Role Description This role is responsible for the day-to-day administration and configuration of the Kneat eValidation system across all Kindeva sites. The Kneat System administrator creates, updates, and maintains templates, workspaces, disciplines, and document types within Kneat to support site validation activities. Working under the direction of the leader, this role ensures the system is configured correctly, users are supported, and records are maintained in compliance with GxP requirements and internal SOPs. Role Responsibilities - Kneat System Administration: - Create, update, and modify Kneat templates, document types, and document packs for all Kindeva sites, ensuring they reflect current SOPs and validation requirements. - Set up and maintain workspaces and disciplines in Kneat for all Kindeva sites, configuring site-specific settings and ensuring correct workspace structure for each location. - Perform user management activities including account creation, role assignments, access modifications, and periodic access reviews for all Kindeva site users. - Execute and document validation lifecycle activities (IQ/OQ/PQ, protocol execution, discrepancy management, and summary reports) using Kneat workflows under guidance from the validation team. - Provide day-to-day end-user support and troubleshooting for Kneat configuration issues, document routing problems, and execution queries across all Kindeva sites. - Support Kneat system release updates by reviewing release notes, assisting with validation impact assessments, executing regression testing, and documenting results. - Collaborate with Quality, IT, Engineering, and Manufacturing teams to ensure compliant system use and alignment with SOPs and validation requirements. - Assist in training and onboarding users in Kneat functionality and best practices for compliant use. - CDMO experience is a plus, with exposure to supporting multiple clients, projects, or validation strategies within Kneat-supported environments. - Quality Assurance & Compliance: - Support inspection readiness activities by ensuring Kneat records, audit trails, and system documentation are complete and accurate. - Ensure system compliance with GxP, 21 CFR Part 11, EU Annex 11, and other applicable regulations. - Collaborate with cross-functional teams to understand requirements and translate them into system solutions. - Business Process Support: - Collaborate with cross-functional teams to understand requirements and translate them into system solutions. - Support quality processes such as Change Control, CAPA, Deviations, Complaints, and Document Management. - Ensure alignment with GMP and other regulatory requirements. - Global Governance & Standards: - Establish and maintain Kneat procedures, and templates. - Participate in cross-functional governance meetings and harmonization initiatives as directed. - Stay informed on Kneat system updates, new features, and relevant regulatory guidance under the direction of the Kneat Administrator. - Assist in the delivery of Kneat user training and onboarding for new users across Kindeva sites. - System Maintenance & Upgrades: - Coordinate, draft test cases and test Kneat releases and updates including owning the associated change controls. - Monitor system performance and troubleshoot issues. - Maintain documentation for system configuration and validation activities. - Data & Security Management: - Ensure data integrity, backup, and disaster recovery protocols are in place. - Monitor system logs and security alerts; implement corrective actions as needed. Qualifications - Bachelor’s or Master’s degree in Engineering, Life Sciences, Pharmacy, or related field preferred. - 2+ years of experience in validation, quality systems in the pharmaceutical, medical device or biotechnology industry. - Hands-on experience with the Kneat eValidation platform, including template creation, workspace configuration, and user management. - Excellent problem-solving, communication, and organizational skills. - Ability to work independently and in a global, cross-functional team environment. - Hands-on experience with GMP computerized systems, including system validation and regulatory compliance. - Working knowledge of GMP computerized systems, 21 CFR Part 11, and EU Annex 11 requirements in a regulated manufacturing environment. - Kneat admin certification preferred (or willingness to obtain upon hire). - Familiarity with GMP regulatory requirements and the importance of data integrity in a validated system. Company Description Kindeva Drug Delivery is an Equal Opportunity/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, gender, age, national origin, disability, Protected Veteran status, sexual orientation, or any other characteristic protected by federal, state or local law.

Role Description ASRC Federal is currently seeking a Principal Contracts Administrator to join our team. This is a full-time remote position. - Responsible for all aspects of the contract administration life cycle from “cradle to grave” including, but not limited to, supporting Business Development and Program Managers in business opportunity pursuits. - Lead and support proposal activities such as: - Performing financial and business risk analyses - Developing/coordinating risk mitigation strategies - Drafting terms and conditions - Supporting proposal pricing strategy - Ensuring compliance with solicitations - Lead sole source negotiations, ensuring award reflects negotiated agreement, conducting post-award administration, and closeout. - Process Non-Disclosure Agreements, Teaming Agreements, and other business arrangements as needed. - Ensure company commitments are met in accordance with company policies, legal requirements (FAR/DFAR) and customer specifications. - Advise management of contractual rights, obligations and issues as they arise; act as the primary interface with customer contracting officials. Qualifications - Bachelor's degree in Business, Finance, or related field with minimum of 8+ years’ experience in Contract Administration. - Experience with all forms of government solicitations (RFI, RFP, RFQ, OTA and other forms) and managing all forms of government contracts (Cost Type, FFP, T&M, ID/IQ contracts, GWACS, and GSA schedule contracts). - Experience with Non-Disclosure Agreements (NDAs), Teaming Agreements (TAs), etc. - Experience with the review, approval and execution of master contract agreements, amendments/modifications, statements of work, change orders/requests, contract schedules/addendums, etc. - Must be able to represent company as the prime contact on contracts or projects and interact with senior internal/external personnel on significant matters often requiring the coordination of activities across organizational lines. - MS Office Products (e.g. Word, Excel). - Firm understanding of OCI issues and mitigation/avoidance strategies. Requirements - Active participation with NCMA is a plus. - Government/DoD contracting/negotiating experience with a solid working knowledge of FAR/DFARS preferred. - Knowledge of Small Business and 8(a) practices and policies is a plus. - US Citizenship to meet requirements of role and ability to pass a government sponsored background investigation, if needed. Benefits - Competitive pay and benefits packages. - Health care, dental, vision, life insurance. - 401(k) plan. - Education assistance. - Paid time off including PTO, holidays, and any other paid leave required by law. Company Description ASRC Federal is a leading government contractor furthering missions in space, public health and defense. As an Alaska Native owned corporation, our work helps secure an enduring future for our shareholders. Join our team and discover why we are a top veteran employer and Certified Great Place to Work™.

• Analyze environments and issues, and develop automated solutions. • Provide leadership, assisting less experienced people, and as a backup to the manager. • Provide on-call support on a rotating basis. • Provide weekend and off-shift support as needed for sensitive changes and upgrades. • Interact effectively with team members and other FIS teams around the world. • Interact effectively with IBM & colleagues, maintaining knowledge and improving the automation & monitoring environment. • Interact effectively with IBM to debug and improve the automation and monitoring software. • Provide knowledge transfer and other training to coworkers and other groups as needed. • Write, maintain, and document PIPE, REXX and Assembler code. • Standardize automation wherever possible, across 2+ sites - approximately 20 sysplexes/65 LPARs (currently). • Update SA policy, where possible based on 'best practices'. • Perform System Automation (SA) and NetView upgrades. • Write 'help' procedures in NetView HELP panels. • Integrate SA with Omegamon. • Develop TEPS-Omegamon situations for the mainframe. • Convert from other automation tools as needed. • Document team procedures.

Role Description Convertirte en Agente de Viajes independiente, tendrás la capacidad y las herramientas de elaborar itinerarios personalizados, realizar las reservas y brindar a tus clientes una experiencia sin preocupaciones, esto mientras administras tu horario y nicho de mercado. - Comienza tu agencia ofreciendo una diversa selección de destinos y paquetes de turísticos personalizados que cumplan a las expectativas, necesidades y presupuesto de tus clientes. - Ser responsable de la administración de vuelos, alojamiento, transporte y actividades requeridas solicitadas por tus clientes. - Proporcionar un servicio al cliente excepcional antes, durante y después de la experiencia de viaje. - Mantente informado de las novedades y cambios en tu sector elegido. - Asegurar la satisfacción de tus clientes trabajando en colaboración con los proveedores. Qualifications - Experiencia previa en ventas o en el sector de viajes (PLUS). - Conocimiento general sobre destinos turísticos y sistemas de reservas (PLUS). - Habilidades de comunicación, organización y atención al cliente. - Capacidad para trabajar de forma autónoma y gestionar múltiples tareas. - Familiaridad con herramientas digitales (PLUS). - Conocimientos básicos de inglés (deseable). Benefits - La oportunidad de establecerte dentro de la industria de los viajes. - Horarios flexibles y posibilidad de trabajar desde cualquier lugar. - Generar ingresos a través de comisiones por ventas. - Descuentos y ventajas adicionales relacionados con proveedores. - Acceso a credenciales como CLIA o IATA. - Diversas certificaciones ofrecidas por los proveedores. Company Description "Deja que tus sueños vuelen" Agencia de viajes certificada y lista para hacer realidad tus sueños de aventura. Desde playas paradisíacas y parques de diversión, hasta cruceros y ciudades llenas de historia. En Just Go nos aseguramos de cada detalle de tu viaje para que sea perfecto.