Pharma Materials Quality & GMP Specialist

RXinsider LTD.; West Columbia (SC); On-site; USD 42,000 - 64,000; Full time

Job summary

RXinsider LTD. seeks a Quality Operations Materials Management Specialist to perform inspection, sampling, and disposition of raw materials, production components, and resins.

You will ensure compliance with GDP/ALCOA++ and assist with documentation and COA generation in a GMP environment. The role requires 2+ years in pharma, familiarity with LIMS, and ability to work in a team while maintaining strict quality standards.

Qualifications

• High school diploma or GED required.
• Minimum of 2 years of related experience in the pharmaceutical industry preferred.
• ISO-8, ISO-7, and/or ISO-5 cleanroom experience preferred.
• Experience with ALCOA++ GDP and GMP practices.

Responsibilities

• Perform incoming inspection on raw materials, production components, and resin.
• Adhere to ALCOA++ principles for GDP.
• Review shipping and supplier documentation for accuracy.
• Collect samples using AQL rules per ANSI/ASQ Z1.4 and MIL-STD 105E.
• Use LIMS to create batches, collect samples, disposition batches, and generate a COA.
• Manage inventory system for receiving, disposition, retest, adjustments, and expiry monitoring.
• Determine disposition based on inspection/testing results.
• Submit samples to QC departments for testing as required.
• Perform quality verification/review of company documents.
• Follow cGMP procedures.
• Pass medical screenings for safe handling of pharma materials.
• Perform other duties as required.

Skills

Microsoft Word

Microsoft Excel

Inventory management

ALCOA++ GDP

Communication

Integrity

QA/GMP knowledge

Prioritization

Teamwork

Independent work

Education

High school diploma or GED

2 years pharma-related experience

ISO cleanroom experience (ISO-8/7/5)

Tools

LIMS (LabVantage)

Inventory management system

Job description

RXinsider LTD. seeks a Quality Operations Materials Management Specialist to perform inspection, sampling, and disposition of raw materials, production components, and resins.

You will ensure compliance with GDP/ALCOA++ and assist with documentation and COA generation in a GMP environment. The role requires 2+ years in pharma, familiarity with LIMS, and ability to work in a team while maintaining strict quality standards.