SRG offers flexible staffing solutions with a national presence. We provide contract, contract-to-hire, direct hire and executive search services. SRG utilizes an innovative approach to identify and qualify talent that is unique to the Staffing industry, featuring a cutting-edge platform that allows us to rapidly and precisely match professionals to client requirements. We have a proprietary database of over one million candidates and maintain continuous contact with our qualified talent.
Title: QA Specialist IV
Location: Portsmouth, NH
Shift Hours: 40 Hour work week - Mon - Fri
Salary: $60.00 Based on Experience
Employment Type: Long Term Contract (Benefits Available)
Environment: A global leader and trusted supplier in the pharma, biotech and specialty ingredients markets. Headquartered in Basel, Switzerland, the company is focused on advanced manufacturing, high-quality control systems, regulatory expertise, and research and development (R&D) capabilities. The company s products and services include active pharmaceutical ingredients (API), stem cell therapies, drinking water sanitizers, vitamin B compounds, organic personal care ingredients, industrial preservatives and microbial control solution to combat viruses, bacteria and other dangerous pathogens.
Key Accountabilities and Duties:
- 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.
Minimum Required Qualifications/Skills:
- Microsoft Office and database management skills,
- organization skills,
- record keeping skills and ability to handle multiple projects.
- 10+ Years Experience