Visual Inspection Program Lead/SME (Contract)

ProPharma Group; Northern (KY); Hybrid; USD 90,000 - 130,000; Full time

Job summary

ProPharma Group is seeking a Visual Inspection Program Lead/SME for a 16-week contract in the United States. The role focuses on enhancing the visual inspection program, defect classification, and sterility assurance across sterile injectables with risk-based methods and documentation improvements.

The ideal candidate will lead assessments, develop actionable recommendations, and deliver quality-system updates while collaborating with cross-functional teams in a hybrid work environment.

Qualifications

• Visual inspection experience required.
• Defect classification and AQL knowledge.
• Inspector qualification for sterile products preferred.

Responsibilities

• Lead assessment activities for the Visual Inspection Program.
• Develop recommendations and prepare deliverables for the workstream.
• Strengthen the program with risk-based enhancements to procedures and QA documentation.

Skills

Visual inspection

Defect classification

AQL

Knapp studies

Inspector qualification

Sterile injectables

Job description

## Visual Inspection Program Lead/SME (Contract)Apply: United States: Full time: Posted Yesterday: JR 10783For the past 25 years, ProPharma has improved the health and wellness of patients by providing advice and expertise that empowers biotech, med device, and pharmaceutical organizations of all sizes to confidently advance scientific breakthroughs and introduce new therapies. ProPharma partners with its clients through an advise-build-operate model across the complete product lifecycle. With deep domain expertise in regulatory sciences, clinical research solutions, quality & compliance, pharmacovigilance, medical information, and R&D technology, ProPharma offers an end-to-end suite of fully customizable consulting solutions that de-risk and accelerate our partners’ most high-profile drug and device programs.**Duration:** approx. 16 weeks (400 hours) **Scope:**To support execution of the Visual Inspection Program Enhancement workstream, requiring a dedicated Program Lead with extensive experience in:* Visual inspection* Particulate-control programs* Defect classification* Inspection qualification* Sterile manufacturing operations This individual will lead all assessment activities, develop recommendations, and prepare the associated deliverables supporting this workstream. The objective is to strengthen the overall visual inspection program through risk-based enhancements to procedures, qualification methodologies, defect management practices, and supporting quality-system documentation **Required Experience*** Visual inspection* Defect classification* AQL* Knapp studies* Inspector qualification* Sterile injectables* 7 years of relevant experience #LI-EB3 We celebrate our differences and strive to create a workplace where each person can be their authentic self. We are committed to diversity, equity, and inclusion. Employees are encouraged to unleash their innovative, collaborative, and entrepreneurial spirits. With a holistic approach as an Equal Opportunity Employer, we provide a safe space where all employees feel empowered to succeed.All applications to roles at ProPharma are personally reviewed by a member of our recruitment team. We do not rely on AI screening tools to support our hiring process. You will always receive an outcome to your application so that you have an answer from us - whether you're successful or not.Whilst ProPharma supports remote working, we also recognise the value that comes from in person collaboration. As such, we encourage any new hires that are based within a reasonably short commute of one of our offices to work on a hybrid basis and spend some time working from that office location, as agreed with your manager. All applications will be treated on their own merit and candidates will not be at any advantage or disadvantage based on their proximity to an office.\\*\\*\\*ProPharma Group does not accept unsolicited resumes from recruiters/third parties. Please, no phone calls or emails to anyone regarding this posting.\\*\\*\\*