Pharma Quality Systems & Continuous Improvement Contractor

Intellectt Inc; Swiftwater (Monroe County); On-site; USD 76,000 - 81,000; Full time

Benefits offered by this job

Health Insurance

401(k) Retirement

PTO/State law compliance

Job summary

Intellectt Inc in Swiftwater, PA seeks a Quality Systems / Continuous Improvement Contractor to support pharmaceutical manufacturing operations focusing on Formulation and Filling. You will drive CAPA, Change Control, investigations, and cross-functional improvements while ensuring cGMP compliance.

The role requires 3–5 years in regulated pharma environments, experience with eBR/Opstrakker/MES, and strong technical writing and problem-solving skills. On-site position with benefits outlined.

Qualifications

• Bachelor’s degree and 3–5 years of relevant experience in pharmaceutical manufacturing or a related regulated environment.
• Strong knowledge of cGMP requirements and pharmaceutical manufacturing operations.
• Experience with CAPAs, Change Controls, quality investigations, and root cause analysis.
• Experience with formulation, filling, lyophilization, and/or inspection processes.
• Proficiency in Microsoft Excel, Word, and PowerPoint.

Responsibilities

• Provide both CAPA and Change Control support for Formulation and Filling improvement initiatives.
• Independently manage CAPA and Change Control actions with accurate documentation and timely closure.
• Lead quality investigations, troubleshooting, root cause analysis, and corrective/preventive actions.
• Collaborate with SMEs and cross-functional stakeholders to resolve manufacturing and quality issues.
• Provide technical support for OEE, eBR, Opstrakker, and factory improvement initiatives.
• Support continuous improvement using Lean Manufacturing, Six Sigma, and +QDCI Visual Management principles.
• Monitor and communicate key performance metrics and identify opportunities for process improvement.
• Author and maintain high-quality protocols, reports, investigations, CAPAs, and Change Controls.
• Ensure compliance with cGMP, GDP, and applicable regulatory requirements.
• Support regulatory inspections and audits as required.

Skills

Lean Manufacturing

Six Sigma

Cross-functional communication

Problem solving

Technical writing

Education

Bachelor’s degree

Tools

eBR

Opstrakker

MES

Qualipso

Veeva

Job description

Intellectt Inc in Swiftwater, PA seeks a Quality Systems / Continuous Improvement Contractor to support pharmaceutical manufacturing operations focusing on Formulation and Filling. You will drive CAPA, Change Control, investigations, and cross-functional improvements while ensuring cGMP compliance.

The role requires 3–5 years in regulated pharma environments, experience with eBR/Opstrakker/MES, and strong technical writing and problem-solving skills. On-site position with benefits outlined.