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Senior Quality Control Analyst I

Apply Share Job ID 1670 Category Laboratory Operations Job Location Redwood City, California Posted Date 02/21/2020

Overview:

We are recruiting a Senior Quality Control (QC) Analyst to join our Reagent Manufacturing and Quality group. This is a unique opportunity to work with a talented team to support existing and new genomic assays aimed at transforming cancer patient care. The successful candidate will support the daily operation of QC inspection and quality testing of raw materials and in-house manufactured reagents and lead or participate in reagent manufacturing and QC development projects in a fast-paced and dynamic environment.

The Senior QC Analyst will demonstrate excellent attention to detail, effective written and verbal communication skills, the ability to multi-task and be flexible with tasks and schedules, and the ability to work both independently and in a team environment following applicable regulatory requirements and Exact Sciences Quality Management System.

The position will report to the Manager, Quality Control within the Operations organization.

RESPONSIBILITIES / DUTIES:
· Develop, perform, and troubleshoot inspection of incoming raw materials and in-house manufactured reagents
· Conduct and support the development of QC testing of materials and reagents using various analytical methods including but not limited to IE-HPLC, UV Spectrophotometry, and Enzyme Activity Assays
· Partner with Service Engineer and Finance for Vendor Services on contract renewals, annual instrument Preventive Maintenance, calibrations, and repairs
· Document, interpret data, and trend results per SOPs. Review data for quality, consistency, and accuracy per Exact Sciences quality requirements
· Ensure laboratory supplies and required inventory of reagents and equipment spare parts are maintained
· Lead or participate in a cross-functional team to investigate reagent and consumable quality issue and implement corrective actions
· Identify and troubleshoot equipment issues; act as SME for troubleshooting HPLC instrument-related issues
· Author and review analytical test method SOPs, instrument procedures, and work instructions
· Partner with Biostatistician to design and conduct new or updated reagent, analytical test method, software and instrument validation
· Provide support to reagent manufacturing when needed
· Train laboratory staff in existing and/or new processes
· Partner with Exact Sciences Quality Assurance group to ensure consistent compliance with applicable federal, state, and local regulations and quality-related best practices in development, validation, use, and documentation of analytical and functional test methods for reagent lot qualification, stability studies, and related activities
· Represent Reagent Manufacturing and Quality group in cross-functional project teams when needed
· Lead cross-functional project team to facilitate project execution plan under change control, including but not limited to managing timeline, tasks, and resources to achieve the targeted goals

QUALIFICATIONS:

· B.S. Degree in biochemistry, analytical chemistry, chemical engineering, or related discipline with -a minimum of 6 years of relevant experience in industry or CLIA laboratory setting
· QC analyst experience in a regulated environment
· Working knowledge with various analytical techniques including HPLC, pH, Conductivity, and UV SpectrophotometryAbility to the author and revise SOPs
· Ability to handle multiple tasks concurrently and in a timely fashion
· Ability to work independently with minimal supervision to complete tasks in resourceful and effective approaches
· Ability to act as a project leader to work with cross-functional teams to test and validate new reagents and consumables, and conduct stability studies of reagents
· Detail-oriented, thorough, and good communication skills with peers and across functional groups
· Proficiency in basic word processing and spreadsheet applications
· Willingness to be flexible and adapt to changing priorities
· Deep understanding and strong skill set for HPLC assay; experience in development of analytical methods for oligonucleotide testing is strongly desired
· Chromeleon CDS, SoftMax Pro, JMP software skills are desired
· Hands-on experience in reagent manufacturing a plus
· Experience with supporting the development of In-vitro Diagnostic Products under ISO13485 requirements is desired
· Project management skills are strongly desired
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If you want to be part of a team that prides itself in teamwork and developing cutting-edge technology at Genomic Health, apply today!