Specialist 2, Validation

Katalyst-Healthcares-; Fort Washington (Montgomery County); Presencial; USD 65.000 - 90.000; Jornada completa

Descripción de la vacante

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

Formación

• 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.

Responsabilidades

• 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.

Conocimientos

Sampling & inspection

Quality control

Training & mentorship

Cross-functional collaboration

Process improvement

Regulatory compliance

Documentation practices

Troubleshooting

Educación

High School Diploma or GED

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

Herramientas

SAP (WM/MM/QM)

LIMS

eBR systems

TrackWise

Veeva Vault

MasterControl

Microsoft Excel

Microsoft Word

Outlook

SampleManager

LabWare

Descripción del empleo

Position Summary:

• The Specialist 2, Validation / Technical Assurance provides critical testing, sampling, incoming material inspection, and technical support for the Quality Assurance department within the warehouse/logistics area. This individual serves as a Subject Matter Expert (SME) for sampling and inspection operations covering chemical components, raw materials, bulk products, containers/closures, labeling, and primary/secondary packaging materials, ensuring strict adherence to cGMP, FDA regulations, company SOPs, and safety standards.

Roles and Responsibilities:

• Incoming Sampling & Inspection: Perform compliant sampling, physical testing, and incoming inspection of raw chemical components, bulk drug products, container closures, labels, and packaging components.


• Packaging Disposition & Material Review: Support packaging material reviews, line clearance, component release, and disposition workflows within the warehouse and production areas.


• Laboratory Sample Coordination: Accurately prepare, label, package, document, and transfer samples to the Analytical/QC testing laboratories under strict chain-of-custody protocols.


• SOPs & Continuous Improvement: Draft, review, and update Standard Operating Procedures (SOPs); assist with process improvements, Lean manufacturing, and Operational Excellence (OpEx) projects.


• Audit & Inspection Readiness: Actively support internal quality audits and external regulatory inspections (e.g., FDA); assist in documenting, investigating, and resolving audit observations.


• Investigations & Deviations: Participate in quality investigations, non-conformances (Client), Out of Specification (OOS) findings, and root-cause analysis (RCA) within automated quality systems.


• Training & Mentorship: Serve as an SME to train, mentor, and qualify incoming sampling technicians and inspection personnel on cGMP techniques and sampling tools.


• Component Tracking & Metrics: Track annual testing cycles, re-inspection schedules, vendor qualification samples, and component shelf-life status in ERP/inventory systems.


• Compliance & Record Keeping: Maintain accurate, contemporaneous Good Documentation Practices (GDP) across Electronic Batch Records (eBR), LIMS, and SAP.

Qualifications & Experience:

• Education: High School Diploma or GED required (Associate or Bachelor's degree in Chemistry, Biology, Life Sciences, or related field is a plus).


• Experience: Minimum 4+ years of hands-on experience in a Pharmaceutical, Biopharmaceutical, or OTC manufacturing facility.


• Logistics & Warehousing Systems: Demonstrated experience with warehouse management systems (WMS), inventory control, and raw material intake workflows.


• Quality & cGMP Rigor: Strong knowledge of cGMP guidelines, 21 CFR Part 210/211, and Good Documentation Practices (GDP).


• Communication & Collaboration: Proven ability to communicate effectively across warehouse operators, quality control, lab analysts, and regulatory teams.


• Technical Systems & Tools


• ERP: SAP (WM/MM/QM modules preferred) or similar enterprise ERP.


• LIMS: Laboratory Information Management Systems (SampleManager, LabWare, etc.).


• Quality & Manufacturing Systems: Electronic Batch Records (eBR), TrackWise, Veeva Vault, or MasterControl.


• Office Applications: Microsoft Excel, Word, and Outlook.

Preferred Qualifications:

• Prior experience with AQL (Acceptable Quality Limit) sampling tables (e.g., ANSI/ASQ Z1.4).


• Background supporting Quality Control (QC), incoming inspection, or Quality Assurance (QA) release.


• Exposure to Lean, Six Sigma, 5S, or continuous improvement initiatives.