Job description

Job Title: QA Specialist IV

Location: Houston TX 77047

Duration: 7 Months

Job Type: Contract

Work Type: Onsite

JOB DESCRIPTION:

• 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
• Provide immediate support to operations and quality control staff to address compliance related concerns
• 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.
• he 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. 10+ Years Experience

Job Types: Full-time, Contract

Salary: $40.00 - $60.00 per hour

Schedule:

• Day shift
• Monday to Friday

Work setting:

• In-person

Application Question(s):

• How many years of experience do you have in mfg. pharma background and cleanroom experience?
• Do you have experience working with EBR (electronic batch record implementation)?
• How many years of experience do you have in Deviation investigations?
• Do you have the required direct QA commercial drug substance/drug product experience or an equivalent amount of aseptic processing and cell therapy manufacturing experience?

Work Location: One location

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