Manufacturing Associate II

Immediate need for a talented Manufacturing Associate II . This is a 12+ months contract opportunity with long-term potential and is located in Swiftwater, PA (Onsite). Please review the job description below and contact me ASAP if you are interested.Job ID: 26-09746Pay Range: $27 - $29/hour. Employee benefits include, but are not limited to, health insurance (medical, dental, vision), 401(k) plan, and paid sick leave (depending on work location).Key Responsibilities:TECHNICAL TASKS AND DELIVERABLES / SCOPEThe Continuous Improvement Contractor will execute the following activities and responsibilities:Cross-Functional Collaboration and SupportServe as an individual contributor and active member of cross-functional teams providing support to Production Control Units (PCUs)Act as CAPA (Corrective and Preventive Action) and Change Control point of contact for the Formulation and Filling Improvement Program (FFIP), with emphasis on Formulation and Filling areasFacilitate cross-functional interfacing activities with key stakeholders in a positive and collaborative manner, including, but not limited to:Quality ControlManufacturing Science and Technology (MSAT)Sterility AssuranceEngineeringOperationsQuality AssuranceCAPA and Change Control ManagementComplete all required training to independently own CAPA action items, Change Control action items, and author related documentsEnsure timely closure of assigned CAPA and Change Control action itemsMaintain accountability for deliverables and adherence to established timelinesTechnical Support and Process ImprovementProvide technical support for:Component qualification activitiesOverall Equipment Effectiveness (OEE) improvement initiativesElectronic Batch Record (eBR) implementation and optimizationOpstrakker system utilizationGeneral factory improvement projectsFacilitate resolution of unresolved issues and deliverables by:Leading cross-functional meetingsPositively influencing functional managersRemoving obstacles and barriers to progressManaging projects and competing priorities effectivelyOperational Excellence and Metrics ManagementCreate and maintain a proactive operational environmentMonitor and communicate key performance metrics to team members and support functionsUtilize the \"+QDCI\" Visual Management Systems to drive continuous improvement in key metricsWork within the Continuous Improvement framework to identify and implement improvement opportunitiesCompliance and Quality AssuranceEnsure strict compliance with all regulatory requirements and current Good Manufacturing Practices (cGMPs)Maintain adherence to good documentation practices to ensure delivery of safe, quality, and effective productsSupport regulatory inspections and audits as requiredProfessional DevelopmentProactively identify opportunities for professional growth and developmentStay current with applicable sciences and methodologies that enhance team capabilitiesContribute to knowledge sharing and team skill developmentKey Requirements and Technology Experience: Key skills: - Continuous Improvement professional with 3–5 years of experience in pharmaceutical manufacturing and strong knowledge of cGMP environments, particularly in formulation and filling operations.Ideal candidates will have hands‑on experience managing CAPA and Change Control activities, authoring technical documentation, and supporting cross‑functional teams including Quality, MSAT, Engineering, Operations, and Sterility Assurance.They should bring expertise in Lean/Six Sigma methodologies, equipment qualification, OEE improvement, and electronic systems such as eBR, Opstrakker, and Qualipso.Strong candidates excel in communication, technical writing, project management, and influencing across teams.Proficiency with Microsoft Office and familiarity with ERP systems (iShift preferred) are important. Candidates must be adaptable, detail‑oriented, and capable of driving continuous improvement in a fast‑paced, regulated environment.Experience: 3-5 years experience in technical documentation and cGMP systems.Manufacturing Operations: Deep understanding of cGMPs and pharmaceutical manufacturing activities, including:Formulation processesFilling operationsLyophilization (freeze-drying) processesContinuous Improvement Methodologies:Comprehensive knowledge of Lean Manufacturing concepts and principlesSix Sigma methodology and toolsChange Management: Demonstrated experience in Change Management processes and executionProtocol and Report Development: Proven experience in authoring protocols and technical reportsMicrosoft Office Suite: Proficient in Excel, Word, and PowerPointEnterprise Resource Planning (ERP): Knowledge of ERP systems (iShift preferred)Quality Management Systems: Experience with Quality Management Systems (Qualipso)Electronic Systems: Familiarity with eBR and Opstrakker systemsCommunication: Excellent interpersonal and communication skills with ability to engage effectively across all organizational levelsLeadership: Strong management by influence skills; ability to lead and actively participate on cross-functional teamsTechnical Writing: Excellent technical writing skills for generation of protocols, reports, and Change ControlsProject Management: Strong project management and organizational skillsTime Management: Demonstrated ability to prioritize tasks and manage time effectively in a fast-paced environmentFlexibility: Adaptability to change priorities and business needsProblem-Solving: Analytical mindset with ability to identify root causes and implement effective solutionsOur client is a leading Pharmaceutical Industry and we are currently interviewing to fill this and other similar contract positions. If you are interested in this position, please apply online for immediate consideration.Pyramid Consulting, Inc. provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.By applying to our jobs you agree to receive calls, AI-generated calls, text messages, or emails from Pyramid Consulting, Inc. and its affiliates, and contracted partners. Frequency varies for text messages. Message and data rates may apply. Carriers are not liable for delayed or undelivered messages. You can reply STOP to cancel and HELP for help. You can access our privacy policy here.