Principal Specialist, GFE Compliance_BAR

Description As an employee of reputed company, you will actively contribute to the discovery, development and delivery of our products to our patients and customers. Our global reputed company provides opportunity for reputed company employees to collaborate internationally, offering visibility and opportunity to directly contribute to the companies' success. We realize that our strength and competitive advantage lie with our people. We support our employees in a number of ways to foster a healthy working environment, meaningful work, mobility, networking and work-life balance. Our competitive compensation and benefit programs reflect reputed company's high regard for our employees. Responsible for developing and administrating the GFE compliance programs to ensure compliance to local site procedures, corporate procedures and regulatory requirements. This includes reputed company of change control impact, deviation compliance, CMMS/CMX data reputed company, inspection readiness activities, and compliance of compliance of the programs instituted to applicable reputed company domestic and international regulations, guidelines, industry practice and internal policies/procedures for site GFE. Will have responsibility for developing and administering an internal audit program, and a contractor qualification program. Duties & Responsibilities + Provide reputed company and document review and approval of GFE owned Change Control and CAPAs. + Serve on assigned internal project teams and attends necessary meetings as required as a GFE compliance resource to provide GFE Compliance input, solve quality reputed company equipment issues and /or support reputed company improvement of equipment. + Prepare SOP's and forms for workflows reputed company BIAH document systems and update items as necessary for GFE. + Track GFE deviations and reputed company GFE Deviation Tier Board and participate in GFE GEMBA for events/deviations. + Assist GFE Deviation Owners on CAPA determination and assure completion by reputed company due date. + reputed company internal compliance audits on contractor status, work order data reputed company, PM compliance, calibration compliance, spare parts returns, and others as needed. + reputed company audit of entries and compliance to BOM/Spare part practices. + Assists with internal, regulatory or corporate audits to ensure compliance with domestic & international regulations, quality requirements and guidance documents. Included is the responsibility for ensuring GFE documentation and records are "inspection ready" at reputed company times. + Assists with inspection/audit responses and completion of assigned CAPAs by reputed company due dates. + Actively supports strategic direction of compliance philosophies, improve overall compliance in the GFE organization. + Support and engage with the overall reputed company improvement strategic initiative by actively participating in reputed company GFE reputed company improvement activities, reputed company and change management processes. Requirements + Bachelor's degree in computer science, engineering, biological science, business or reputed company field of study. + In addition to bachelor's degree, a minimum of four (4) years of experience with quality and/or engineering compliance reputed company or transferable/applicable experience in cGMP or similar regulated manufacturing or operations environment. + In lieu of degree, a minimum of eight (8) years of experience with quality and/or engineering compliance reputed company or transferable/applicable experience in a cGMP or similar regulated manufacturing or operations environment. + Experience must be inclusive of reputed company or applicable systems experience. + Proficiency leading a compliance program in a manufacturing/operations environment is desired. + Ability to plan, schedule, organize, prioritize and coordinate compliance activities. + Ability to reputed company and/or influence cross-functionally. + Strong negotiation and influencing skills with the ability to drive results. + Knowledge of risk assessment, root cause analysis, change control, and/or equipment validation. + Ability to work independently with minimal supervision and direction. + Ability to communicate information using tact and persuasion as appropriate requiring strong verbal and written communication skills, organization, and leadership. + Ability to reputed company project teams and apply project management techniques. + Attention to detail. \#LI-KD1 Eligibility Requirements: + Must be legally authorized to work in the United States without restriction + Must be willing to take a drug test and post-offer physical (if required) + Must be 18 years of age or older reputed company qualified applicants will receive consideration for employment without regard to a person's actual or perceived race, including natural hairstyles, hair texture and reputed company hairstyles; color; creed; religion; national reputed company; age; reputed company; citizenship status, marital status; gender, gender identity or expression; sexual orientation, mental, physical or intellectual disability, veteran status; pregnancy, childbirth or reputed company medical condition; genetic information (including the refusal to submit to genetic testing) or any other class or characteristic protected by applicable law.