IT QA Specialist Healthcare Financial, Inc.IT QA SpecialistQuincy, MA$85,000–$100,000 / yearFull timeWorking alongside developers, business analysts, and project teams, you'll identify issues early, validate solutions, and help deliver high-quality software releases. We're looking for an IT QA Specialist who is passionate about quality, enjoys solving complex technical challenges, and takes pride in ensuring software performs as expected before it reaches production.
NewSecurity Installation Specialist JobotSecurity Installation SpecialistBoston, MA$40–$52 / hourInformation collected and processed as part of your Jobot candidate profile, and any job applications, resumes, or other information you choose to submit is subject to Jobot's Privacy Policy, as well as the Jobot California Worker Privacy Notice and Jobot Notice Regarding Automated Employment Decision Tools which are available at jobot.com/legal. From AI-powered IP video surveillance to cloud-connected access control, you’ll help deploy security platforms that power some of the most advanced hospitals, data centers, universities, and industrial facilities in the country.
NewMRO Specialist JobotMRO SpecialistCanton, MA$35–$40 / hourOur client was founded over 115 years ago and based in Canton, MA, with additional U.S. operations across the country and a global footprint spanning 103 countries and more than 400 factories, we are a worldwide innovation and sustainability leader in specialty chemicals — developing and producing systems and products for bonding, sealing, damping, reinforcing, and protecting in commercial and residential construction, as well as the transportation, marine, automotive, and renewable energy industries. With approximately 33,000 employees worldwide and CHF 11.20 billion in 2025 sales, we foster a culture of entrepreneurship, safety, open communication, and social responsibility — empowering every team member to make decisions, grow their career, and contribute to a more sustainable future.
NewContracts and Compliance Specialist GCR Professional ServicesContracts and Compliance SpecialistAyer, Massachusetts$98,000–$100,000 / yearThe Contracts & Compliance Specialist will manage the full lifecycle of government and commercial contracts while ensuring compliance with FAR, DFARS, ITAR, and other applicable regulations. This role is critical to minimizing risk, maintaining contractual integrity, and supporting operations within a highly regulated environment.
NewSales Support Specialist MassMutualSales Support SpecialistBoston, MAThe Internal Sales Desk at MMSD works with distributors in the third-party/independent/national broker-dealer/bank market to sell our fixed and variable annuity products through financial professionals. In this role you will provide telephonic sales support to Financial Professionals regarding MassMutual annuity products, using a variety of tools, including product illustration software and internal sites.
Equipment Specialist, Senior - Secret DCS CorporationEquipment Specialist, Senior - SecretBedford, MA$90,220–$130,000 / yearSupport configuration control by processing, tracking, and recommending dispositions for change notices, ecps, deviation/waiver requests, service bulletins, deficiency reports, Airworthiness Directive Notes, and qcps. Provide integrated logistics support, including provisioning, source coding, maintenance data collection, configuration management data, QDR analysis, and identifying alternate sources of supply for DMS/MS issues.
NewAdministrative Support Specialist, Senior - Secret DCS CorporationAdministrative Support Specialist, Senior - SecretBedford, MA$73,160–$96,000 / yearIn this Advisory and Assistance Services (A&AS) role, you will provide expert-level support to Department of Defense (DoD) programs by assisting government leadership with decision-making, planning, and execution throughout the acquisition lifecycle. The Electronic Systems System (ESS) Division aka Force Protection Division's mission responsibility is to manage and execute the modernization, design, development, testing, fielding, and sustainment of the various software and hardware within the ESS Portfolio.
NewAdministrative Support Specialist, Journeyman - Secret DCS CorporationAdministrative Support Specialist, Journeyman - SecretBedford, MA$60,467–$70,000 / yearThis role requires strong organizational skills, attention to detail, and the ability to manage multiple priorities while ensuring seamless administrative and operational support for leadership and program staff. This is a full-time position located at Hanscom AFB, MA supporting the Interoperable Air and Missile Defense Branch (HBNI) of the International Command & Control and Sensors Division (AFLCMC/HBN).
MDS Specialist Care-OneMDS SpecialistBrookline, MAThe MDS/Clinical Reimbursement Coordinator will be responsible for, but not limited to: Direct the Resident Assessment Process through assisting with the completion of the Minimum Data Set (MDS) and CAA's. Participate in developing individualized resident Care Plans, identifying the needs of the resident and projected outcomes as required by Federal and State regulations.
NewMDS Specialist RN Care-OneMDS Specialist RNPeabody, MA$93,000–$99,000 / yearThe MDS/Clinical Reimbursement Coordinator will be responsible for, but not limited to: Direct the Resident Assessment Process through assisting with the completion of the Minimum Data Set (MDS) and CAA's. Participate in developing individualized resident Care Plans, identifying the needs of the resident and projected outcomes as required by Federal and State regulations.
Plant Care Specialist / Horticulturist Vaco LLCPlant Care Specialist / HorticulturistBoston, MA$62,000–$75,000 / yearDetermining compensation for this role (and others) at Vaco by Highspring depends upon a wide array of factors including but not limited to: the individual’s skill sets, experience and training; licensure and certification requirements; office location and other geographic considerations; other business and organizational needs. Determining compensation for this role (and others) at Vaco/Highspring depends upon a wide array of factors including but not limited to the individual’s skill sets, experience and training, licensure and certifications, office location and other geographic considerations, as well as other business and organizational needs.
Payroll Specialist Vaco LLCPayroll SpecialistRockland, MA$70,000–$100,000 / yearDetermining compensation for this role (and others) at Vaco by Highspring depends upon a wide array of factors including but not limited to: the individual’s skill sets, experience and training; licensure and certification requirements; office location and other geographic considerations; other business and organizational needs. Determining compensation for this role (and others) at Vaco/Highspring depends upon a wide array of factors including but not limited to the individual’s skill sets, experience and training, licensure and certifications, office location and other geographic considerations, as well as other business and organizational needs.
Collections Specialist Vaco LLCCollections SpecialistBoston, MA$95,000–$115,000 / yearDetermining compensation for this role (and others) at Vaco by Highspring depends upon a wide array of factors including but not limited to: the individual’s skill sets, experience and training; licensure and certification requirements; office location and other geographic considerations; other business and organizational needs. Determining compensation for this role (and others) at Vaco/Highspring depends upon a wide array of factors including but not limited to the individual’s skill sets, experience and training, licensure and certifications, office location and other geographic considerations, as well as other business and organizational needs.
Accounts Receivable Specialist Vaco LLCAccounts Receivable SpecialistDedham, MA$52,000–$59,000 / yearDetermining compensation for this role (and others) at Vaco by Highspring depends upon a wide array of factors including but not limited to: the individual’s skill sets, experience and training; licensure and certification requirements; office location and other geographic considerations; other business and organizational needs. Determining compensation for this role (and others) at Vaco/Highspring depends upon a wide array of factors including but not limited to the individual’s skill sets, experience and training, licensure and certifications, office location and other geographic considerations, as well as other business and organizational needs.
Accounts Payable Specialist Vaco LLCAccounts Payable SpecialistSalem, NH$52,000–$60,320 / yearDetermining compensation for this role (and others) at Vaco by Highspring depends upon a wide array of factors including but not limited to: the individual’s skill sets, experience and training; licensure and certification requirements; office location and other geographic considerations; other business and organizational needs. Determining compensation for this role (and others) at Vaco/Highspring depends upon a wide array of factors including but not limited to the individual’s skill sets, experience and training, licensure and certifications, office location and other geographic considerations, as well as other business and organizational needs.
NewSpecialist Director, Managed Security Testing KPMGSpecialist Director, Managed Security TestingBoston, MA$169,005–$370,530 / yearIf you're looking for a firm with a strong team connection where you can be your whole self, have an impact, advance your skills, deepen your experiences, and have the flexibility and access to constantly find new areas of inspiration and expand your capabilities, then consider a career in Advisory. These include the duties and responsibilities listed above, as well as the abilities to adhere to company policies, exercise sound judgment, effectively manage stress and work safely and respectfully with others, exhibit trustworthiness, and safeguard business operations and company reputation.
NewReal Estate Accounting Specialist CFSReal Estate Accounting SpecialistCambridge, MA$75,000–$85,000 / yearCreative Financial Staffing has partnered with a growing real estate investment and management firm in Cambridge on their search for a Real Estate Accounting Specialist . This is an excellent opportunity for an accounting professional with real estate experience to take ownership of key AP and AR functions while joining a stable, collaborative team during an exciting period of portfolio growth.
Hardware Applications Managment Technical Specialist, Applied Automation Amazon.com Services LLCHardware Applications Managment Technical Specialist, Applied AutomationNorth Reading, MAThe candidate should be open to new challenges, strong at multi tasking, innovative, creative, self directed and a great team player who drives continuous process improvement and partners effectively with cross functional operational and development teams to solve problems and implement new solutions. This position is accountable for the planning and execution of hardware development projects within larger programs while serving as the hardware technical management specialist and coordination lead between Amazon Robotics System teams, Deployment Engineering, Supply Chain, Global Support Services, and our fulfillment and logistics customers.
NewPayroll & Benefits Specialist CFSPayroll & Benefits SpecialistCambridge, MA$60,000–$90,000 / yearPayroll & Benefits Specialist Responsibilities: • Process payroll for approximately 165 employees, primarily in Massachusetts. • Highly visible Payroll & Benefits Administration Specialist role with broad exposure across payroll and benefits.
NewAccounts Payable Specialist CFSAccounts Payable SpecialistHaverhill, MA$50,000–$54,000 / yearCreative Financial Staffing is partnered with a distribution company located in Haverhill, MA to identify an Accounts Payable Specialist. No peaks or valleys throughout the year--always an 8-5 with no expected overtime and summer Fridays.
NewTechnology Operations and Support Specialist CFSTechnology Operations and Support SpecialistWellesley, MA$35–$42 / hourA mission-driven K–8 school is seeking a Technology Operations & Support Specialist to serve as the primary on-site IT resource supporting ~190 students and 75+ faculty/staff in a Mac-based , Google Workspace environment. This is a part-time (30 hrs/week), highly visible role requiring strong hands-on support experience and a collaborative, service-first mindset.
NewFacilities Specialist SymboticFacilities SpecialistNorth Reading, MA$29.81–$41.25Applying next-gen technology, high-density storage and machine learning to solve today's complex distribution challenges, Symbotic enables companies to move goods with unmatched speed, agility, accuracy and efficiency. As the Facilities Specialist, you will oversee the daily operations, maintenance, and security of the facility, ensuring buildings, grounds, and equipment are safe, compliant, and operating efficiently.
Travel NICU Respiratory Therapist - ECMO Specialist - $2,767 per week American TravelerTravel NICU Respiratory Therapist - ECMO Specialist - $2,767 per weekBoston, MAAmerican Traveler is seeking a Registered Respiratory Therapist (RRT) for a hybrid RRT/ECMO Specialist role in a NICU at a leading children's hospital in Boston, requiring prior travel experience and centrifugal ECMO proficiency. With thousands of travel nursing and allied jobs nationwide, our attentive and approachable recruiters find positions that align perfectly with your career aspirations and personal requirements.
NewActivities Specialist - COTA Element CareActivities Specialist - COTABrighton, MA$28.85–$35.10 / hourIncumbent assists the Manager of Habilitation and Activities by delivering programs and activities that will support habilitation, wellness and recreation at Adult Day Health sites, in participants’ homes and via telehealth. Under the supervision of the Manager of Habilitation and Activities, this individual is responsible for completing a comprehensive assessment and providing an individualized treatment plan in accordance with each participant’s physical, social, emotional, and spiritual needs.
NewRespiratory Therapist Ventilator Patient Specialist Rotech Healthcare Inc.Respiratory Therapist Ventilator Patient SpecialistMethuen, MA$45–$50 / hourValid driver's license in state of residence with a clean driving record (when applicable for the position)Education and/or Experience Completion of an accredited program/degree in respiratory care preferred; nursing (RN) may be acceptable depending upon state licensure laws. Required to comply with Rotech Respiratory Protection & N95 Mask Fit Testing Policy Medical Evaluation and Fit Testing Compliance in a timely mannerAnnual RecertificationKeep face clean-shaven to ensure N95 Mask face-seal protection per OSHA guidelines.
NewSpecialist, Quality Engineering L3Harris TechnologiesSpecialist, Quality EngineeringCarlisle, MA$84,000–$156,000 / yearIn lieu of a degree, minimum of 8 years of prior related experience 2 years of experience with Material Review Board and Review of Mechanical drawings Ability to obtain security clearance Preferred Additional Skills: RCCA DOE experience Experience working with multi-functional teams (Engineering, Supply Chain, Operations) In-depth knowledge of project management In compliance with pay transparency requirements, the salary range for this role in Massachusetts is $84,000 - $156,000. Our business built telescopes that took the first close-up pictures of Pluto in support of NASA’s New Horizons program ( https://www.nasa.gov/mission_pages/newhorizons/images/index.html ) and created the first laser communication device outside the Earth-Moon system ( Deep Space Optical Communications (DSOC) - NASA ).
2026-2027 Library Information Specialist (Librarian) LIS Applicant Pool @ Instruction Department Alief Independent School District2026-2027 Library Information Specialist (Librarian) LIS Applicant Pool @ Instruction DepartmentMA2026-2027 Library Information Specialist (Librarian) LIS Applicant Pool @ Instruction Department - Alief Independent School District.
Disability Rights Information Specialist Commonwealth of MassachusettsDisability Rights Information SpecialistBoston, MA$65,578.50–$94,378.44 / yearProgram Coordinator I'',''Program Coordinator I'',''United States-Massachusetts-Boston-1 Ashburton Place'',''United States-Massachusetts-Boston-1 Ashburton Place'',''Administrative Services'',''Administrative Services'',''Massachusetts Office On Disability'',''Massachusetts Office On Disability'',''Full-time'',''Full-time'',''Day'',''Day'',''Jun 1, 2026, 6:45:05 PM'',''Jun 1, 2026, 6:45:05 PM'',''1'',''1'',''3,629.94'',''2,522.25'',''3,629.94'',''Biweekly'',''Meighan MINIMUM ENTRANCE REQUIREMENTS: Applicants must have at least (A) two years of full-time, or equivalent part-time, professional, administrative or managerial experience in business administration, business management or public administration the major duties of which involved program management, program administration, program coordination, program planning and/or program analysis, or (B) any equivalent combination of the required experience and the substitutions below.
Health Information Specialist I Datavant LLCHealth Information Specialist IBoston, MA$15–$18.32 / hourGuided by our mission to make the world's health data secure, accessible and actionable, we provide critical data solutions for organizations across the healthcare ecosystem - including providers, health plans, researchers, and life sciences companies. From fulfilling a single patient's request for their medical records to powering the AI revolution in healthcare, Datavanters are building the future of how data is connected and used to improve health.
Information Specialist SercoInformation SpecialistBoston, MARemoteActual base salary will be determined by a variety of factors, including but not limited to, the scope of the role, relevant experience, job-related knowledge, education and training, key skills, and geographic market considerations. Eligible employees also gain access to a wide range of benefits from comprehensive health coverage and health savings accounts to retirement plans, life and disability insurance, and time-off programs that support work-life balance.
Health Information Specialist I DatavantHealth Information Specialist IBoston, MA$15–$18.32 / hourGuided by our mission to make the world's health data secure, accessible and actionable, we provide critical data solutions for organizations across the healthcare ecosystem - including providers, health plans, researchers, and life sciences companies. From fulfilling a single patient's request for their medical records to powering the AI revolution in healthcare, Datavanters are building the future of how data is connected and used to improve health.
Health Information Specialist I - Worcester, MA Datavant LLCHealth Information Specialist I - Worcester, MAWorcester, MA$15.76–$19.24 / hourThis is an entry level position responsible for processing all release of information (ROI), specifically medical record requests, in a timely and efficient manner ensuring accuracy and providing customers with the highest quality product and customer service. Guided by our mission to make the world's health data secure, accessible and actionable, we provide critical data solutions for organizations across the healthcare ecosystem - including providers, health plans, researchers, and life sciences companies.
Health Information Specialist DatavantHealth Information SpecialistNashua, NHThis position is responsible for processing all release of information (ROI) specifically medical record requests in a timely and efficient manner ensuring accuracy and providing customers with the highest quality product and customer service. Guided by our mission to make the world's health data secure, accessible and actionable, we provide critical data solutions for organizations across the healthcare ecosystem - including providers, health plans, researchers, and life sciences companies.
Health Information Technology Specialist East IQVIA Holdings IncHealth Information Technology Specialist EastBoston, MA$125,000–$135,000 / yearThe primary focus of this role will be to support integration of the brand into EHR systems across priority accounts, helping identify and address barriers that affect patient care, access, treatment processes, patient identification, and overall end-user experience In addition, the Health IT Specialist will be responsible for sharing Electronic Health Record insights to enhance patient care and support population health approaches across both in-patient and outpatient sites of care at priority accounts. Bachelor's degree from an accredited college/university required; Minimum of 4 years working in design, build, and/or testing expertise and experience with EHR software, including: Epic, Cerner, Meditech, McKesson preferred; and/or within a Health System informatics group or team at leadership level, or similar role within a pharmaceutical company.
Law Enforcement Information Specialist City of QuincyLaw Enforcement Information SpecialistQuincy, MAAnswering 911 calls, coordinating and dispatching any necessary response, and entering all data necessary to complete the computer-aided-dispatch system (CAD); Answering and routing business calls to the Quincy Police Department; Entering the police roster into CAD at the beginning of each shift; Arranging for the towing of vehicles and recording the information in CAD; Entering restraining orders into the restraining order tracking file system, checking for warrants and firearm ownership, and scheduling the call for service of the restraining order. Generating and distributing CAD journals to various police division heads; Entering missing persons reports into the NCIC as required by federal regulations; Sending, receiving, and interpreting teletype messages from other law enforcement agencies; Entering stolen vehicles, plates, firearms, boats, etc.
Senior Quality Information Systems Specialist Ardelyx IncSenior Quality Information Systems SpecialistWaltham, MA$145,000–$177,000 / yearThe Senior Specialist partners with cross-functional teams to assess risk, support system validation efforts, and ensure audit readiness across IT systems and projects. Position Summary: The Senior Quality Information Systems Specialist is responsible for supporting IT compliance, risk management, and computer systems validation activities within a regulated life sciences environment.
Information Technology Specialist- Eataly Boston and Eataly Dallas Eataly Net USA LLCInformation Technology Specialist- Eataly Boston and Eataly DallasBoston, MA$25–$30 / hourAs a senior member of Eataly's Information Technology (IT) team, the IT Specialist is primarily responsible for evaluating and implementing IT strategy and solutions for several Eataly USA locations (stores and Corporate office), and for providing advice to upper-level management about Eataly's IT needs and structure. Advises management regarding and supports IT infrastructure and other needs for several Eataly USA locations (stores and Corporate office).
Lead Health Information Management Audit Specialist (On-Site) Lahey Hospital and Medical CenterLead Health Information Management Audit Specialist (On-Site)Burlington, MA$21–$28.26 / hourUnder direction from the Manager, Health Information Management, a Lead Health Information Management Audit Specialist collaborates closely with other departments/teams to provide efficient and thorough healthcare claims auditing requirements for Beth Israel Lahey Health (BILH) and its affiliates. Researches cases, transfers documentation to electronic media, updates the intra-departmental database, communicates issues and findings to the Director of Internal Audit/Compliance, Director of Case Management, and Coding Manager as appropriate.
Senior Quality Information Systems Specialist - IT Ardelyx, Inc.Senior Quality Information Systems Specialist - ITWaltham, MA$145,000–$177,000 / yearThe Senior Specialist partners with cross-functional teams to assess risk, support system validation efforts, and ensure audit readiness across IT systems and projects. Position Summary: The Senior Quality Information Systems Specialist is responsible for supporting IT compliance, risk management, and computer systems validation activities within a regulated life sciences environment.
Information Security Admin Specialist - Senior Associate State Street CorpInformation Security Admin Specialist - Senior AssociateQuincy, MA$52,000–$91,000 / yearAs an essential partner in our shared success, you'll benefit from inclusive development opportunities, flexible work-life support, paid volunteer days, and vibrant employee networks that keep you connected to what matters most. Support various client-facing applications, set up, training and resolving data integrity issues within specific timeframes.
Digital Learning Specialist (2026-2027) NORTH READING PUBLIC SCHOOL DISTRICTDigital Learning Specialist (2026-2027)MAThe North Reading Public Schools (NRPS) provides a safe, inclusive, and supportive learning environment where students develop both their social-emotional and academic skills and abilities through an exploration of a wide range of content areas, the arts, athletics, and extra-curricular opportunities. Candidates with different perspectives and experiences are strongly encouraged to apply to grow our school community and help students feel personally connected to their learning experiences and feel represented inside and outside of the classroom ensuring a sense of belonging.
NewTraining Specialist Position Integrated Resources, IncTraining Specialist PositionLexington, MassachusettsContractorTraining Methods may include one of the following:Read and understandKnowledge checksE-Learning (WBT)Instructor Led Training (ILT)On the Job Training (OJT)35% Partner with functional area subject matter experts to develop Training Guides for On-the-job training (OJT), for use in Quality functions. Job DescriptionResponsibilities:This role will support the identification and development of training for the Tech Ops Quality Organization Including Quality functions such as Quality Control and Quality Assurance.50% Collaborate with functional area subject matter experts (SMEs) to identify the appropriate training method for the content.
NewClinical Document Management Specialist Integrated Resources, IncClinical Document Management SpecialistLexington, MassachusettsContractorResponsibilities70% Responsible for high quality clinical document deliverables across multiple, global assigned studies in support of GCDO ensuring effective lifecycle management of the clinical section of the TMF.• Key contributor and member of the clinical study team• Monitors completeness and quality of the Clinical TMF, including elements outsourced to CRO• Ensures effective communication and issue escalation internally and with external vendors• Oversees consolidation and archive preparation of clinical TMF, liaising with CRO partners to ensure compliance with company SOPs and timelines throughout the process.• Ensures compilation of CSR appendices in accordance with Shire's process20% Supports inspection readiness for GCDO through periodic quality assessment of clinical records.• Supports assigned TMF corrective action plans under direction of Senior CDM/Manager.10% Supports CDM initiatives to enhance efficiencies in document management practicesQualificationsEducation and Experience Requirements• Minimum 2 years of pharmaceutical industry experience• Records management/TMF experience• Familiarity with various aspects of clinical trials and regulatory submissions.
NewQA/QC Specialist III Integrated Resources, IncQA/QC Specialist IIILexington, MassachusettsContractorProvide QA guidance/review/approval for Product Development projects in Phase 1 to Phase 3.• Oversee appropriate Quality Systems appropriate for Clinical Phase Materials.• QA Contact for applicable Quality Systems related to R&D.• Review and approved: Master Batch Records, executed batch records, deviations, CAPA and change controls.• Responsibilities• Support of Clinical Operations including Drug Substance, Bulk Drug Product Manufacture, Clinical Packaging & Labeling and oversight of Clinical CMOs and Distributers• Reviewing QC data and COA approval.•
NewCommunications Specialist Integrated Resources, IncCommunications SpecialistLexington, MassachusettsContractorJob DescriptionThe Senior Communications Specialist provides communications support and expertise across a variety of channels to increase awareness of IT strategy, partnerships and programs both within IT and throughout the global Shire community. Communications SpecialistA Few Words About Us - Integrated Resources, Inc is a premier staffing firm recognized as one of the tri-states most well-respected professional specialty firms.
NewLogistics Specialist Integrated Resources, IncLogistics SpecialistCambridge, MassachusettsContractorPrimary activities include:developing and maintaining shipping schedules,creation and review of transport documentation,coordination of shipments with company's sites, contracted partner sites, transportation partners and brokers and entry of related deviations. Accountabilities:Shipment coordination: create internal orders or AT's to initiate shipments, create transport documents, set shipment up with transport provider, transport reviews, liaise with brokers and customs agencies as required.
NewQA/QC Specialist I Integrated Resources, IncQA/QC Specialist ILexington, MassachusettsContractorJob DescriptionPosition Details:Location Lexington, MAJob Title QA/QC Specialist 1Duration 6+ MonthsJob Function and Description:To provide QA support for the manufacture, packaging and control of clinical trial materials to ensure compliance with GMP and perform GMP release of IMP and to ensure compliance with market regulations. QA/QC Specialist IA Few Words About Us Integrated Resources, Inc is a premier staffing firm recognized as one of the tri-states most well-respected professional specialty firms.
NewClinical Document Management Specialist IV Integrated Resources, IncClinical Document Management Specialist IVLexington, MassachusettsContractorJob DescriptionNOTE:TMF BackgroundPharma Industry experience (couple of years) Clinical Trial Experience (few years) GCP Experience (few years) Not senior level experience (doesn't need a decade worth of experience) Bachelor's degree requiredDay to day Mtg of TMF-early planning and setup all the way to study closeout and performing of consolations and archival activitiesFocusing on TMF lifecycle as a whole TMF assigned specific trials to work on Day to day activities include:QC of documents (paper and electronic)Team meetings (communicating issues to CTA/CRA) FilingJOB DESCRIPTION:Reporting to the Clinical Documentation Team Lead, and working in collaboration with the clinical study teams, the Clinical Document Management Specialist (CDMS) is responsible for the management and oversight of Trial Master File (TMF) records from set-up through to final archival of the clinical trial, ensuring compliance with company SOPs and processes, and all applicable regulations. Current awareness of regulatory requirements for clinical trials (ICH/GCP).Associates/Bachelor's degree or equivalent preferredKey Skills, Abilities, and CompetenciesSufficient knowledge of regulatory requirements and ICH-GCP guidelines to support records managementDemonstrated ability to work independently, take initiative, complete tasks to deadlinesRequires strong attention to detail, document organization skills, establishing priorities, scheduling and meeting deadlinesSolid communication skills and strong customer focus with ability to interact in a global, cross functional organizationAbility to communicate effectively with external vendors, including issue escalation, and responding to enquiries and concernsMust be able to work in a fast paced environment with demonstrated ability to prioritize multiple competing tasks and demands.
NewDevelopment Specialist II Integrated Resources, IncDevelopment Specialist IILexington, MassachusettsContractorJob DescriptionPosition Details:Client Direct ClientLocation Lexington, MAJob Title Development Specialist IIDuration 6+ MonthsMust have skill-set [Job Description] Job SummaryThis individual will contribute to purification process development. Experience in protein analytical methods, including ELISA, HPLC, enzymatic assays, SDS-PAGE and Western Blot.• Demonstrated capability of high quality work and keen attention to detail.•
NewQA Specialist IV Integrated Resources, IncQA Specialist IVLexington, MassachusettsFull timeResponsibilities-This position is responsible for monitoring and supporting batch disposition of bulk drug products (DP) and finished drug products (FDP)The individual may be responsible for, but is not limited to: Conducting record review of executed batch records for finish drug products to support CMO packaging & labeling record reviewPerforming review of bulk drug product executed records, if neededPrepares all paper work for product disposition (bulk and finished product) and performed assessments for impact to disposition from deviations and change controlsReviews and approve deviations and change controls related to DP and FDPMay own CAPAs associated within the QA unitSupports drug product and finish drug product annual review report sectionsUnderstanding of GMP'sSupports departmental projects as neededQualificationsBachelor's degree in chemistry, biology or a related discipline6-8 years Quality Assurance experience supporting the manufacture and/or release of drugs, biologics, or devices at CMOsWorking knowledge of DP and FDP batch record reviewUnderstanding of quality systems and cGMPs. Interpersonal skills and professional skills to interact with customersMust be flexibleMust be able to prioritize and multitask in a stressful environmentFluency in English is requiredSignificant experience in parenteral biotech manufacturing (aseptic or sterile processing)Significant experience working with suppliers and/or contract manufacturing organizationsExperience with TrackWise and LIMS systemsExperience with packaging and labeling operationsEvaluation of batches to ensure completeness, accuracy and complianceEvaluation of manufacturing or operational issues for impact and communication to management.