QA Validation Specialist II — Sampling & Compliance

Katalyst-Healthcares-; Fort Washington (Montgomery County); On-site; USD 65,000 - 90,000; Full time

Job summary

Katalyst-Healthcares- seeks a Specialist 2, Validation / Technical Assurance to perform incoming sampling, testing, and inspection within the warehouse and production areas. The role acts as SME for sampling of chemicals, raw materials, containers, labeling, and packaging components, ensuring cGMP and FDA compliance.

The position involves supporting material reviews, line clearance, documentation in eBR and SAP, coordinating samples with QC labs, updating SOPs, and assisting in audits and

Qualifications

• Hands-on experience in pharmaceutical QC/QA environments.
• Strong knowledge of cGMP and 21 CFR Part 210/211.
• Experience with incoming sampling and material inspection.
• Familiarity with ERP/WMS workflows and documentation practices.
• Experience in deviation investigations and root-cause analysis.

Responsibilities

• Perform compliant sampling, physical testing, and incoming inspection of materials.
• Support packaging material reviews and disposition workflows in warehouse/production areas.
• Coordinate sample transfer to QC laboratories under chain-of-custody protocols.
• Draft, review, and update SOPs; assist Lean/OpEx initiatives.
• Support internal audits and external regulatory inspections; assist in investigations.
• Train and mentor incoming sampling technicians and inspectors.

Skills

Sampling & inspection

Quality control

Training & mentorship

Cross-functional collaboration

Process improvement

Regulatory compliance

Documentation practices

Troubleshooting

Education

High School Diploma or GED

Associate or Bachelor's degree in Chemistry, Biology, Life Sciences, or related field

Tools

SAP (WM/MM/QM)

LIMS

eBR systems

TrackWise

Veeva Vault

MasterControl

Microsoft Excel

Microsoft Word

Outlook

SampleManager

LabWare

Job description

Katalyst-Healthcares- seeks a Specialist 2, Validation / Technical Assurance to perform incoming sampling, testing, and inspection within the warehouse and production areas. The role acts as SME for sampling of chemicals, raw materials, containers, labeling, and packaging components, ensuring cGMP and FDA compliance.

The position involves supporting material reviews, line clearance, documentation in eBR and SAP, coordinating samples with QC labs, updating SOPs, and assisting in audits and