3 jobs found in waltham, massachusetts

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    • waltham, massachusetts
    • contract
    • US$27.17 - US$31.97, per hour, $27.17 - 31.97 per hour
    • 9 to 5
    job summary:As the world's largest staffing and recruitment agency in the world, we can commit to find you the perfect role that gives you the opportunity to learn and grow in the life sciences arena. Utilizing a recruiter for your job search gives you access to a large network of top employers as well as detailed information about hundreds of positions. Focusing on immune diseases like HIV that affect a large percentage of the population, the work our longtime partner conducts is imperative to a better, healthier future. To be recognized as a crucial part to furthering this goal, join this growing team now! location: Waltham, Massachusettsjob type: Contractsalary: $27.17 - 31.97 per hourwork hours: 9 to 5education: Bachelors responsibilities:- Support product batch disposition by conducting review of executed batch record; disposition documentation package preparation; review of deviations.- Accurately update/maintain batch trackers; lot genealogies; compliance trackers such as Quality alerts; Quality bulletin; KPIs, etc.- Manage/upload product disposition documentation in the controlled documentation system ensuring proper archival.- Clearly communicate issues as applicable to CMOs and Quality management in a timely basis- Review and approve documentation related to production and / or packaging operations as assigned.- As appropriate attend project meetings qualifications:- Minimum bachelor's degree in science (Biology; Chemistry; Biotechnology; Pharmaceutical Science)- Minimum of 8+ years of experience in pharmaceutical industry with at least 3-5 years in Quality (no rookies)- Experience and working knowledge on Small molecules chemistry, tablets and capsules.- Experience building relationships and working with CMOs- Working knowledge ICH/EMA/FDA regulations- Competency in MS Office, Adobe Acrobat, Veeva, Trackwise- Able to work a flexible work schedule to accommodate program priorities skills: CAPA, GMP (Good Manufacturing Practice)Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.
    job summary:As the world's largest staffing and recruitment agency in the world, we can commit to find you the perfect role that gives you the opportunity to learn and grow in the life sciences arena. Utilizing a recruiter for your job search gives you access to a large network of top employers as well as detailed information about hundreds of positions. Focusing on immune diseases like HIV that affect a large percentage of the population, the work our longtime partner conducts is imperative to a better, healthier future. To be recognized as a crucial part to furthering this goal, join this growing team now! location: Waltham, Massachusettsjob type: Contractsalary: $27.17 - 31.97 per hourwork hours: 9 to 5education: Bachelors responsibilities:- Support product batch disposition by conducting review of executed batch record; disposition documentation package preparation; review of deviations.- Accurately update/maintain batch trackers; lot genealogies; compliance trackers such as Quality alerts; Quality bulletin; KPIs, etc.- Manage/upload product disposition documentation in the controlled documentation system ensuring proper archival.- Clearly communicate issues as applicable to CMOs and Quality management in a timely basis- Review and approve documentation related to production and / or packaging operations as assigned.- As appropriate attend project meetings qualifications:- Minimum bachelor's degree in science (Biology; Chemistry; Biotechnology; Pharmaceutical Science)- Minimum of 8+ years of experience in pharmaceutical industry with at least 3-5 years in Quality (no rookies)- Experience and working knowledge on Small molecules chemistry, tablets and capsules.- Experience building relationships and working with CMOs- Working knowledge ICH/EMA/FDA regulations- Competency in MS Office, Adobe Acrobat, Veeva, Trackwise- Able to work a flexible work schedule to accommodate program priorities skills: CAPA, GMP (Good Manufacturing Practice)Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.
    • waltham, massachusetts
    • contract
    • US$100.00 - US$120.00, per hour, $100 - 120 per hour
    • 9 to 5
    job summary:Will provide operational input and oversight for a large Phase 3 oncology clinical study. This individual will interface directly with internal and external partners to drive data cleaning efforts for IDMC, interim analysis for NDA, and final database lock. location: Waltham, Massachusettsjob type: Contractsalary: $100 - 120 per hourwork hours: 9 to 5education: Bachelors responsibilities:Lead interim analysis process by developing and operationalizing the data cleaning plan in collaboration with internal/external stakeholders, including multiple CROs and vendors, such as biostatistics, data management, PV, clinical operations, clinical development, clinical supply chain, quality, and regulatory affairs including but not limited to data review plan, clinical data listings, EDC reports, IVRS/IRT reports, vendor data, and study drug reconciliationLead study team for all clinical operations deliverables leading to database lock for interim analysis for NDA filing - leading, managing and working with CROs and other vendors on IDMC data cleaning, clinical monitoring activities, database lock activities and study close-out activities Develop plan for resolution of queries and SDV in light of COVID-19 impactIdentify study data issues by reviewing and monitoring of emerging data related to safety, efficacy, and PK/PDDevelop sound solutions to data review/data cleaning issues and collaborates with clinical study team to ensure issue resolutionSupport with monitoring and analysis of emerging data trendsAssist with in-house and site inspection-readiness planningProvide input into clinical timelinesInteract with internal and external stakeholders (VP, Clinical Development, study sites, vendors, committees) in support of clinical study objectives; responds to or triages questions for appropriate escalationsAssist with clinical operations strategy including risk management and contingency planningBuild collaborative relationships with key internal stakeholders to facilitate the planning and execution of clinical trialsEnsure all clinical trials are executed per key metrics (timelines, operational and quality standards [ICH/GCP/SOPs])Maintain procedures to verify the accuracy and timeliness of trial information in all trial databases and tracking systemsPerform other duties as assigned related to clinical study qualifications:12 + years of clinical operations experience in a pharmaceutical, biotech, and/or CRO setting, including management of a CRO; and 9+ years clinical study/program managementBS in the health or life sciences or equivalentOncology experience, especially solid tumor, and familiarity with RECIST, is a MUSTLate-stage clinical study data management and extensive data cleaning experience; prior oversight of close-out of large oncology trial is a MUSTDemonstrated ability to review, clean and interpret data for interim analysis, DSMB, database lock, NDA submissionAnalytical thinker with excellent problem-solving skills and the ability to adapt to changing priorities and deadlinesStrong leadership, interpersonal, organization, documentation, communication skillsProven ability to build strong relationships with CROs/vendorsExcellent computer skills (Microsoft Office Suite, Project, Visio, Electronic Data Capture and Trial Master File Systems)This position is remote skills: Phase iii, Clinical Data Management, GCP (Good Clinical Practice), ICH RegulationsEqual Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.
    job summary:Will provide operational input and oversight for a large Phase 3 oncology clinical study. This individual will interface directly with internal and external partners to drive data cleaning efforts for IDMC, interim analysis for NDA, and final database lock. location: Waltham, Massachusettsjob type: Contractsalary: $100 - 120 per hourwork hours: 9 to 5education: Bachelors responsibilities:Lead interim analysis process by developing and operationalizing the data cleaning plan in collaboration with internal/external stakeholders, including multiple CROs and vendors, such as biostatistics, data management, PV, clinical operations, clinical development, clinical supply chain, quality, and regulatory affairs including but not limited to data review plan, clinical data listings, EDC reports, IVRS/IRT reports, vendor data, and study drug reconciliationLead study team for all clinical operations deliverables leading to database lock for interim analysis for NDA filing - leading, managing and working with CROs and other vendors on IDMC data cleaning, clinical monitoring activities, database lock activities and study close-out activities Develop plan for resolution of queries and SDV in light of COVID-19 impactIdentify study data issues by reviewing and monitoring of emerging data related to safety, efficacy, and PK/PDDevelop sound solutions to data review/data cleaning issues and collaborates with clinical study team to ensure issue resolutionSupport with monitoring and analysis of emerging data trendsAssist with in-house and site inspection-readiness planningProvide input into clinical timelinesInteract with internal and external stakeholders (VP, Clinical Development, study sites, vendors, committees) in support of clinical study objectives; responds to or triages questions for appropriate escalationsAssist with clinical operations strategy including risk management and contingency planningBuild collaborative relationships with key internal stakeholders to facilitate the planning and execution of clinical trialsEnsure all clinical trials are executed per key metrics (timelines, operational and quality standards [ICH/GCP/SOPs])Maintain procedures to verify the accuracy and timeliness of trial information in all trial databases and tracking systemsPerform other duties as assigned related to clinical study qualifications:12 + years of clinical operations experience in a pharmaceutical, biotech, and/or CRO setting, including management of a CRO; and 9+ years clinical study/program managementBS in the health or life sciences or equivalentOncology experience, especially solid tumor, and familiarity with RECIST, is a MUSTLate-stage clinical study data management and extensive data cleaning experience; prior oversight of close-out of large oncology trial is a MUSTDemonstrated ability to review, clean and interpret data for interim analysis, DSMB, database lock, NDA submissionAnalytical thinker with excellent problem-solving skills and the ability to adapt to changing priorities and deadlinesStrong leadership, interpersonal, organization, documentation, communication skillsProven ability to build strong relationships with CROs/vendorsExcellent computer skills (Microsoft Office Suite, Project, Visio, Electronic Data Capture and Trial Master File Systems)This position is remote skills: Phase iii, Clinical Data Management, GCP (Good Clinical Practice), ICH RegulationsEqual Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.
    • waltham, massachusetts
    • contract
    • US$39.38 - US$46.33, per hour, $39.38 - 46.33 per hour
    • 9 to 5
    job summary:As the world's largest staffing and recruitment agency in the world, we can commit to find you the perfect role that gives you the opportunity to learn and grow in the life sciences arena. Utilizing a recruiter for your job search gives you access to a large network of top employers as well as detailed information about hundreds of positions. Located in 100 countries, our longtime partner is known for being the world's largest producer of vaccines and for covering seven major therapeutic areas. To be a part of the science that is changing the world, apply now! location: Waltham, Massachusettsjob type: Contractsalary: $39.38 - 46.33 per hourwork hours: 9 to 5education: Bachelors responsibilities:The SCES Q manager Person in Plant acts as the day-to-day liaison with internal and external customers for quality related activities.- Ensure GMP compliance of products manufactured and/or tested at a contract facility.- Ensure all aspects of product manufacturing and/or testing are reviewed versus establishedquality standards and the applicable marketing authorizations.- Manage Quality Systems, e.g. change control, deviations, complaints, and product investigations.- Modify, review, and ensure contractor quality standards and protocols for processing materials into partially finished or finished product meet the company and GMP requirements.- Contribute to the completion of milestones associated with specific projects.Core Responsibilities- Release product in accordance with approved specifications and procedures.- Monitor contractor compliance via GxP documentation review and on-site visits/audits.- Implement methods and procedures for inspecting, testing, and evaluating the precision andaccuracy of products and production equipment.- Compile data and write summaries for periodic product reviews, investigations, complaints, and deviations.- Distribute applicable contractor documentation for Regulatory, Validation, and Subject Matter Expert review.- Interact with multi-functional internal and external project teams to ensure compliance.- Respond to technical and quality issues and handle schedule and/or process-related conflicts.- Demonstrate understanding of applicable US and global regulations related to manufacture of medicinal products (small molecules and biologics).- Monitor contractor performance to established Key Performance Indicators (KPI) and report adverse trends.Additional Responsibilities- May assist in vendor selection and evaluation.- Provide QA project manager support for change controls and other projects.- Develop and manage Quality Technical Agreements between the company and the contractor- Participate in contractor quality audits and verify any actions taken by the contractor in response to audit observations are completed satisfactorily.- Support program for maintaining performance metrics. qualifications:Bachelor's degree and 10+ years of experience working in a cGxP or other regulated environment, with 3+ years of experience in a Quality role. skills: Project Management, Quality control, Quality Assurance, GMP (Good Manufacturing Practice)Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.
    job summary:As the world's largest staffing and recruitment agency in the world, we can commit to find you the perfect role that gives you the opportunity to learn and grow in the life sciences arena. Utilizing a recruiter for your job search gives you access to a large network of top employers as well as detailed information about hundreds of positions. Located in 100 countries, our longtime partner is known for being the world's largest producer of vaccines and for covering seven major therapeutic areas. To be a part of the science that is changing the world, apply now! location: Waltham, Massachusettsjob type: Contractsalary: $39.38 - 46.33 per hourwork hours: 9 to 5education: Bachelors responsibilities:The SCES Q manager Person in Plant acts as the day-to-day liaison with internal and external customers for quality related activities.- Ensure GMP compliance of products manufactured and/or tested at a contract facility.- Ensure all aspects of product manufacturing and/or testing are reviewed versus establishedquality standards and the applicable marketing authorizations.- Manage Quality Systems, e.g. change control, deviations, complaints, and product investigations.- Modify, review, and ensure contractor quality standards and protocols for processing materials into partially finished or finished product meet the company and GMP requirements.- Contribute to the completion of milestones associated with specific projects.Core Responsibilities- Release product in accordance with approved specifications and procedures.- Monitor contractor compliance via GxP documentation review and on-site visits/audits.- Implement methods and procedures for inspecting, testing, and evaluating the precision andaccuracy of products and production equipment.- Compile data and write summaries for periodic product reviews, investigations, complaints, and deviations.- Distribute applicable contractor documentation for Regulatory, Validation, and Subject Matter Expert review.- Interact with multi-functional internal and external project teams to ensure compliance.- Respond to technical and quality issues and handle schedule and/or process-related conflicts.- Demonstrate understanding of applicable US and global regulations related to manufacture of medicinal products (small molecules and biologics).- Monitor contractor performance to established Key Performance Indicators (KPI) and report adverse trends.Additional Responsibilities- May assist in vendor selection and evaluation.- Provide QA project manager support for change controls and other projects.- Develop and manage Quality Technical Agreements between the company and the contractor- Participate in contractor quality audits and verify any actions taken by the contractor in response to audit observations are completed satisfactorily.- Support program for maintaining performance metrics. qualifications:Bachelor's degree and 10+ years of experience working in a cGxP or other regulated environment, with 3+ years of experience in a Quality role. skills: Project Management, Quality control, Quality Assurance, GMP (Good Manufacturing Practice)Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.

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