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Integration International jobs in Cambridge, MA - 161 jobs

  • CSR Planner

    Integration International Inc. 4.1company rating

    Integration International Inc. job in Foxborough, MA

    Job Details: Job Title: CSR Planner Pay Rate: $25-$27/hour (W2, No Benefits) - based on experience Schedule: 1st Shift | 7:30 AM - 4:00 PM Duration: 1-Year Contract with Potential for Permanent Conversion About the Role: We are hiring a CSR Planner to join a highly technical, engineering-driven manufacturing plant specializing in instrumentation materials. This role is based onsite in Foxborough, MA, and supports a close-knit team of approximately 20 professionals across Customer Service, Planning, and Purchasing. You'll work in a diverse, collaborative environment where teamwork is encouraged, ideas are valued, and everyone has the opportunity to contribute to team discussions and process improvement initiatives. This role is ideal for someone seeking career growth, upward mobility, and hands-on experience within a complex manufacturing operation. Periodic travel may be available for training opportunities. Key Responsibilities: Enter and manage customer orders, interpret requests, and assign work to appropriate team members. Serve as a liaison between internal teams and external customers, coordinating with manufacturing, sales, distribution, and field service. Handle customer inquiries and complaints related to order status, production, delivery, and billing in a timely and accurate manner. Perform order processing, error correction, and maintenance for order-based and proposal-based requests. Coordinate product selection, order placement, delivery schedules, and expediting with customers. Proactively resolve customer issues to strengthen relationships and drive positive feedback. Provide product information, including limited technical details when required. Maintain and update data across systems such as SAP, Quote-to-Cash, Salesforce, Buy Automation, shared drives, and external portals. Qualifications: No degree required. Strong verbal and written communication skills. Ability to prioritize work, meet deadlines, and work independently in a fast-paced environment. Proven ability to build and maintain effective working relationships with internal and external partners. Strong mediation, negotiation, and facilitation skills. Working knowledge of Microsoft Windows and standard business applications (Word, Excel, Access). Experience using Salesforce is preferred. SAP experience is a plus. Why Consider This Role? Engineering-focused manufacturing environment. Collaborative and diverse team culture. Opportunity to grow skills and advance within the organization. Potential for permanent conversion. If you enjoy customer interaction, thrive in a manufacturing or engineering setting, and are eager to grow your career, we'd love to hear from you.
    $25-27 hourly 3d ago
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  • desktop support

    Artech Information System 4.8company rating

    Boston, MA job

    Artech is the 10th Largest IT Staffing Company in the US, according to Staffing Industry Analysts' 2012 annual report. Artech provides technical expertise to fill gaps in clients' immediate skill-sets availability, deliver emerging technology skill-sets, refresh existing skill base, allow for flexibility in project planning and execution phases, and provide budgeting/financial flexibility by offering contingent labor as a variable cost. Job Description ROLE :Desktop Support LOCATION: Boston,MA Duration:12 month+ Deskside Break/Fix troubleshooting and solutioning experience in larger corporate environments. The support platform is Microsoft OS including Win7 and some Win10 (piloting). In addition there is a need for some current MAC OS support (corporate environment) including OS troubleshooting, imaging, and builds. The candidate must also be able to support Mobility Devices (phone and tablet) of multiple platforms including Apple, Android, and Microsoft. This position requires solid experience in application support of standard Microsoft Office products current through Office 365, including support of Outlook/Exchange in a corporate environment across PC, phone, and tablet devices. The candidate must be able to provide onsite and remote support of high level and executive end users through the use of in person, phone, and Remote Takeover tools. Superior Customer Service skills are essential and the candidate must have outstanding communication skills both verbal and written. Additional Information For more information, Please contact Shubham ************
    $51k-69k yearly est. 2d ago
  • Research Assistant I

    Artech Information System 4.8company rating

    Framingham, MA job

    Artech is the 10th Largest IT Staffing Company in the US, according to Staffing Industry Analysts' 2012 annual report. Artech provides technical expertise to fill gaps in clients' immediate skill-sets availability, deliver emerging technology skill-sets, refresh existing skill base, allow for flexibility in project planning and execution phases, and provide budgeting/financial flexibility by offering contingent labor as a variable cost. Job Description The Research Assistant will participate in the analysis of protein therapeutics in support of formulation development using established methods, across a variety of technological platforms such as CE, HPLC, CD, DSC, CE-SDS and SDS-PAGE. Key expectations and core training will include pipetting accuracy, sample preparation, dilution and testing of samples using analytical methods. Good communication skills (oral and written). Laboratory notebooks maintenance; compile data for monthly reports, ability to work in a fast pace team environment. Skills: Recent graduates will be considered. Experience in the biotechnology/pharmaceutical industry preferred Qualifications B.S. in biochemistry or related discipline. Additional Information Best Regards, Akriti Gupta ************** Morristown, NJ 07960
    $49k-68k yearly est. 60d+ ago
  • Regulatory Affairs Specialist

    Artech Information System 4.8company rating

    Cambridge, MA job

    Artech is the 10th Largest IT Staffing Company in the US, according to Staffing Industry Analysts' 2012 annual report. Artech provides technical expertise to fill gaps in clients' immediate skill-sets availability, deliver emerging technology skill-sets, refresh existing skill base, allow for flexibility in project planning and execution phases, and provide budgeting/financial flexibility by offering contingent labor as a variable cost. Job Description • The Regulatory Affairs Operations (RA Ops) submission group is organized to provide submission development support to project teams and the regulatory community. The focus of this position will be to publish, submit and maintain regulatory filings in coordination with Global Regulatory Leads. The role works to tight, business-critical deadlines within a highly regulated environment. • She/he also ensures that compliance standards are met for receipt and delivery of information to and from external consultants and health authorities. • Expert in publishing capabilities of all modules with a competency in the component locations within the eCTD backbone structure. • Support Global Regulatory Leads in the planning, development, and publishing of submissions. • Control submission component receipt and workflow completion to ensure a high quality final submission. Ensure that issues are identified at an early date and actively contribute to issue resolution before filing dates are impacted. • Coordinate publishing tasks associated with assigned submissions, including peer review of submissions generated by other publishers. • Ability to contribute to brainstorming and troubleshooting of technical issues that impact validation requirements for submission dispatch. • Dispatch submissions through the FDA Gateway • Ensure adherence to internal and external standards including Standard Operating Procedures, Guidance Documents, and Policies throughout the lifecycle of the application. • Archive submissions both electronic and paper. Skills: • Proficient in use of MS Office, Adobe Professional, Adobe Add-ins, Publishing Software (sCubed and/or eCTD Manager), Validation Tools and Document Management Systems. • Demonstrate ability to function autonomously in a matrix environment. • Knowledgeable in appropriate ICH and FDA regulations pertaining to regulatory and technical requirements for electronic submissions. • Must be detail oriented and articulate with strong analytical, decision-making, and interpersonal • Demonstrate regulatory knowledge and awareness, technical competence, sound judgment, and a professional demeanor. • Demonstrate flexibility in dealing with change and diversity. • Ability to multi-task in a fast paced environment. • All candidates should have an understanding of the concepts around regulatory affairs and significant knowledge of submissions processes. • Proficient in formatting Word documents prior to publishing and electronic navigation for Adobe documents. Education: At least a bachelor s degree, or equivalent, in regulatory affairs, the sciences, or related areas of study, and relevant experience. Four years submission publishing experience . Additional Information Best Regards, Anuj Mehta ************
    $63k-89k yearly est. 2d ago
  • Validation Specialist III

    Artech Information System 4.8company rating

    Boston, MA job

    Artech is the 10th Largest IT Staffing Company in the US, according to Staffing Industry Analysts' 2012 annual report. Artech provides technical expertise to fill gaps in clients' immediate skill-sets availability, deliver emerging technology skill-sets, refresh existing skill base, allow for flexibility in project planning and execution phases, and provide budgeting/financial flexibility by offering contingent labor as a variable cost. Job Description Job Location: Allston, MA (System Correction) QC Instrumentation Services is responsible for the management and implementation of the Laboratory Equipment Qualification system. It's goal to efficiently specify/source laboratory equipment and execute qualifications in a timely manner to enable QC Microbiology and QC Chemistry departments to execute their functions using equipment which meets their needs and intended use. These are some of the responsibilities: Coordinate activities relating to the qualification, calibration and maintenance of laboratory equipment and related systems. Coordinate the purchase, commissioning and introduction to service of new equipment. Establish and maintain Equipment History Files (EHF) for QC laboratory equipment. Be the contact point for instrumentation issues and provide training and troubleshooting support to the laboratory on new or existing instrumentation. Coordinate all services provided by vendors, ensuring vendors meet all site requirements. Schedule/plan/execute validation activities and preventive maintenance of laboratory equipment. Skills: Demonstrated scientific technical writing ability. Knowledge of USP 1058 and GAMP methodology. Knowledge of 21CFR Parts 11, 210, 211, 600 and 610. Experience with Empower and LIMS systems. Previous hands on experience performing laboratory equipment qualification. Proficient in Outlook and Microsoft Word and Excel and lab based data management systems. Ability to gown and enter laboratory May require off shift work to support activities Ability to gown and enter laboratory May require off shift work to support activities Qualifications Bachelor's Degree in Chemistry, Life Sciences, or Engineering discipline and 5 years of Industry relevant experience Or Master's Degree in Chemistry, Life Sciences, or Engineering discipline and 3 years of Industry relevant experience Minimum of 3 years of experience with analytical testing in a laboratory setting, such as HPLC, GC, Ion Chromatography, TOC, UV-Vis, ELISA. Additional Information Best Regards, Akriti Gupta ************** Morristown, NJ 07960
    $85k-116k yearly est. 2d ago
  • Documentation Specialist-I

    Artech Information System 4.8company rating

    Boston, MA job

    Artech is the 10th Largest IT Staffing Company in the US, according to Staffing Industry Analysts' 2012 annual report. Artech provides technical expertise to fill gaps in clients' immediate skill-sets availability, deliver emerging technology skill-sets, refresh existing skill base, allow for flexibility in project planning and execution phases, and provide budgeting/financial flexibility by offering contingent labor as a variable cost. Job Description Tracking and reviewing change control documentation. Assist with the editing of quality documents (SOP's, guidelines, validation master plans, etc.) to ensure compliance with regulatory requirements. Must be able to work quickly with a high degree of accuracy. Must possess sound interpersonal and information gathering skills, being able to relate well to others at all levels throughout the organization and have the ability to work in a team environment, effectively interacting with others. Experience: 1 to 3 years Required Skills: Strong organizational skills Attention to detail Ability to work cross-functionally Ability to organize work to meet deadlines Qualifications Education: High School Diploma and 1-3 years administrative/professional experience Experience with Microsoft Office products Additional Information For more information, Please contact Sneha Shrivastava ************
    $44k-74k yearly est. 2d ago
  • Biology Scientist

    Artech Information System 4.8company rating

    Cambridge, MA job

    Artech is the 10th Largest IT Staffing Company in the US, according to Staffing Industry Analysts' 2012 annual report. Artech provides technical expertise to fill gaps in clients' immediate skill-sets availability, deliver emerging technology skill-sets, refresh existing skill base, allow for flexibility in project planning and execution phases, and provide budgeting/financial flexibility by offering contingent labor as a variable cost. • The purpose of this position is to provide support in evaluating various rodent genetic backgrounds in eliciting robust immune response within GBT. • By performing phenotypic analysis of B cell compartment, deep sequencing of B cell repertoire, and studying antibody responses from immunized rodents, we will be able to understand the utility of these animals in biotherapeutic development. • The incumbent, under the supervision by Pharmaceutical scientist, will be involved in the evaluation of the animals through the use of various immunogens, immunization approaches, and characterization method Specific job description: • Perform phenotypic analysis of lymphocyte compartments of rodents • Perform deep sequencing of B cell repertoire of animals and analyze repertoire diversity pre and post immunization • Immunize rodents using various strategies • Characterize antibodies diversity post immunization • Clone and express desired monoclonal antibodies for further analysis Experience: • Knowledge and work experience in the B cell phenotypic analysis by Flow Cytometry • Knowledge and work experience in hybridoma generation • Knowledge and work experience in rodent primary B cell culture • Knowledge and work experience in Ig cloning from B cell • Knowledge and work experience in affinity purification of polyclonal antibodies • Knowledge and work experience in screening and functional assay development for selecting specific monoclonal antibodies • Work experience in NGS of Ig repertoire • Relevant industrial experience is preferred Specific work plan: a) Perform all aspects of phenotypic analysis of lymphocyte compartments of rodents b) Perform, design and analyze B cell repertoire of rodents by deep sequencing c) Perform and design immunization strategies and generate hybridoma d) Evaluate and characterize immune response and monoclonal antibodies from desired rodents e) Contribute to drafting relevant documentation such as immunization protocols, phenotypic and repertoire analysis reports and laboratory methods. Qualifications Bachelor's degree required Additional Information Best Regards, Anuj Mehta ************
    $66k-96k yearly est. 60d+ ago
  • Regulatory Affairs CMC

    Artech Information System 4.8company rating

    Westborough, MA job

    Artech is the 10th Largest IT Staffing Company in the US, according to Staffing Industry Analysts' 2012 annual report. Artech provides technical expertise to fill gaps in clients' immediate skill-sets availability, deliver emerging technology skill-sets, refresh existing skill base, allow for flexibility in project planning and execution phases, and provide budgeting/financial flexibility by offering contingent labor as a variable cost. Job Description: • Perform general Regulatory Affairs Chemistry Manufacturing and Controls (CMC) work including dossier and document preparation for various commercial and/or development product applications. • Support regulatory activities for the strategies aligned with Health Authority requirements from a global perspective, and supporting the on-time submission of regulatory submissions. • Additional duties may include regulatory compliance administrative support • Coordination with cross functional department personnel from regulatory, quality, and manufacturing sites. • Provide support for other CMC projects and tasks as needed. Qualifications Basic Qualification: - Bachelor's degree with 2 years experience in a Regulatory Affairs related role - Fluency in the understanding and format of the Common Technical Document (CTD) - Authoring experience of CTD Module 2 & Module 3 sections - Excellent writing skills Basic understanding of pharmaceutical manufacturing processes Additional Information Best Regards, Anuj Mehta ************
    $125k-176k yearly est. 60d+ ago
  • Associate QC Scientist

    Artech Information System 4.8company rating

    Devens, MA job

    Support raw material qualifications, method transfers, and validation of assays such as UV-VIS Spectrometry, SDS Page, wet chemical analysis, utility testing (e.g. TOC, conductivity, and gas testing) and more complex assays including GC solvent analysis and various HPLC methodologies (e.g. peptide map and carbohydrate analysis). Review compendial methods (USP, EP, JP) for alignment with internal raw material test procedures and specifications. Perform routine/non-routine data analysis calculations. Document analytical data under cGMP and corporate guidelines. Participate and resolve laboratory investigations of unexpected analytical results. Write/review SOPs, test methods, material specifications, validation protocols and reports. Support cGMP laboratory initiatives following laboratory SOPs. Other duties may be assigned. Qualifications Bachelor's degree in chemistry, biochemistry, or related scientific discipline required. Master's degree preferred. 6 years experience with a Bachelors or 4 years with a Masters Additional Information Interested candidates may contact at Praveen.arora at artechinfo.com or ************
    $71k-104k yearly est. 60d+ ago
  • Junior Systems Engineer

    Technology Service Corp 4.7company rating

    Plymouth, MA job

    We are a moderately-sized and tightly-collaborative team dedicated to producing high-quality products to a mix of defense contractors and commercial customers. We value initiative, adaptability, accountability, communication, teamwork, and are looking for someone who can contribute to the overall success of the organization while managing minor projects of varying scope. Position Overview TSC is seeking a junior Systems Engineer to develop technical solutions for our clients related to RF communication and networking technologies including Mobile Ad hoc Networking (MANET) radios, unmanned aerial products, aviation data link products, SIGINT, and more. This is a great opportunity for a recent graduate or early career professional to gain valuable experience in a collaborative and fast-paced environment. TSC offers a professional working environment, a competitive salary, and an excellent benefits package. Located in Plymouth, MA Key Responsibilities This position requires a flexible individual with electromechanical engineering experience in developing solutions for RF-based networking technologies related to Mobile Ad hoc Networking (MANET) radios, unmanned aerial products, aviation data link products, SIGINT, radio technology, antenna technology and more. This position requires an individual familiar with rapid product development and its inherent challenges to manufacturability. The individual in this position reports to the Lead Systems Engineer with frequent interactions with multidisciplinary engineering teams as well interactions with customers. System Design and Development: Collaborate with cross-functional teams to conceptualize, design, and develop electromechanical systems, products, and components. Conduct feasibility studies, research, and prototyping to validate design concepts. Component Selection and Integration: Specify and select components based on project requirements. Integrate off the shelf components into cohesive systems, ensuring compatibility and functionality. Testing and Validation: Develop and execute test plans and procedures to validate the performance, reliability, and safety of electromechanical systems. Analyze test data and make necessary design modifications to meet specifications. Documentation and Reporting: Create detailed technical documentation, including engineering drawings, schematics, and reports. Maintain accurate records of design changes and project progress. Troubleshooting and Maintenance : Identify and resolve system issues through troubleshooting and diagnostic techniques. Required Qualifications: Bachelor's degree in mechanical, electrical, systems engineering or a relevant technical/engineering discipline. US Citizenship with the ability to obtain and maintain a DoD security clearance. Experience with the following areas is required: Mechanical Design (3D Printing, Sheet Metal, GD&T) Electrical Design (Schematics, Wiring Harnesses, PCB Design) Systems Design (Familiarity with the Systems Engineering Lifecycle) Hand Tools (Screwdrivers, Dremel, Soldering Iron) Preferred Qualifications: Experience working with Mobile Ad hoc Networks (MANETs) Master's degree in systems engineering Experience working in a Research and Development (R&D) environment. Proven experience in developing and improving commercial products. Strong analytical and technical skills. Excellent organizational and communication skills. Demonstrated willingness to learn new concepts and technologies. This contractor and subcontractor shall abide by the requirements of 41 CFR 60-1.4(a), 60-300.5(a) and 60-741.5(a). These regulations prohibit discrimination against qualified individuals based on their status as protected veterans or individuals with disabilities, and prohibit discrimination against all individuals based on their race, color, religion, sex, sexual orientation, gender identity, national origin, or for inquiring about, discussing, or disclosing information about compensation. Moreover, these regulations require that covered prime contractors and subcontractors take affirmative action to employ and advance in employment individuals without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or veteran status. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.
    $63k-84k yearly est. Auto-Apply 57d ago
  • Validation Specialist- III

    Artech Information System 4.8company rating

    Boston, MA job

    Artech is the 10th Largest IT Staffing Company in the US, according to Staffing Industry Analysts' 2012 annual report. Artech provides technical expertise to fill gaps in clients' immediate skill-sets availability, deliver emerging technology skill-sets, refresh existing skill base, allow for flexibility in project planning and execution phases, and provide budgeting/financial flexibility by offering contingent labor as a variable cost. Job Description • QC Instrumentation Services is responsible for the management and implementation of the Laboratory Equipment Qualification system. • It's goal to efficiently specify/source laboratory equipment and execute qualifications in a timely manner to enable QC Microbiology and QC Chemistry departments to execute their functions using equipment which meets their needs and intended use. • This position is responsible for qualifying analytical and microbiological testing instrumentation for the company. • These are some of the responsibilities: • Coordinate activities relating to the qualification, calibration and maintenance of laboratory equipment and related systems. • Coordinate the purchase, commissioning and introduction to service of new equipment. • Establish and maintain Equipment History Files (EHF) for QC laboratory equipment. • Be the contact point for instrumentation issues and provide training and troubleshooting support to the laboratory on new or existing instrumentation. • Coordinate all services provided by vendors, ensuring vendors meet all site requirements. Schedule/plan/execute validation activities and preventive maintenance of laboratory equipment. Skills: • Demonstrated scientific technical writing ability. • Knowledge of USP 1058 and GAMP methodology. • Knowledge of 21CFR Parts 11, 210, 211, 600 and 610. • Experience with Empower and LIMS systems. • Previous hands on experience performing laboratory equipment qualification. • Proficient in Outlook and Microsoft Word and Excel and lab based data management systems. • Ability to gown and enter laboratory • May require off shift work to support activities • Ability to gown and enter laboratory • May require off shift work to support activities Qualifications Education: Bachelor's Degree in Chemistry, Life Sciences, or Engineering discipline and 5 years of Industry relevant experience Or Master's Degree in Chemistry, Life Sciences, or Engineering discipline and 3 years of Industry relevant experience Minimum of 3 years of experience with analytical testing in a laboratory setting, such as HPLC, GC, Ion Chromatography, TOC, UV-Vis, ELISA. Additional Information For more information, please contact: Sneha Shrivastava Technical Recruiter (Clinical/Scientific) Artech Information Systems LLC 360 Mt. Kemble Avenue, Suite 2000 | Morristown, NJ 07960 Office: ************ | Fax: ************ Connect with us on - LinkedIn | Facebook | Twitter
    $85k-116k yearly est. 2d ago
  • Research Associate I (4569058)

    Artech Information System 4.8company rating

    Framingham, MA job

    Artech is the 10th Largest IT Staffing Company in the US, according to Staffing Industry Analysts' 2012 annual report. Artech provides technical expertise to fill gaps in clients' immediate skill-sets availability, deliver emerging technology skill-sets, refresh existing skill base, allow for flexibility in project planning and execution phases, and provide budgeting/financial flexibility by offering contingent labor as a variable cost. Job Description • Responsible for the execution and analysis of experiments and analytical procedures. • Displays an investigative or technological orientation in designing, executing and interpreting experiments and analytical procedures. • Investigates basic technical problems and performs routine scientific procedures and experiments under general supervision. • Plans and prioritizes concurrent experimental procedures. • Integrates, complies, and tabulates data and assists supervisor in the analysis and interpretation of the results. • May provide oral presentations on results to other department members. • Works under active supervision. • Follows established procedures. • Work is reviewed for soundness of technical judgment and overall adequacy and accuracy. • Contributes to the completion of milestones associated with specific projects. • Failure to achieve results or erroneous execution may cause delays in program schedules, and may result in the allocation of additional resources. • Frequent internal company contacts. Infrequent inter- departmental and outside constituent contacts on routine matters. Experience: • 0 to 3 years. Skills: • We seek a motivated, full-time employee to work on a collaborative team creating recombinant cell lines for the production of therapeutic proteins, in support of preclinical and clinical development programs The main responsibilities in this position will be expression vector construction, cell line generation, and cell culture analysis of selected cell lines. • Additional responsibilities will include managing work assignments and data analysis. • Attention to detail and good communication are required. • Experience in molecular cloning, cell line development, and/or flow cytometry. Qualifications • The candidate should have a B.S. degree in Biology, Bioengineering, or related field and a minimum of 1 year of molecular biology and/or mammalian cell culture laboratory experience. • Candidate must have excellent organizational skills and be able to work as part of a team. Additional Information For more information, Please contact Akriti Gupta ************** Morristown, NJ 07960
    $65k-95k yearly est. 2d ago
  • DESKTOP SUPPORT

    Artech Information System 4.8company rating

    Quincy, MA job

    Artech is the 10th Largest IT Staffing Company in the US, according to Staffing Industry Analysts' 2012 annual report. Artech provides technical expertise to fill gaps in clients' immediate skill-sets availability, deliver emerging technology skill-sets, refresh existing skill base, allow for flexibility in project planning and execution phases, and provide budgeting/financial flexibility by offering contingent labor as a variable cost. Job Description Job Title: Desktop Support Representative Onsite Support Location: North Quincy,MA Duration: 1+ years SKILLS OVERVIEW: • Deskside Support Tech. Must be experienced in DESKSIDE support • Win7/Win XP OS support. Troubleshooting • Office 2003/2007/2010 support • Candidates should be able to diagnose and remedy complex Microsoft OS problem tickets, configure and install common applications and install/remove desktop PCs and monitors. • Remote take-over skills a plus. Must have good verbal and written skills, as well as ability to interact positively with clients. • Outlook PST files. • Break/Fix troubleshooting experience in larger corporate environments Additional Information For more information, Please contact Shubham ************
    $51k-69k yearly est. 2d ago
  • QC Chemist

    Artech Information System 4.8company rating

    Framingham, MA job

    Artech is the 10th Largest IT Staffing Company in the US, according to Staffing Industry Analysts' 2012 annual report. Artech provides technical expertise to fill gaps in clients' immediate skill-sets availability, deliver emerging technology skill-sets, refresh existing skill base, allow for flexibility in project planning and execution phases, and provide budgeting/financial flexibility by offering contingent labor as a variable cost. Job Description JobDescription: Skills: Must be detail-orientedand able to work with a high volume of documents in a fast-paced environment.Be highly organized and process-oriented. PreferredQualifications: Additional Information Best Regards, Sneha Shrivastava ***********
    $63k-83k yearly est. 2d ago
  • Regulatory Affairs Specialist

    Artech Information System 4.8company rating

    Cambridge, MA job

    Artech is the 10th Largest IT Staffing Company in the US, according to Staffing Industry Analysts' 2012 annual report. Artech provides technical expertise to fill gaps in clients' immediate skill-sets availability, deliver emerging technology skill-sets, refresh existing skill base, allow for flexibility in project planning and execution phases, and provide budgeting/financial flexibility by offering contingent labor as a variable cost. Job Description • The Regulatory Affairs Operations (RA Ops) submission group is organized to provide submission development support to project teams and the regulatory community. The focus of this position will be to publish, submit and maintain regulatory filings in coordination with Global Regulatory Leads. The role works to tight, business-critical deadlines within a highly regulated environment. • She/he also ensures that compliance standards are met for receipt and delivery of information to and from external consultants and health authorities. • Expert in publishing capabilities of all modules with a competency in the component locations within the eCTD backbone structure. • Support Global Regulatory Leads in the planning, development, and publishing of submissions. • Control submission component receipt and workflow completion to ensure a high quality final submission. Ensure that issues are identified at an early date and actively contribute to issue resolution before filing dates are impacted. • Coordinate publishing tasks associated with assigned submissions, including peer review of submissions generated by other publishers. • Ability to contribute to brainstorming and troubleshooting of technical issues that impact validation requirements for submission dispatch. • Dispatch submissions through the FDA Gateway • Ensure adherence to internal and external standards including Standard Operating Procedures, Guidance Documents, and Policies throughout the lifecycle of the application. • Archive submissions both electronic and paper. Skills: • Proficient in use of MS Office, Adobe Professional, Adobe Add-ins, Publishing Software (sCubed and/or eCTD Manager), Validation Tools and Document Management Systems. • Demonstrate ability to function autonomously in a matrix environment. • Knowledgeable in appropriate ICH and FDA regulations pertaining to regulatory and technical requirements for electronic submissions. • Must be detail oriented and articulate with strong analytical, decision-making, and interpersonal • Demonstrate regulatory knowledge and awareness, technical competence, sound judgment, and a professional demeanor. • Demonstrate flexibility in dealing with change and diversity. • Ability to multi-task in a fast paced environment. • All candidates should have an understanding of the concepts around regulatory affairs and significant knowledge of submissions processes. • Proficient in formatting Word documents prior to publishing and electronic navigation for Adobe documents. Education: At least a bachelor s degree, or equivalent, in regulatory affairs, the sciences, or related areas of study, and relevant experience. Four years submission publishing experience. Additional Information Best Regards, Anuj Mehta ************
    $63k-89k yearly est. 60d+ ago
  • Documentation Specialist-I

    Artech Information System 4.8company rating

    Boston, MA job

    Artech is the 10th Largest IT Staffing Company in the US, according to Staffing Industry Analysts' 2012 annual report. Artech provides technical expertise to fill gaps in clients' immediate skill-sets availability, deliver emerging technology skill-sets, refresh existing skill base, allow for flexibility in project planning and execution phases, and provide budgeting/financial flexibility by offering contingent labor as a variable cost. Job Description Tracking and reviewing change control documentation. Assist with the editing of quality documents (SOP's, guidelines, validation master plans, etc.) to ensure compliance with regulatory requirements. Must be able to work quickly with a high degree of accuracy. Must possess sound interpersonal and information gathering skills, being able to relate well to others at all levels throughout the organization and have the ability to work in a team environment, effectively interacting with others. Experience: 1 to 3 years Required Skills: Strong organizational skills Attention to detail Ability to work cross-functionally Ability to organize work to meet deadlines Qualifications Education: High School Diploma and 1-3 years administrative/professional experience Experience with Microsoft Office products Additional Information For more information, Please contact Sneha Shrivastava ************
    $44k-74k yearly est. 60d+ ago
  • Validation Engineer III

    Artech Information System 4.8company rating

    Framingham, MA job

    Artech is the 10th Largest IT Staffing Company in the US, according to Staffing Industry Analysts' 2012 annual report. Artech provides technical expertise to fill gaps in clients' immediate skill-sets availability, deliver emerging technology skill-sets, refresh existing skill base, allow for flexibility in project planning and execution phases, and provide budgeting/financial flexibility by offering contingent labor as a variable cost. Job Description This position is responsible for documenting Laboratory Equipment Qualification / Validation studies, specifically pertaining to Quality Control. Prepare drafts of the protocol and technical report documentation for review with subject matter experts, project staff and/or customers. Edit, standardize, or revise material prepared by other writers or subject matter experts. Create and revise protocols and technical reports for Laboratory Equipment Qualification (IQ, OQ, and PQ) with input from subject matter experts and according to company policies. Assist multiple teams of technical experts in the technical writing of Laboratory Equipment Qualification Prepare binders containing all relevant documentation. Organize documentation and cross-reference documents as necessary. Route final documents for the appropriate approvals. Revisions of Laboratory Equipment Qualification documentation must be done utilizing defined content and formatting requirements. Ensure cGXP compliance in all documentation. Investigate and document non-conformances in a timely manner. Able train on and follow company SOP documentation standards, templates and practices. Work in compliance with cGMPs. Additional Responsibilities Incorporate new material or information while understanding its implications. Work independently under minimal supervision and direction. Work effectively across organizational and functional boundaries Skills:. Excellent writing and editing skills and must write in a concise and easy-to-read manner Proficient with MS Office Applications Experience with HPLC, Dionex, GC, LCMS, UVVis Spectroscopy and empower software Familiarity with 21CFR part 11 validation automation systems is required. Qualifications Bachelor's degree with 6-9 years in biopharmaceuticals or Life Sciences OR Master s degree with 4-7 years in biopharmaceuticals or Life Sciences 2 years experience working in cGMP environment Additional Information Regards, Akriti Gupta Associate Recruiter Artech Information Systems LLC 360 Mt. Kemble Avenue, Suite 2000 | Morristown, NJ 07960 Office: ************ | Fax: ************ Connect with us on - LinkedIn | Facebook | Twitter
    $84k-113k yearly est. 60d+ ago
  • Research Assistant-II

    Artech Information System 4.8company rating

    Framingham, MA job

    Artech is the 10th Largest IT Staffing Company in the US, according to Staffing Industry Analysts' 2012 annual report. Artech provides technical expertise to fill gaps in clients' immediate skill-sets availability, deliver emerging technology skill-sets, refresh existing skill base, allow for flexibility in project planning and execution phases, and provide budgeting/financial flexibility by offering contingent labor as a variable cost. Job Description • Following successful training, the candidate will be expected to work from home with the requirement to come into the Woodcliff Lake office on Wednesdays each week • Data entry into the Product Safety database for Adverse Events reported in association with Client s Marketed and investigational products. • The activities include, but are not limited to, data entry, coding into standard dictionaries and writing of narratives based on information provided both on standard forms and from medical records and other documents. • The individual will be responsible for verifying the accuracy and completeness of information for each adverse event report for which he/she is responsible in conjunction with the source documents and ensuring that the activities are performed in a manner consistent with Client s SOPs. • Following successful training, the candidate will be expected to work from home with the requirement to come into the Woodcliff Lake office on Wednesdays each week Qualifications • Health Care Professional (with or without previous drug safety experience) or non- health Care Professional with previous drug safety experience desired Medical terminology understanding required, with proficiency with MedDRA or doing into other standard medical coding dictionary preferred 2-3 year s minimum experience in medical coding/terminology/data entry within a pharmaceutical organization. • Computer proficiency required, including data entry into standardized electronic databases STRONG WRITTEN AND VERBAL COMMUNICATIONS ARE ESSENTIAL Experience with data entry into drug safety databases such as ARISg/ARGUS, preferred. • Strong attention to detail and accuracy Strong proofreading, editing and reviewing skills are essential Must be able to work independently, and possess problem solving skills, but also know when to seek assistance from manager. • At Client there are two groups in this department. The one group takes the reports and enters the data into the system. They consider that more of a coordinator position only. This role is more involved because it requires analysis of the narrative on the reports Additional Information Sneha Shrivastava Technical Recruiter (Clinical/Scientific) Artech Information Systems LLC 360 Mt. Kemble Avenue, Suite 2000 | Morristown, NJ 07960 Office: ************ | Fax: ************ Connect with us on - LinkedIn | Facebook | Twitter
    $49k-68k yearly est. 60d+ ago
  • Documentation Specialist III : 4529147

    Artech Information System 4.8company rating

    Framingham, MA job

    At the dawn of the new millennium, a unique information technology company was born: HCL Technologies. As narrated in the video below, HCL Technologies has demonstrated remarkable growth through the recent economic downturn, emerging as one of only eight 21st century listed technology companies in the world to cross $1bn in Net Profit, $6bn in Revenue and $15bn in Market Capitalization. Job Description The Quality Control Chemistry Laboratory is seeking a candidate to fill a QC Documentation Specialist III position. The individual will be responsible to review assay data for completeness in accordance with SOP s, GDP, and regulatory standards. Must possess sound interpersonal and information gathering skills, and candidate is able to relate well with coworkers and at all levels throughout the organization. Candidate is able to work in a team environment where collaboration and interaction is critical to work successfully. Responsible for archiving and retrieval of QC documents, maintain systems for document storage and retrieval, and help train employees on efficient system usage. The QC documentation Specialist may interpret and trend complex data. Position is Monday to Friday Skills: Must be detail-oriented and able to work with a high volume of documents in a fast-paced environment. Be highly organized and process-oriented. They must have excellent oral and written communications skills to interact with all levels of the Quality organization. They must have excellent listening skills, and be able to handle multiple requests while detailing document activity Experience with HPLC (reversed phase and gradient) chromatography and Empower software or equivalent. Experience with QA/QC data review in a regulated industry. Knowledge of FDA regulations, GDP, and cGMP. Preferred Qualifications: Knowledge of SDS-Page, UV-Vis spectrometry (Spectramax plate analysis), and Ion Exchange chromatography (Dionex) is a plus. Experience working in a QC Laboratory environment complete testing and or QC or QA data review role is an advantage. Qualifications Degree in the Life sciences discipline, Bachelor degree and 5+ years of experience, or a master degree and 3+ years of experience Additional Information For more information, please contact Akriti Gupta ************** Morristown, NJ 07960
    $44k-75k yearly est. 60d+ ago
  • QC Chemist

    Artech Information System 4.8company rating

    Framingham, MA job

    Artech is the 10th Largest IT Staffing Company in the US, according to Staffing Industry Analysts' 2012 annual report. Artech provides technical expertise to fill gaps in clients' immediate skill-sets availability, deliver emerging technology skill-sets, refresh existing skill base, allow for flexibility in project planning and execution phases, and provide budgeting/financial flexibility by offering contingent labor as a variable cost. Job Description JobDescription: Skills: Must be detail-orientedand able to work with a high volume of documents in a fast-paced environment.Be highly organized and process-oriented. PreferredQualifications: Additional Information Best Regards, Sneha Shrivastava***********
    $63k-83k yearly est. 60d+ ago

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