Job description

Position Summary / Objectives The Manufacturing Technical Administrator is responsible for maintaining accurate, compliant documentation to support manufacturing operations, including batch records, SOPs, operating instructions and various other technical documentation. They will be responsible for submitting and managing Engineering Change Orders (ECO) relevant to the documents they revise. As a SmartSolve super user, this individual manages document control and CAPA workflows while also organizing equipment records in the ERP system, supporting new product introductions, and driving continuous improvement. The role includes leading product assessments, assisting in CAPA investigations, and collaborating closely with cross-functional teams on the cleanroom floor to ensure documentation and processes align with current practices and regulatory standards. Essential Job Functions • Develop and revise batch records, SOPs, validation documents, material specifications and other documents to support manufacturing, new products, and continuous improvement. • Facilitate periodic document reviews through onfloor observation, staff feedback, and collaboration with team leaders and supervisors. • Initiate, manage, and close Engineering Change Orders (ECOs) related to document updates. • Serve as SmartSolve super user to support document control and CAPA system administration. • Conduct product assessments and participate in CAPA investigations to support root cause analysis and remediation. • Organize and maintain equipment, calibration, and preventive maintenance records in the ERP system (e.g., INFOR). • Track and support training in execution related to revised procedures and new documentation. • Support internal and external audits (e.g., FDA, Notified Body) through documentation readiness and procedural clarity. • Engage with operators and floor staff to validate procedures and collect realtime feedback. • Assist in personnel qualification and GMP/ISOrelated training. • Recommend and implement workflow improvements to enhance operational efficiency. • Provide backup support to Product Leads during absences or vacancies. • Execute other documentation, investigation, and compliancerelated tasks as assigned. Competencies • Technical Writing & Documentation Management • SmartSolve/eQMS Proficiency • Equipment & ERP Record Keeping • CAPA & Root Cause Investigation • Collaboration & Cross-Functional Communication • Attention to Detail & Compliance • Initiative, Problem Solving & Accountability Physical Demands The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. While performing the duties of this job, the employee will be required to gown in accordance with cleanroom protocols and spend time in classified cleanroom environments, which includes walking, standing for extended periods, and navigating around manufacturing equipment. The employee may also be required to sit; use hands to handle or feel objects, tools, or controls; reach with hands and arms; climb stairs; and communicate verbally. The employee must occasionally lift or move materials and office supplies up to 50 pounds. Education, Experience and Certification • BA/BS degree or equivalent education/experience; 3+ years in a similar role • Familiarity with manufacturing and quality in regulated environments (cGMP, ISO) • Strong writing, editing, and document review skills • Proficient in Microsoft Word, Excel, and PowerPoint • Excellent communication, organization, and problemsolving skills • Works independently and collaborates effectively across teams and departments • Flexible and adaptable to shifting priorities and schedules • Regenity offers a comprehensive rewards package: o Company performance bonus eligible • 401(k) plan with company contribution oPaid time off and holidays • Medical, Rx, dental and vision insurance oCompany paid life and AD&D insurance • Wellness and Employee Assistance Program (EAP) oTuition Reimbursement • Salary Range: $65,000 - $75,000 per year Regenity Biosciences, Inc. is an Equal Opportunity Employer. We consider applicants for all positions without regard to race, color, religion, creed, gender, national origin, age, disability, marital or veteran status, sexual orientation or any other legally protected status. Regenity Biosciences, Inc. celebrates the diversity of our team. We believe that talent, drive, and experience are the only relevant criteria for considering new team members.

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