QA Specialist - 17483

QA Specialist- Simply Biotech

OVERVIEW

Are you looking for a new career opportunity with an exciting biotech company?! Then we've got the right team for you! In this role, you're responsible for the duties listed below.

Immediate opening for a QA Specialist, in Gardena, CA who possesses:

• Bachelor's degree
• 5 years of experience within pharmaceutical, biotech, medical device, nutraceutical, or chemical manufacturing
• Experience with deviations, investigations, customer complaints, supplier issues
• FDA audit, or regulatory audit, or OSHA experience

Full Job Description:

The selected candidate will be responsible for:

• Assist customers with various quality documentation requests regarding Company's Quality Management System.
• Assist the Company's Sales team by providing quality-related documentation as requested.
• Assist in assuring that the company's operates in accordance to current Good Manufacturing Practices & regulations and in compliance to ISO 9001:2015 Quality standards.
• Complete Customer Quality Surveys & Questionnaires
• Coordinate Quality / Technical data requests: such as Customer Spec Sheets, or Certificates of Origin, Stability Data, GMP Certifications, etc.
• Perform Internal Quality Audits
• Assist in hosting Customer Quality System Audits and or Regulatory Inspections
• Qualification Program
• Evaluating supplier self-audit questionnaire
• Performing site quality system audits
• Tracking supplier performance
• Responsible for Supplier Corrective Action Request (SCAR)
• Establishment of Quality Agreements/Clauses
• Supply chain resolution
• Maintain and monitor CofA challenge
• Maintain Customer Change Control Program and Notification Support to affected parties
• Assist with quality investigations

The selected candidate will also possess:

• Knowledge of Quality System requirements of ISO 9001:2015, current Good Manufacturing Practices 21 CFR 210& 211, IPEC PQG, and ICH Q7/A
• Must have basic computer literacy including familiarity of programs such as Word, Excel and Pagemaker, Filemaker
• Lean process improvement and Six Sigma, 5 S experience and background preferred

Salary Range: $65k-$95k/yr
For immediate and confidential consideration, please email your resume to ahall@simplybiotech.com or call 469.895.5514
More information can be found at www.simplybiotech.com