Reference: 298 03/05/2022 17:01:54

Senior Quality Specialist.

Newark, San Francisco Bay Area - United States Competitive

As a Senior Quality Specialist/Quality Assurance II, you will be working as part of the Quality Assurance team, using your training and skills towards the implementation, maintenance, and continuous improvement of the Quality Management System and ensuring compliance with international standards and regulations, within an established, market-leading biotechnology company.

In this role, you will be responsible for validation, supplier management, change control and will support other quality system processes. This is a highly visible, hands-on position that must be able to work independently and as part of a team.

Location: Newark, San Francisco Bay Area, CA. (Onsite).

Responsibiltiies

  • Manage supplier quality, including supplier qualification, quality agreements, maintain approved supplier list (ASL), etc.

  • Manage overall validation program, including equipment, computerized systems, processes and test methods. Collaborate with owners to develop and execute protocols.

  • Manage change control process.

  • Provide training in ISO requirements and quality procedures.

  • Assist in internal and external audits, including customer audits.

  • Work with R&D and custom product management for design control implementation for new and custom products, including defining user needs, risk management, verification and validation, design review requirements, etc.

  • Support nonconformance, deviation, complaint, and CAPA systems.  Work with investigation owners to assess root cause, corrections, corrective actions, preventative actions and effectiveness. 

  • Support review and approval of batch records as needed.

  • Support document and record control as needed.

  • Report and analyze monthly quality system metrics from excel logs and electronic Quality Management System.

  • Lead quality improvement projects, including planning, communicating, developing action plans, and providing regular project updates.

  • Assure compliance with all in-house or external specifications to standards.

  • Identify quality issues/discrepancies and effectively resolve discrepancies within the organization. 

Requirements

  • BS Degree in scientific discipline.

  • Quality professional with a minimum of 3 years in a quality role in a life science industry. 

  • Requires knowledge of ISO 9001, ISO 13485, 21 CFR 820, or 21 CFR 211.

  • Auditing experience in quality assurance requirements.

  • Knowledge of equipment, processes, test method validations; or computer system validations a plus.

  • Proficient in Microsoft Office; experience with NetSuite ERP and MasterControl a plus.

  • Strong verbal and written communication skills.

  • Strong organizational and problem solving skills.

 

If you are interested in learning more, APPLY BELOW, or get in touch at @: joe.bell@lifesci-cm.com

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Joe Bell
Joe Bell
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