QA Specialist - Pharma #W2 role - Intellectt INC

Shifts: 7am-7pm or 7pm-7am (12-hour shifts)

The QA Specialist provides Quality Assurance support for GMP manufacturing, overseeing master/working cell banks, biological bulk drug substances, and finished products for human consumption. Responsibilities include on-the-floor QA oversight, compliance monitoring, and quality improvements.

• Conduct QA oversight of GMP operations (75% of time on the floor).
• Support client projects with room release, process observation, and real-time documentation review.
• Perform Acceptable Quality Limit (AQL) visual inspections.
• Review and approve batch documents.
• Generate/revise GMP documentation and compile deviations.
• Audit manufacturing areas for adherence to procedures.
• Participate in quality and process improvement initiatives.
• Provide guidance on cGMP compliance and training.

• Education:
  • Master's degree in a scientific field (0-2 years of experience)
  • OR Bachelor's degree (2-4 years of experience)
• Experience: Quality Assurance/Control in biologics or regulated industries.
• Knowledge: Familiarity with GMPs, 21 CFR regulations, and biological manufacturing processes.
• Skills: Proficiency in Microsoft Office, LIMS, Master Control, and Trackwise preferred; strong analytical and decision-making abilities; teamwork and independent work capability.