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Lab Technician - III

Latitude 36 INC
Foster City, California, United States
December 01, 2016

Role: Lab Technician - III

Type: 5 Months +

Location: Foster City, CA.

Job Description

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

Essential Functions

• 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