Role: Lab Technician - III
Type: 5 Months +
Location: Foster City, CA.
Investigator (EET) – Analtical Operations
Specific Responsibilities and skills and skills for position
• Writing Production, Maintenance, Engineering, & Quality Control Investigations
• Conduct investigations thoroughly to identify all impacts to patients, product quality, validated state, and regulatory compliance
• Conduct root cause analysis to identify all contributing and potentially contributing factors for which led to the deviation
• Perform risk analysis as needed to determine likelihood and severity of recurrence
• Address impact to systems, processes, product, and any regulatory requirements
• Write External Event Tracker (EET) reports, deviation reports (DV), laboratory event (LE) summary reports, Corrective Action/Preventive Action (CAPA) summary reports, effectiveness check (EC) Identify and develop meaningful and effective CAPAs
• Monitor completion of EETs, DVs, LEs, CAPAs, ECs, and CMs
• Prioritize and organize EETs, DVs, LEs, CAPAs, ECs, and CMs to ensure timely completion
• Must be able to communicate effectively and appropriately
• Understanding of FDA regulations and GxP
• Must be able to conduct interviews and properly document interviews as appropriate to laboratory investigations and deviations
• Perform all technical writing with grammatically correctness, conciseness, accuracy, and completeness with timely completion to meet appropriate deadlines
• Working knowledge and proficiency with Microsoft Office Software
• All of the previous level plus:
• Troubleshoot instrumentation/test methods
• Lead/coordinate QC and cross functional projects with limited direction
• Leads the training of QC staff to support appropriate implementations of CAPAs
• Perform metrics as appropriate for laboratory investigations, deviations, and CAPA
Knowledge, Experience and Skills
• 10+ years of experience with BS degree in a relevant scientific discipline or 8+ years of experience with MS degree in relevant scientific discipline
• 3 – 5 years of experience in technical writing for deviations and investigations
• Strong interpersonal skills that allow for effective communication across functional areas and senior leaders
Clinical Lab Technician (New-Grads )
San Carlos, CA - lab technician, calibration, lab, qc, laboratory,...
R&D Lab Technician
Hayward, CA - lab technician, lab, calibration, chemistry,...
Lab Technician I
Mountain View, CA - lab, lab technician, bio, electrical, laboratory,...
Lab Technician I
Mountain View, CA - lab technician, biology, lab, optical, laboratory,...
Cath Lab - RN
Burlingame, CA - cath, cath lab, lab, lab technician, technologist,...
Analytical Operations- CAPA
San Mateo, CA - qc, fda, laboratory, event, investigations,...
Investigator (EET) Analytical Operations
San Mateo, CA - qc, investigator, laboratory, investigations, fda,...