Title: QA Specialist IV

• Location: Houston, TX
• Industry: Pharmaceutical
• Hours: Mon - Fri 8am - 5pm
• Salary: $68.12 hr.
• Employment Type: Long Term Contract

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 match professionals rapidly and precisely to client requirements. We have a proprietary database of over one million candidates and maintain continuous contact with our qualified talent.

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 responsibilities:

• 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.

Key Requirements:

• 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.
  

Work Experience:

• 10+ Years Experience
• Candidates must be local to Houston, able to work onsite
• Strong organizational skills and record keeping with the ability to work overtime when needed.
• Ability to engage and interview co-workers to obtain relevant information pertaining to investigations.
• Strong attention to detail and organizational skills.
• Strong communication skills (written and oral).
• Independent and self-motivated.
• Familiarity with cGMP quality systems.
• Strong typing and computer skills, including efficiency using Microsoft Office Suite (Word, Excel, Powerpoint).

Education:

Bachelors - Life Sciences or Engineering

EOE/ADA