Investigator, Logistics

Sharp Services; Bethlehem (Northampton County); On-site; USD 65,000 - 95,000; Full time

Job summary

Sharp Services seeks an Investigator to lead and document investigations relating to non-conformances and complaints at Sharp Clinical sites. The role applies root cause analysis to determine contributing factors and to design CAPAs for prevention, collaborating with internal and external stakeholders.

The Investigator will drive containment actions, improve processes, and support GMP training and quality systems, ensuring timely, accurate reporting and cross-functional coordination.

Qualifications

• Experience leading investigations into non-conformances and complaints.
• Ability to apply root cause analysis tools and CAPA design.
• Strong written communication and documentation skills.
• Collaborative approach with QA, production and training teams.

Responsibilities

• Lead investigations into non-conformances and complaints with timely completion.
• Document investigation findings and root-cause analysis in the corresponding QMS.
• Develop corrective and preventive actions (CAPAs) and monitor effectiveness.
• Collaborate with SME and operations to implement process improvements.
• Support GMP training programs and related SOPs.
• Provide training input to improve issue prevention and containment.
• Adapt to changing priorities and deadlines while maintaining quality.
• Produce clear, detailed investigation reports for QualityOne (QMS).
• Assist in other quality management activities as needed.

Job description

SummaryThe Investigator is responsible to lead, conduct and document investigations relating to non-conformances and/or complaints within the Sharp Clinical sites. The Investigator will utilize root cause analysis tools, critical thinking and interviewing techniques to determine the root and contributing causal factors of non-conformances/complaints. Investigator will offer recommendations to correct and/or prevent recurrence through CAPA design from the root cause conclusion of the investigation. The Investigator will lead, as necessary, the implementation of associated corrective and preventative actions through collaboration, teamwork and influence. The position will work closely and in collaboration with internal and occasionally external stakeholders.

Essential Duties And Responsibilities

• Identifies issues and can independently assess the need for non-conformance and formulate recommended containment actions in conjunction with operational leadership.
• Manage investigations in an effort for timely completion, updating procedures and assistance with training support for correction of errors as required
• Support site departments with investigations, complaints, process improvement and training for NCRS and complaints as well as the subsequent Corrective and Preventive Actions (CAPAs).
• Conduct investigations that identify robust root cause by effectively applying root cause analysis tools across a variety of non-conformance and/or complaint types.
• Observe processes on shop floor, warehouse, and central support functions (Quality Control, Receiving, Distribution) to ensure investigations are objective and detailed.
• Author investigation reports in QualityOne (QMS) utilizing strong organizational and technical writing skills with demonstrated attention to detail.
• Support department leadership with training improvements to prevent reoccurring process issues.
• Work with Quality Systems group to develop process and best practices for managing the GMP training program. Proactively identify and facilitate resolution of potential risks.
• Collaborate with subject-matter experts (SME) to ensure specialized subjects are appropriately addressed. Generate innovative ideas for content and workflow solutions with SME. Coordinate internal meetings/training with Supervisors and impacted areas.
• Must be flexible to meet the needs to the organization when required (competing due dates and customer prioritization)
• Analyze information required for the development or update of policy, procedure and form documentation. Willingness to take on new challenges and build on current skills.
• Assist in other activities (as needed) for Quality management
• Achieve expected key performance measures.
• Other duties as assigned.