02 Nov
Quality Control Specialist
California, Santaclara , 95050 Santaclara USA

JOB SUMMARY The Senior Scientist - Reagent Manufacturing Quality will be an integral part of a quality team that performs raw material, finished goods sub-assembly qualification testing and data-analysis for reagents for a variety of sequencing products. The individual will be responsible for review, generation and sign-off of quality documentation. The ideal candidate will be responsible for interfacing with highly complex systems and controls in an ISO13485 and soon to be cGMP manufacturing environment. The individual will maintain areas in high state of inspection preparedness by maintaining equipment, records and laboratory environment in order to comply with regulatory requirements utilizing current regulations and Standard Operating Procedures (SOP). Responsibilities Perform inspection and testing of raw materials and in-process finished goods subassemblies right first time in a compliant manner. Conduct data analysis of raw material and in-process finished goods subassemblies test results. Review QC records and generate Certificate of Analysis for finished products. Formulate reagents with high complexity for raw material testing. Document test results, complete batch records, document observations and generate reports for raw material and in-process finished goods subassembly qualification testing Responsible for generating compliant QC documentation as part of the Device Master Record required for releasing items into inventory from the raw material to the final kit assembly level. Maintain records and QC laboratory environment to comply with cGMP, SOP and regulatory requirements. Serve as a contact for other departments regarding QC related activities, quality issues, nonconformance investigations, and root cause analysis. Provide input for brainstorming activities, support approaches for problem-solving, trouble-shooting and data analysis related to QC failures. Provide training to quality control team members. Assist in reagent and lab supply inventory management in order to support multiple QC laboratories. Coordinate/plan weekly QC activities with team in order to meet production demands. Review purchase orders for raw materials Assist in the development and implementation of raw material testing processes, physical quality specification tests and documentation Assist in performing routine maintenance of laboratory equipment Assist in performing, reviewing and/or generating validations for QC processes and laboratory equipment Assist in identifying quality gaps and support continuous improvement / operational excellence initiatives. Assist in process monitoring and trending across all shifts. Collect, interpret and communicate process metrics; utilize metrics to recommend improvements. Support 5S efforts to streamline overall operations and improve efficiency Must demonstrate a comprehensive understanding of both general and specific aspects of multiple manufacturing departments. Troubleshoot and investigate complex problems, work with others to implement solutions. Follow established safety and environmental guidelines and procedures for all work performed. Immediately report safety and environmental incidents including injuries, illnesses, near misses, and safety suggestions. Foster a positive safety culture in which no one gets hurt. Assist in regular laboratory environment monitoring tests Assist in transferring processes from development to QC Assist in testing raw materials for reliability and stability Assist in reagent manufacturing activities unrelated to QC activities Other duties as assigned by management. Knowledge, Skill or Ability Req Pref ProficiencyExcellent oral and written communication skills demonstrated by communicating with other functions and management regarding resolving testing, investigations and theory. Ability to lead department and/or cross functional meetings or projects.Strong data-analysis skills, with clear demonstrated understanding of analytical, troubleshooting, and problem solving skills. Hands on experience in a laboratory Accurate and precise manual pipetting and measuring techniques Experience working in a GLP, cGMP or ISO regulated environment is preferred, but not required Experience with 5S and Lean techniques is preferred, but not required Proven math skills Experience with Excel and proficient understanding of Excel statistical formulas is preferred, but not required Demonstrated attention to detail and strong organizational skills Proven ability to meet deadlines and work under aggressive timelines Demonstrated ability to work effectively in a team environment Experience working with Tecan instruments or liquid handling systems is preferred, but not required Experience with handling corrosive and biohazardous reagents is preferred, but not required Other: Work is performed in a laboratory environment

EOE Statement: Specialist Staffing Group is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.

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