QA Specialist II
Verification of the company's compliance with ISO/cGMP quality system requirements as well as knowledge of PICS Guide to Good Manufacturing Practices Part 1 and 2 or the EU Guidelines to Good Manufacturing Practice Medicinal Products for Human and Veterinary Use, including Annex 1.
Provide immediate support to operations and quality control staff to address compliance related concerns (QA ?on-the-floor' support).
Make independent quality-related decisions based on regulatory and compliance knowledge and provide independent quality support to project teams.
Audit internal quality system elements in manufacturing and operational support areas.
Provide oversight for compliance of Change Controls, CA/PA and investigations, OOS and deviations.
Perform external audits of suppliers/vendors/off-site facilities.
Act as a customer interface during on-site audits, conference calls and other standard means of communication.
Independently identify and manage special projects or QA compliance functions as agreed upon with QA management.
Prioritize and manage a variety of projects simultaneously. May need to lead and direct the work of others.
Review and approve validation documents. Review and Master Batch Records (MBR) and supporting documents.
Perform review/release of batch records, as needed.
Direct QA commercial drug substance/drug product experience required or an equivalent amount of aseptic processing and cell therapy manufacturing experience.
GMP compliance and Part 11 compliance knowledge preferred.
Experience with oversight of aseptic processing and the associated international aseptic processing regulations.
Excellent written and oral communication to include accurate and legible documentation skills; ability to work in a fast paced environment; team oriented; independent work skills and a strong work ethic.
The ability to interface and communicate directly with clients is required. Microsoft Office and database management skills, organization skills, record keeping skills and ability to handle multiple projects.
3-5 Years Experience
SRG is an Equal Opportunity Employer - All qualified applicants will receive consideration without regard to race, color, religion, gender, national origin, age, disability, veteran status, or any other factor determined to be unlawful under applicable law.
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