QA Specialist - 17483
- Expired: over a month ago. Applications are no longer accepted.
QA Specialist- Simply Biotech
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 firstname.lastname@example.org or call 469.895.5514
More information can be found at www.simplybiotech.com
Websitehttp://www.simplybiotech.com/ View all jobs at Simply Biotech
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