Description

Work ScheduleFirst Shift (Days)Environmental ConditionsAble to lift 40 lbs. without assistance, Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc... allowed, Cold Room/Freezers -22degreesF/-6degrees C, Fluctuating Temps hot/cold, Laboratory Setting, Loud Noises (Equipment/Machinery), Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.), Strong Odors (chemical, lubricants, biological products etc.), Warehouse, Will work with hazardous/toxic materials, Working at heightsJob Description<div><div>When you’re part of the team at Thermo Fisher Scientific, you’ll do important work. And you’ll have the opportunity for continual growth and learning in a culture that empowers your development. With revenues of more than $40 billion and the largest investment in R&D in the industry, we give our people the resources and opportunities to make significant contributions to the world. Discover Impactful Work: Through Unity Lab Services, we offer integrated lab services, support, and supply management with customized service offerings and world-class experts to address our customers' unique laboratory business needs.The Lead Manufacturing Support Specialist performs a wide range of materials management inventory and coordination activities supporting Vertex's materials supply chain. This position will primarily support the manufacturing facility located in the Cambridge, MA and Boston locations. This role is required to perform and document daily warehouse operations in a cGMP environment.A day in the Life: <ul><li>Receive and inspect materials in accordance with SOPs.<ul><li>System: Oracle, Veeva, Coupa, Lims (samples)</li><li>SOP’s: SOP-0964</li><li>Decision making: transfer material on plastic pallets, inspect material for damage, verify physical material to material specification (TDS), receive PO in Coupa, remove cardboard and throw in compactor, fill out receiving forms (SOP-0964A and SOP-0964B), receive item In Oracle, print labels from Oracle, label all material down to the smallest unit possible, place material in correct temperature condition according to material specification, utilize forklift and order picker to put material into racking.</li></ul></li><li>Pull Sample/Retains for incoming material<ul><li>System: Oracle, Lims, Veeva</li><li>SOP’s: SOP-0964, SOP-1009, SOP-0798</li><li>Decision making: Follow material specification on the number of samples and retains that are required per item, Place samples and retains under lock and key for storage, fill out retain logbook and sample submission form, ensure samples and retains are transacted out of the system, coordinate delivery with QC and send samples at appropriate temperature</li></ul></li><li>Transfer of materials to and from the warehouse using an effective workflow.<ul><li>System: Oracle, Temperature Controlled Truck/Unit (TCV), Temperature Monitors</li><li>SOP’s: SOP-1280</li><li> Decision making: Coordinate with receiving warehouse on deliveries, Set the TCV unit to the correct set point, prior to loading ensure TCV is within loading range, fill out SOP-1280A logbook to record time and temperature, start temperature monitor and load with material, once TCV is back in range and material loaded drive to destination, record required information on SOP-1280A logbook at receiving site, unload and stop temperature monitor, ensure it did not alarm, have paper work signed (SOP-0964C) for proof of delivery and return to distribution center.</li></ul></li><li>Lead all the daily ERP requests such as material transfers and production requests.</li><li>Store materials in appropriate GMP conditions according to material TDS<ul><li>System: Oracle, Veeva</li><li>Sop-0964</li><li>Decision making: Store material in the correct GMP conditions utilizing Veeva to retrieve the material specification (TDS). Following TDS for storage condition and storing the material correctly in Oracle (systematically and physically)</li></ul></li><li>Confirms the completion and tracking of supply chain supply-related documentation</li><li>Must be proficient in the use of the inventory management system (ERP)<ul><li>System: Oracle</li><li>Sop’s: SOP-0964, SOP-1108, WI-0835</li><li>Decision making: execute real time transactions for material transfers, material receipts, material issuing, batch creation, manual consumption, and IRISO transactions</li></ul></li><li>Assist in working with Freight Forwarders, 3PLs, Brokers and Direct Carriers to address logistics issues and needs.<ul><li>System: World Courier, Fedex Custom Critical</li><li>SOP’s: SOP-0964</li><li>Decision making: Working with World Courier and Fedex Custom Critical to schedule shipments, ensure the appropriate temperature is requested for items shipping domestically or internationally, work cross functionally with logistics to have all required custom documentation is accurate and clears customs within a timely manner</li></ul></li></ul><ul><li>Work with various cross-functional groups (such as Quality, Tech Ops, Regulatory, suppliers, etc.) to proactively and collaboratively resolve issues that may block the timely flow of materials or projects<ul><li>System: Oracle, Veeva, Coupa</li><li>Sop’s: N/A</li><li>Decision making: Some examples - Escalate if items are being requested for production but are in quarantine status, escalate to procurement team on missing documentation or damaged products from suppliers, material shortages, escalate information to management if needed</li></ul></li></ul><ul><li>Review data from temperature monitoring devices and EMS as appropriate. Investigate and resolve any temperature excursions. <ul><li>System: Visala (ViewLinc EMS), Sensitech Temperature Monitors</li><li>SOP’s: SOP-0964, VV-QUAL-112935</li><li>Decision Making: Escalate temperature excursions from temperature monitors to management, acknowledge “warnings” in Visala and escalate alarms. Be a representative in triage meetings for alarms as necessary.</li></ul></li></ul><ul><li>Following cGMP procedures, retrieve documents from the document management system<ul><li>System: Veeva</li><li>SOP’s: All</li><li>Decision making: Retrieve SOP’s and forms from Veeva.</li></ul></li></ul><ul><li>Complete cGMP documents using good documentation practices<ul><li>System: Veeva, and GMP forms</li><li>SOP’s: VV-QUAL-40763</li><li>Decision making: Follow VV-QUAL-40763 for good documentation practices</li></ul></li></ul><ul><li>Monitor the cycle count program, activities and results to identify necessary recounts and processes to be monitored and provide updates to senior management<ul><li>System: Oracle, Veeva </li><li>SOP-0830</li><li>Decision making: Cycle count inventory based on material class, record any discrepancies on SOP-0830A form, notify management if a 5% discrepancy per lot is noted during cycle count, adjust in Oracle after cycle count is complete and signed off by management</li></ul></li></ul><ul><li>Help to develop shipment schedule and prepare and transact all Clinical, Commercial product and sample shipments<ul><li>System: Oracle, Veeva,</li><li>SOPs: SOP-0964, SOP-1280</li><li>Decision making: Coordinate deliveries with Cambridge, Liden Center, and Fan Pier sites. Ensure driver knows where and when to deliver, print out pending SOP-0964C requests and run availability in Oracle, transact all pick slip when material has been picked and verified</li></ul></li></ul><ul><li>Coordinate and participate in on-call program to provide emergency coverage in the event of asset outage or other unplanned events. </li><li>Manage min/max inventory levels<ul><li>System: Oracle, Veeva </li><li>Sop’s: SOP-0964</li><li>Decision making: Run min max report in Oracle daily, fill out SOP-0964C form and request items below the min level, coordinate with distribution center on delivery date and time, escalate emergency requests to management</li></ul></li></ul><ul><li>Assess expiry<ul><li>System: Oracle</li><li>SOP’s: SOP-0964</li><li>Decision making run report in Oracle monthly, obtain planning approval on items that can be discarded, coordinate with EH&S on waste disposal</li></ul></li></ul><ul><li>Procure, inventory, and handling of bulk gases<ul><li>System: Coupa, Oracle</li><li>SOP’s SOP-0964</li><li>Decision making: Procure gasses in coupa dependent on manufacturing schedule, receive gasses in Oracle and coordinate with QC and QA on release, apply tanks to LN2 stations for cryo tanks, cryo pod filling stations, CRF’s as needed, return empty tanks to air gas.</li></ul></li></ul><ul><li>Kitting material non-MES and MES enabled batches<ul><li>System: Oracle, MES</li><li>SOP’s: SOP-0964</li><li>Decision making: Run move orders depending on production schedule, ensure items are kitted in appropriate bins and labeled as the move order ID, scan material to staging locators and move them physically to the 4th floor. Help with any MES issues with manufacturing.</li></ul></li></ul><ul><li>Gowning and spraying material into clean rooms<ul><li>System: Oracle</li><li>SOP’s: SOP-1214</li><li>Decision Making: Follow SOP-1214 when gowning is required in manufacturing areas, Spray in material for manufacturing and move them into the appropriate suite physically and systematically, ensure all MAL in and pass through area are clean and organized</li></ul></li></ul><ul><li>Oversee day-to-day scheduling and coordination of daily material deliveries to external Vertex sites. Utilize Oracle to complete requests for materials and subsequent deliveries. Ensure materials are shipped in correct conditions.</li><li>Train employees in supply chain basics</li><li>Advise as needed on processes/procedures within the materials management department, including GMP raw materials, inventory control, cell bank storage, product shipments and ERP stability</li><li>May represent Supply Chain department on assigned project sub-teams and/or task forces as a key support resource; may help execute supply chain production activities</li><li>Safely operate all motorized equipment including forklift trucks, electric pallet jacks, lifts, and company vehicles.</li></ul>Keys to Success: Education High school diploma or secondary school diploma.Experience Typically requires 4 years of experience or the equivalent combination of education and experienceKnowledge, Skills, Abilities "Can-do" Attitude.Experience in a materials management, supply chain, or manufacturing roleExperience in pharmaceutical industryExperience working in a cGMP environmentExperienced in ERP transactions regarding cGMP raw materials, inventory control, shipment processing and reportingAnalytical, problem solving and critical thinking skills to address atypical process/procedure deviationsAbility to use a computer and knowledge of some Microsoft Office products (i.e., Word, Excel, PowerPoint)Must be proficient in the use of the inventory management system (ERP) and execute real time transactions such as material transfers, inventory reporting, inventory reconciliation/investigations, order shipping confirmations, and cycle countingAttention to detail when performing and verifying daily activitiesKnowledge of good documentation practices, ability to follow procedures as written, and train/mentor junior associatesPhysical Requirements / Work Environment The role primarily involves working independently at customer sites, which may include areas with chemical-based allergens like penicillin and tetracycline. Personal protective equipment, such as lab coats, coveralls, facemasks, and steel-toe shoes, is often required. The position requires regular lifting of 30-40 lbs (up to 50 lbs occasionally) and using equipment like pushcarts and forklifts to move up to 100 lbs. Standing, walking, and manual material handling are frequent activities, sometimes in varied temperature environments. Overtime work may also be necessary. Pre-employment RequirementsAs a condition of employment with Thermo Fisher Scientific, you must successfully complete and satisfy Thermo Fisher’s pre-employment screening (including background check and drug test) and any customer-mandated screening, credentialing, or badging requirements. Customer requirements may differ from or exceed Thermo Fisher’s criteria.Benefits We offer comprehensive healthcare, paid Holidays, tuition reimbursement, and a range of employee benefits. Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects. We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation! Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory at Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued. Apply today! http://jobs.thermofisher.com 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. Accessibility/Disability Access Job Seekers with a Disability: Thermo Fisher Scientific offers accessibility service for job seekers requiring accommodations in the job application process. For example, this may include individuals requiring assistance because of hearing, vision, mobility, or cognitive impairments. If you are a job seeker with a disability, or assisting a person with a disability, and require accessibility assistance or an accommodation to apply for one of our jobs, please submit a request by telephone at 1-855-471-2255*. Please include your contact information and specific details about your required accommodation to support you during the job application process. *This telephone line is reserved solely for job seekers with disabilities requiring accessibility assistance or an accommodation in the job application process. Messages left for other purposes, such as not being able to get into the career website, following up on an application, or other non-disability related technical issues will not receive a response. </div></div>Compensation and BenefitsThe hourly pay range estimated for this position based in Massachusetts is $24.32–$31.90.This position may also be eligible to receive a variable annual bonus based on company, team, and/or individual performance results in accordance with company policy. We offer a comprehensive Total Rewards package that our U.S. colleagues and their families can count on, which includes:<ul><li>A choice of national medical and dental plans, and a national vision plan, including health incentive programs</li><li>Employee assistance and family support programs, including commuter benefits and tuition reimbursement</li><li>At least 120 hours paid time off (PTO), 10 paid holidays annually, paid parental leave (3 weeks for bonding and 8 weeks for caregiver leave), accident and life insurance, and short- and long-term disability in accordance with company policy</li><li>Retirement and savings programs, such as our competitive 401(k) U.S. retirement savings plan</li><li>Employees’ Stock Purchase Plan (ESPP) offers eligible colleagues the opportunity to purchase company stock at a discount</li></ul>For more information on our benefits, please visit: <a href="https://jobs.thermofisher.com/global/en/total-rewards" target="_blank">https://jobs.thermofisher.com/global/en/total-rewards</a>