Quality Assurance Specialist

Quality Assurance Specialist

The Specialist Technical Assurance provides testing, sampling, inspection, and technical support for the Quality Assurance department within the logistics area. The role serves as a Subject Matter Expert (SME) for sampling and inspection activities involving chemical components, bulk products, containers and closures, labeling, and packaging materials while ensuring compliance with GMP, safety, and quality requirements.

Key Responsibilities:

• Perform sampling and inspection of:
• Chemical components
• Bulk products
• Containers and closures
• Labeling and packaging materials
• Support packaging material review and disposition activities.
• 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.
• Support safety, environmental, and compliance programs.

Required 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.
• Ability to work effectively with all levels of the organization.
• Strong interpersonal and teamwork skills.
• Basic computer proficiency.
• Required Systems/Technical Skills
• SAP
• LIMS
• Microsoft Excel
• MS Office applications
• ERP systems
• Electronic batch records and automated quality systems experience preferred

Preferred Experience:

• Pharmaceutical/OTC sampling and inspection.
• Quality Assurance or Quality Control support.
• Packaging component inspection.
• Continuous improvement, Lean, and process excellence initiatives.