Quality Systems/Continuous Improvement Contractor

Title: Quality Systems / Continuous Improvement ContractorLocation: Swiftwater, PADuration: Long Term (12-16 months)Pay Rate: $55-$59/hr on W2Company: Intellectt.IncBenefits Employees hired into this position are eligible for the following benefits, subject to the applicable plan terms and eligibility requirements:Health Insurance: Medical, dental, and vision insurance options are available through a third-party provider. Employees are responsible for paying the full cost of their insurance premiums.Retirement Benefits: A 401(k)-retirement savings plan is available. No employer matching or other employer contributions are provided.Paid Time Off (PTO): No PTO other than that required by applicable state and local lawsManager Notes:Must Have: • bachelor’s degree and 3–5 years of relevant experience • Strong experience with deviations, Quality Systems, continuous improvement, and regulated GMP pharmaceutical or biotech manufacturing environments. • Experience with eBR, Opstrakker, MES, or similar digital manufacturing systems. • Experience with comparable Quality systems such as Qualipso/Veeva is acceptable. Nice to Have Experience/ Skills: • Previous biotech and/or pharmaceutical manufacturing experience strongly preferred. • Familiarity with OEE (Overall Equipment Effectiveness) and using performance metrics to identify equipment/process improvement opportunities. • Background in formulation, filling, lyophilization (freeze-drying), and/or inspection is a plus.Position SummaryThe Quality Systems / Continuous Improvement Contractor will provide dedicated support to pharmaceutical manufacturing operations, with a primary focus on Formulation and Filling. This position will partner with Quality, Operations, Engineering, MSAT, Sterility Assurance, and other cross-functional teams to drive CAPA, Change Control, quality investigations, root cause analysis, and continuous improvement initiatives while maintaining compliance with cGMP and regulatory requirements.Key ResponsibilitiesServe as the CAPA and Change Control point of contact supporting Formulation and Filling improvement initiatives.Independently manage CAPA and Change Control actions, ensuring accurate documentation and timely closure.Lead quality investigations, troubleshooting, root cause analysis, product impact assessments, and corrective/preventive actions.Partner with SMEs and cross-functional stakeholders to resolve manufacturing and quality issues.Provide technical support for component qualification, Overall Equipment Effectiveness (OEE), electronic Batch Records (eBR), Opstrakker, and factory improvement initiatives.Support continuous improvement efforts utilizing 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, technical reports, investigations, CAPAs, and Change Controls.Ensure compliance with current Good Manufacturing Practices (cGMP), Good Documentation Practices (GDP), and applicable regulatory requirements.Support regulatory inspections and audits as required.Required QualificationsMinimum Education: Bachelor’s degree.Experience: Minimum 3–5 years of relevant experience in pharmaceutical manufacturing, Quality Systems, Continuous Improvement, or a related regulated environment.Strong knowledge of cGMP requirements and pharmaceutical manufacturing operations.Experience with formulation, filling, lyophilization, and/or inspection processes.Experience managing CAPAs, Change Controls, quality investigations, and root cause analysis.Knowledge of Lean Manufacturing and Six Sigma methodologies.Strong technical writing, project management, problem-solving, and cross-functional communication skills.Proficiency in Microsoft Excel, Word, and PowerPoint.Experience with iShift, Qualipso, eBR, and Opstrakker preferred.