizational, and cross-functional coordination skills.
Preferred Qualifications:
- Hands-on experience with QC LIMS implementation and analytical instrument integration.· Experience with instrument lifecycle management and OOT investigations.· Experience preparing technical documentation, including protocols, reports, and traceability documents.
Additional Details: Location model: 100% On-site — San Diego, CA
Schedule: 1st Shift — Monday–Friday, 8:30 AM–5:00 PM
Position Type: 6-month contract with potential to extend or convert
Pay range approved: $60–$76/hr, depending on experience. APPLY NOW!Russell Tobin is a professional recruitment and staffing advisory firm that connects job seekers and employers across various industries. We are a staffing arm of Pride Global. Affiliates include Russell Tobin, Pride Health, Pride Now and Pride One. For workers in the United States, PrideGlobal and it's affiliates offers eligible employee’s comprehensive healthcare coverage (medical, dental, and vision plans), supplemental coverage (accident insurance, critical illness insurance and hospital indemnity), 401(k)-retirement savings, life & disability insurance, an employee assistance program, legal support, pet insurance and employee discounts with preferred vendors.
Equal Employment Opportunity:
PrideGlobal and it's affiliates are an equal opportunity employer. We do not discriminate on the basis of the race, religious creed, color, national origin, ancestry, physical disability, mental disability, reproductive health decision making, medical condition, genetic information, marital status, sex, gender, gender identity, gender expression, age, sexual orientation, veteran or military status, or any other characteristic protected by applicable federal, state, or local law.
Fair Chance Employment:
PrideGlobal and it's affiliates are a Fair Chance employer. We consider all qualified applicants, including those with criminal histories, in a manner consistent with applicable state and local Fair Chance laws and ordinances, including, the California Fair Chance Act and all applicable local Fair Chance ordinances.
Accommodations:
We are committed to providing reasonable accommodations to applicants and employees with disabilities. If you require a reasonable accommodation to participate in the application or interview process, or to perform the essential functions of this role, please contact us. Only applicable for San Francisco Candidates: Under the San Francisco Lactation in the Workplace Ordinance, we will provide written notice of lactation accommodation rights, and this notice will automatically be given upon hiring, any inquiry of parental leave or lactation accommodation. Only applicable for Kentucky positions: For this type of employment, state law requires a criminal record check as a condition of employment. This applies to direct care staff (Examples: RN, LPN, Nurse Aides, Therapists) referred to Kentucky nursing facilities, assisted living communities, or long-term care facilities, in accordance with KRS 216.793.
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JOB OVERVIEW
Salary
$60–$76/hr
Experience level
Lead
Location
San Diego, CA
Occupation
Quality Control Analysts
Industry
Analytical Laboratory Instrument Manufacturing
Posted
today
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