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Job DescriptionAt Viral Vector Services (VVS) a division of Thermo Fisher Scientific we deliver, from process development through commercial supply, we offer the expertise and resources vital to help clients deliver innovative gene therapies. Placed in the forefront of our leading and ground breaking Cell and Gene Therapy business enabling clients to cure genetic, rare, and otherwise untreatable diseases.Location/Division Specific InformationCambridge, MA - VVSHow will you make an impact?The GMP services specialist position will lead services that have a high impact to cleanroom environments and GMP compliance. You will deliver outstanding performance on contracted services such as cleaning, Supplies and Pest control at the Cambridge and Somerville sites.They will develop and lead reporting of cost expense for all labor, supplies and contracted services to meet or exceed budgeted targets, while working in collaboration with Finance and the field to ensure that financial transactions are processed in an orderly and timely fashion-goal to ensure invoice amounts are correct and paid on time.What will you do?Ensure satisfaction of GMP services such as cleanroom GMP cleaning, gowning supplies and pest control.Own the pest control program by directly coordinating with Pest control service provider. Audit pest control program. Prepare and analyze pest control trend reports. Possess ability to conduct investigations and provide Subject Matter Expertise for them.Lead the GMP cleaning program. Coordinate cleanings with vendor and manufacturing Drive accurate cleaning schedules and ensure GMP compliance for cleanrooms. Ensure cleaners are trained and qualified to perform cleaning. Conduct routine audits to gauge cleaning performance and compliance to cleaning procedures. Ensure appropriate supplies are stocked within cleanrooms.Lead GMP supplies inventories and deliveries. Ensure sufficient stock exists and address as needed. Address any supply chain issues and call out as needed.Ensure a high service level is met by contractors for their functional area. This includes but is not limited to Quality compliance, PM completion, Good Documentation Practices, training completion and overall performance.Ensure areas and processes are in optimum conditions for audit readiness and complianceOwn vendor performance and governance process for daily operations, Including development and administration of data gathering, vendor audit performance tracking, establishing action plans and immediate execution. Ensure recurrent services vendors implement per contracts. Complete daily building inspections, and monthly job-walks with vendors to ensure contracted scope is met.Drive continuous process improvement, accepting and encouraging Thermo Fisher’s PPI tools and standard processes. Coordinate operations and projects with internal and external partners such as Manufacturing, Labs, Facilities, contractors, vendors and other partners as needed.Meet with all standard operating procedures, codes and regulations.Perform additional job duties as requested.Ensure 'Safety First' is embraced at workplace.Supervise the development and management of cost expense for all labor, supplies and contracted services to meet or exceed budgeted targets. Work in partnership with Finance and the field to ensure that financial transactions are processed in an orderly and timely fashion-goal to ensure invoice amounts are correct and paid on time.Deliver via implementing procurement plan, improved labor efficiency and increase abilities to self-perform.How will you get here?EducationHigh school diploma or GED +5 years’ experience, Associate's degree and 2+ years of related experience, OR Bachelor's degree in Engineering, Life Science or related field and 1+ years of related experience.Knowledge, Skills, AbilitiesDemonstrated ability to lead cross-functional teams and collaborate across the business.Strong analytical and problem-solving skills; great attention to detail and excellent decision making process.Expertise in running small and medium technical and/or capital projects in a GMP environment.Excellent written and oral communication skills both internal and external.Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.
