Lead Quality Inspector

Job Summary

The Lead Quality Inspector is responsible for overseeing the inspection, sampling, testing coordination, documentation review, and release of raw materials, packaging components, bulk products, and finished products in compliance with current Good Manufacturing Practices (cGMP), company procedures, and regulatory requirements. This role serves as a subject matter expert for incoming materials management, laboratory support activities, material disposition, and quality systems processes including deviations, investigations, CAPA, change controls, and supplier quality events. The Lead Quality Inspector provides technical guidance for quality inspection activities, supports continuous improvement initiatives, and partners cross-functionally with Manufacturing, Quality Control, Materials Management, Validation, and external laboratories to ensure product quality and compliance. Adapted from the responsibilities of the QC Sampler role while expanding into quality systems ownership and leadership responsibilities.

Area Of Responsibility

· Perform inspection, sampling, testing coordination, and release of incoming raw materials, packaging components, bulk products, and finished goods in accordance with approved procedures and cGMP requirements.

· Conduct aseptic sampling of raw materials and maintain proper labeling, storage, and inventory control of sampled materials.

· Review material specifications, certificates of analysis, test results, and supporting documentation to determine material disposition.

· Process material status changes and inventory transactions using SAP or other ERP systems.

· Coordinate and manage external laboratory testing for raw materials, in-process materials, environmental monitoring samples, and finished products.

· Execute and coordinate material transfers between Warehouse, Manufacturing, Quality Control, MSTG, and other operational departments.

· Perform analytical water testing including Total Organic Carbon (TOC), conductivity, nitrates, and other routine utility monitoring tests.

· Maintain, clean, calibrate, and troubleshoot laboratory instruments and equipment used within the inspection and sampling areas.

· Manage laboratory support functions, including chemical inventories, laboratory consumables, glassware processing, and weekly water sampling activities.

· Serve as Lead Investigator for quality events, deviations, non-conformances, out-of-trend occurrences, and CAPA investigations.

· Review, revise, and author Standard Operating Procedures (SOPs), material specifications, test methods, forms, and associated quality documentation.

· Initiate and manage Change Controls and CAPAs within TrackWise or equivalent Quality Management Systems.

· Coordinate supplier quality activities including Supplier Change Notifications, supplier investigations, and corrective action requests.

· Collaborate with cross-functional teams to resolve raw material, supplier, manufacturing, and compliance-related issues.

· Maintain inspection logs, sampling records, warehouse quality documentation, and controlled quality records in accordance with Good Documentation Practices (GDP).

· Participate in internal and external audits and support regulatory inspections.

· Provide training and technical guidance to junior inspectors, samplers, and laboratory support personnel.

· Support continuous improvement initiatives focused on compliance, efficiency, process robustness, and data integrity.

· Perform other duties as assigned.

Work Conditions:

· Warehouse environment with regular interaction with incoming materials and production-support areas. [Quality Co...2025).docx | Word]

· Quality Control laboratory environment requiring adherence to GMP and safety practices. [Quality Co...2025).docx | Word]

· Routine exposure to pharmaceutical raw materials, chemicals, laboratory reagents, and cleaning agents. [Quality Co...2025).docx | Word]

· Exposure to moderate noise levels, laboratory equipment, temperature variations, and warehouse traffic. [Quality Co...2025).docx | Word]

· Required use of personal protective equipment (PPE) including safety glasses, gloves, laboratory coats, hair coverings, and respirators when applicable. [Quality Co...2025).docx | Word]

· Occasional support during off-shift, weekend, or holiday operations as business needs require.

Physical Requirements:

• Stand, walk, sit, use hands and fingers to handle or feel, reach with hands and arms, climb or balance, stoop, kneel, crouch or crawl, hear and talk
• Close vision
• Lift up to 25 lbs.
• Operate computer/office machines
• Ability to wear Personal Protection Equipment

Travel Estimate

Up to 5%

Education and Job Qualification

· Associate's degree in Chemistry, Biology, Microbiology, Pharmaceutical Sciences, Quality Assurance, or a related scientific discipline required; Bachelor's degree preferred.

· Minimum English proficiency of Intermediate B1+ level or equivalent. Based on current QC requirements. [Quality Co...2025).docx | Word]

· Strong knowledge of cGMP, GDP, FDA, and regulatory requirements applicable to pharmaceutical manufacturing and quality operations.

· Working knowledge of USP, EP, and compendial testing requirements.

· Proficiency with quality systems including deviations, CAPA, change controls, investigations, and document management processes.

· Experience with TrackWise or equivalent electronic Quality Management System.

· Experience using SAP or other ERP systems for inventory and material control.

· Strong technical writing skills with demonstrated experience authoring and revising SOPs, specifications, protocols, and quality documentation.

· Proficiency in Microsoft Office applications, including Excel, Word, Outlook, and PowerPoint.

· Strong organizational, analytical, and problem-solving skills.

· Demonstrated ability to lead investigations and drive issue resolution across multiple departments.

· Excellent verbal and written communication skills.

Experience

· Minimum of 5 years of experience in Quality Control, Quality Assurance, Materials Management, or Quality Operations within a pharmaceutical, biotechnology, medical device, or other FDA-regulated manufacturing environment.

· Experience with incoming material inspection, raw material release, final product release, and laboratory support operations required.

· Experience supporting regulatory inspections, internal audits, and compliance initiatives preferred.

· Previous experience training or mentoring quality personnel is highly desirable.

· Demonstrated experience working cross-functionally with Manufacturing, Warehouse, Validation, Quality Control, and Supply Chain teams.