Easter Seals Jobs

Nature and Scope The individual will be responsible for generating, reviewing and remediating computer system validation protocols in order to ensure that regulatory requirements are met. The individual will be responsible for maintaining system inventory of GxP Systems. The GxP Specialist will report directly to the GxP Manager and will work closely with members of the GxP team, IT and QA Compliance team. Essential duties and Responsibilities Nothing in this job description restricts management's right to assign or reassign duties and responsibilities to this job at any time. * Collaborate with System Owner to develop Design Qualifications, Functional Requirements, User Requirements, Unit test scripts, UAT scripts, validation plans, validation summary report, traceability matrix, IQ/OQ/PQ *Develop department and system SOPs and provide SOP review for new systems. *Perform Validation/Part 11 Assessments for new and existing computer systems. *Maintain GxP System Log and update as necessary. *Participate in cross-functional project teams. *Identify and implement opportunities for continuous improvement related to validation or other compliance practices/issues based on internal compliance issues, industry best practices as well as latest regulatory guidance's and regulatory updates. *Identify, communicate and escalate project and compliance related issues associated with their projects. *Participate in the development and improvement of computerized systems to ensure quality and adherence to cGMPs. *Conduct validation related training to individuals performing various roles within validation projects. *Perform any other tasks/duties as assigned by management. Qualifications and Requirements *Associate's degree in a related field from an accredited college or university or equivalent years' of experience, required. *Minimum of 2+ years' experience working directly with computer system projects/implementations preferred. *Experience in project management practices and techniques. *Familiarity with software development life cycle, GAMP5 approach to software implementation. *Knowledge of pharmaceutical principles, practices and applications. *Proficient with computer hardware and Enterprise software applications (MS Office, MS Project, MS Visio) *Knowledgeable in principles and practices of computer validation and qualification. *Demonstrates ability to perform detail-oriented work with a high degree of accuracy. *Effective time management and interpersonal skills. *Strong organizational skills, planning skills and must work effectively within teams. *Strong Business English for documentation including spelling, grammar and punctuation. Physical Environment and Physical Requirements *Physically able to wear cleanroom/protective gowning and equipment, including but not limited to gowning, goggles, face shields, and protective gloves. PPE is essential for the health and safety of employees. *Specific vision requirements include 20/20 near vision (can be corrected with eyeglasses or contacts) and color vision. American Regent celebrates diversity and we are committed to creating an inclusive environment for all employees. We are an Equal Opportunity Employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability status, or protected veteran status. American Regent Inc. endeavors to make https://americanregent.com/Careers accessible to any and all users. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process, please email hrtalentacquisition@americanregent.com. We are an Equal Opportunity Employer and all qualified a