Visual Inspection Strategy Lead

Nephron Pharmaceuticals Corporation

Columbia (SC)

Hybrid

USD 120,000 - 160,000

Full time

6 days ago

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Job summary

Nephron Pharmaceuticals Corporation seeks a Visual Inspection Program Leader to provide technical leadership for the Visual Inspection Program across sterile injectable and ophthalmic products. This role acts as SME and program owner, guiding MVI/AVI strategies, defect standards, AQL, and PoD studies while ensuring audit readiness and continuous improvement.

The position requires a strong background in pharmaceutical visual inspection, regulatory compliance, and cross-functional collaboration,

Qualifications

Bachelor's degree in Pharmaceutical Sciences, Chemistry, Biology, Engineering, Life Sciences, or a related scientific or technical discipline required.
7+ years of progressive experience in pharmaceutical manufacturing, quality, visual inspection, validation, technical operations, or a related discipline.
Experience leading cross-functional technical projects from strategy and planning through execution, implementation, and effectiveness monitoring.
Experience supporting regulatory inspections, customer audits, deviations, investigations, CAPA, change controls, and other quality systems activities as a technical SME.
Experience with statistical analysis, defect/reject trending, data interpretation, and risk-based decision-making preferred.
Experience with automated inspection technologies, inspection equipment qualification, or MVI/AVI comparability assessments highly preferred.
Experience working within aseptic processing and sterile manufacturing environments highly preferred.

Responsibilities

Own and provide technical leadership for the Visual Inspection Program, including program strategy, governance, standards, procedures, protocols, technical reports, and continuous improvement initiatives.
Develop, review, approve, and maintain technical documentation supporting visual inspection activities, including: inspector training, qualification, and requalification programs; defect classification standards and libraries; defect test sets and test set lifecycle management; AQL sampling strategies and acceptance criteria; MVI and AVI strategies; visual inspection validation and qualification protocols; PoD study protocols and reports.
Establish scientifically sound and risk-based approaches for assessing inspection capability, defect detectability, inspection effectiveness, and product quality risk.
Lead defect classification, defect characterization, reject trending, and particulate identification initiatives to improve product and process understanding.
Develop, qualify, and maintain defect standards that represent actual manufacturing defect populations and appropriately challenge inspection systems.
Evaluate inspection program performance using statistical and data-driven approaches and translate findings into actionable technical improvements.
Partner cross-functionally to drive process improvements and implement upstream particulate control strategies.
Serve as SME for Visual Inspection during client and regulatory audits, ensuring alignment with FDA, PDA, USP, and industry best practices.
Provide SME support for manufacturing operations, deviations, and investigations, ensuring thorough root cause analysis and effective resolutions.
Deliver technical guidance on inspection methods, including validation activities and MVI to AVI performance comparisons.
Drive project execution across the full lifecycle, including strategic planning, timeline development, and cross-functional resource management.
Lead and mentor team members, fostering talent development through coaching, knowledge sharing, and performance guidance.
Prioritize and delegate tasks effectively to optimize team productivity and meet organizational goals.
Demonstrate strong communication, presentation, and influencing skills to engage stakeholders, clients, and internal teams.
Assist with additional work duties or responsibilities as evident or required.