GxP Systems Specialist Senior

DESCRIPTION

• Collaborate with IT to gather infrastructure and architectural requirements pertaining to relevant projects.
• Manage all project and compliance related issues associated with their project.
• May support, coordinate and interface with regulatory agencies as required in support of regulatory agency inspections.
• Support and maintain Quality programs, policies, processes, procedures and controls ensuring compliance with current Good Manufacturing Practices (cGMP) expectations and established agency requirements/guidelines.
• Consistently demonstrate QUALITY culture and behaviors and perform all duties in accordance with American Regent and Daiichi Sankyo Business Principles, corporate directives, SOPs, policies, and government and industry regulatory guidelines.
• Create and implement business continuity plans, procedures and enhancements.
• Review IT Infrastructure vendor operations and outsourcing arrangements and collaborate with major service providers of IT Infrastructure.
• Perform infrastructure qualification activities, testing sequences and change controls. Oversight of execution with IT team members.
• 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 SOPs and provide SOP review for new systems.
• Perform Validation/Part 11 Assessments for new and existing computer systems.
• Maintain GxP Systems Inventory 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.
• Conduct validation related training to individuals performing various roles within validation projects.
• Participate in the development and improvement of computerized systems to ensure quality and adherence to cGMPs.
• Perform any other tasks/duties as assigned by management.

Position allows for 100% remote work from within the U.S.

Salary: $124,030

QUALIFICATIONS

Bachelor’s Degree in Chemistry, Biology, Information Systems, Pharmacy Management Systems or a related field or foreign equivalent, plus five (5) years of GxP computer systems experience in pharmaceutical or similarly regulated industry. In addition, five (5) years of experience with the following is required:

• Computerized systems regulations, including CFR Part 11
• Quality Systems and current Good Manufacturing Practice (cGMP) requirements (FDA, EU, ICH) and assessing compliance risks
• Providing oversight in implementation and maintenance of GxP computer systems in a validated state
• Validation methodology and software development life cycle (SDLC) principles

Successful candidates must be physically able to wear cleanroom/protective gowning and equipment, including but not limited to gowning, goggles, face shields, and protective gloves.

Due to day-to-day job requirements, upon hiring, individuals will be required to provide evidence of possessing 20/20 vision (corrective lenses allowed) and must undergo Color Blindness Screening (D15).

Please apply at https://www.americanregent.com/Careers using Req. ID 102818.

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, national origin, disability status, protected veteran status, or any other characteristic protected by law.

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 contact John Rossini, Talent Acquisition Director at jrossini@americanregent.com.

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.

Applicants have rights under Federal Employment Laws.

• FMLA poster: https://www.dol.gov/whd/regs/compliance/posters/fmlaen.pdf
• Know Your Rights: Know Your Rights: Workplace discrimination is illegal (eeoc.gov)
• Employee Polygraph Protection Act: https://www.dol.gov/whd/regs/compliance/posters/eppac.pdf

American Regent Inc. endeavors to make https://careers.americanregent.com/ 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.