QA Validation Specialist — GMP & Packaging Expert

Lancesoft; Fort Washington (Montgomery County); On-site; USD 65,000 - 85,000; Full time

Job summary

Lancesoft is seeking a Validation Specialist 2 to provide testing, sampling, inspection, and technical support within the Quality Assurance department for the logistics area. The role acts as a SME for sampling and inspection of chemical components, bulk products, containers and closures, labeling, and packaging materials to ensure GMP and safety compliance.

The candidate will perform sampling/inspection, prepare samples for lab testing, and mentor staff while supporting audits, process

Qualifications

• High School Diploma or equivalent required.
• Minimum 4 years of experience in a pharmaceutical and/or OTC manufacturing environment.
• Warehousing and inventory control system experience required.
• Sampling and inspection experience in a pharmaceutical and/or OTC environment preferred.
• Strong GMP knowledge and compliance focus.

Responsibilities

• Perform sampling and inspection of: Chemical components; Bulk products; Containers and closures; Labeling and packaging materials.
• Prepare, label, and deliver samples to the laboratory for testing.
• Train and mentor sampling and inspection personnel.
• Support audits, regulatory inspections, and audit observation resolution.
• Assist with SOP revisions, process improvements, and continuous improvement initiatives.
• Track packaging component inspection and annual testing requirements.
• Maintain accurate GMP documentation and records.
• Participate in investigations and quality-related activities.

Skills

GMP knowledge

Interpersonal skills

Teamwork

Basic computer proficiency

Education

High School Diploma or equivalent

Tools

SAP

LIMS

Microsoft Excel

MS Office

ERP systems

Electronic batch records

Job description

Lancesoft is seeking a Validation Specialist 2 to provide testing, sampling, inspection, and technical support within the Quality Assurance department for the logistics area. The role acts as a SME for sampling and inspection of chemical components, bulk products, containers and closures, labeling, and packaging materials to ensure GMP and safety compliance.

The candidate will perform sampling/inspection, prepare samples for lab testing, and mentor staff while supporting audits, process