Scientist - QC Data Review

1 month ago


Boston, Massachusetts, United States Thermo Fisher Scientific Full time

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Adherence to all Good Manufacturing Practices (GMP) Safety Standards

Job Description

At Thermo Fisher Scientific, you'll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on – now and in the future.

Thermo Fisher's clinical research business is a leading global contract research organization and world leader in serving science. We are passionate, deliberate, and driven by our mission – to enable our customers to make the world healthier, safer, and cleaner.

Within our Analytical Services team, we have a functional service provider solution, which is a unique partnership that allows our customers to leverage the experience of our staff, while allowing you, the employee, to gain direct experience working onsite at a pharmaceutical/ biopharmaceutical company, all while maintaining full-time benefits.

Key responsibilities:
  • Quality Control (QC) Associate to support Contract Drug Manufacturing Organization and Contract Labs for the applicable programs. This position will work closely with QC, Quality, and other departments to manage data and documents. This position will support QC activities, data review, document management, and maintain content aligns with source documentation.
  • Supports QC point of contact for CDMO and CTL associated with QC test results
  • Participates in cross functional workstreams in analytical data review
  • Updates scheduling/planning/TAT of test results from CTL and CDMO
  • Maintains spreadsheets via data entry and verification of data review
  • Collaborates with internal stakeholders to retrieve information
  • Instill and adhere to GLP and GCP regulations, relevant SOPs, protocols, policies
  • Identify risks and gaps with documentation
  • Create and format datasets, memos, and reports as needed
Education and Experience:
  • Bachelor's degree in lab sciences such as Chemistry, Biochemistry, Material Science, Immunology, Biology, Molecular Biology or similar
  • Scientist: Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2+ years')
  • OR Masters degree

In some cases, an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.

Knowledge, Skills and Abilities:
  • Experience in the pharmaceutical industry, biotech industry, life sciences industry and understanding of drug development process in cGMP setting.
  • Experience with creating/revising documents in an electronic document management system
  • Complete projects according to outlined scope, budget, and timelines
  • Proficiency in Microsoft Word/Excel and Smartsheet
  • Demonstrate success in a fast-paced, multi-tasking environment
  • Detail-oriented
  • Strong written and verbal communication skills
Working Environment:

Below is listed the working environment/requirements for this role:

Able to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner.

Able to work upright and stationary and/or standing for typical working hours.

Able to lift and move objects up to 25 pounds

Able to work in non-traditional work environments.

Able to use and learn standard office equipment and technology with

proficiency.

May have exposure to potentially hazardous elements, including infectious agents, typically found in healthcare or laboratory environments.

Able to perform successfully under pressure while prioritizing and handling multiple projects or activities.

Benefits

We offer competitive remuneration, annual incentive plan bonus, healthcare, and a range of employee benefits. Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects. We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation


  • data scientist

    3 months ago


    Boston, Massachusetts, United States Tangle Systems LLC Full time

    Tangle System has an immediate requirement for Data Scientist in Boston MAThe AIML (Artificial Intelligence and Machine Learning) team contributes to the vitality and growth of the organization through researching and building complex cutting edge and scalable AI algorithms models platforms and technologies to significantly improve customer experience and...


  • Boston, Massachusetts, United States Liberty Mutual Insurance Full time

    Pay PhilosophyThe typical starting salary range for this role is determined by a number of factors including skills, experience, education, certifications and location. The full salary range for this role reflects the competitive labor market value for all employees in these positions across the national market and provides an opportunity to progress as...

  • Data Scientist

    2 months ago


    Boston, Massachusetts, United States Tempus AI Full time

    Passionate about precision medicine and advancing the healthcare industry?Recent advancements in underlying technology have finally made it possible for AI to impact clinical care in a meaningful way. Tempus' proprietary platform connects an entire ecosystem of real-world evidence to deliver real-time, actionable insights to physicians, providing critical...

  • Data Scientist

    3 weeks ago


    Boston, Massachusetts, United States Cambridge Associates Full time

    CAREERS THAT CHANGE THE WORLDOUR CLIENTSCambridge Associates believes our clients come first.Our clients are the most compelling endowments, foundations, pensions, private clients and institutional investors around the globe. We lock arms with them to meet and exceed their investment objectives, so they can change the world.OUR CULTURECambridge Associates...

  • Data Scientist III

    2 months ago


    Boston, Massachusetts, United States Chewy Full time

    We are hiring amazing humans, and we hope that includes youAre you looking for more than just a job? At Chewy, you'll find yourself on a career path with other amazing humans, like yourself. You'll be part of a culture that values everything that you do, who you are, and the goals you have set for your career. We want to give you the opportunity to grow,...

  • Data Scientist III

    2 weeks ago


    Boston, Massachusetts, United States Chewy Full time

    Are you looking for more than just a job? At Chewy, you'll find yourself on a career path with other amazing humans, like yourself. You'll be part of a culture that values everything that you do, who you are, and the goals you have set for your career. We want to give you the opportunity to grow, earn competitive pay, and be happy while you do it. Sounds...

  • Senior Data Scientist

    1 month ago


    Boston, Massachusetts, United States Chubb Full time

    Job DescriptionSenior Data ScientistThe North America PRS (Personal Risk Services) Data Science team at Chubb is seeking a data scientist with 4+ years of industry experience to join our fast-paced, high-energy team. This team is responsible for building data pipelines and delivering predictive modeling and data science solutions to our business partners...


  • Boston, Massachusetts, United States Caris Life Sciences Full time

    Position SummaryWe are seeking a Principal Scientist to join the Data Science unit at our Cambridge, MA office to develop and leverage innovative computational biology algorithms supporting translational research use of Caris' large-scale multi-omics data.The scientist will work closely with our Data Science, Software Engineering, and Laboratory R&D teams to...


  • Boston, Massachusetts, United States Boston Consulting Group Full time

    Locations: Boston | Chicago | Washington | Pittsburgh | New York | Brooklyn | Manhattan Beach | Dallas | Miami | San Francisco | Seattle | Los AngelesWho We AreBoston Consulting Group partners with leaders in business and society to tackle their most important challenges and capture their greatest opportunities. BCG was the pioneer in business strategy when...


  • Boston, Massachusetts, United States Massachusetts General Hospital Full time

    GENERAL SUMMARY/OVERVIEW STATEMENT: Summarize the nature and level of work performed. The Massachusetts General Hospital (MGH) Corrigan Minehan Heart Center and Cardiovascular Research Center is seeking a highly motivated individual with expertise in Data Science and Machine Learning to work on multiple clinical and translational research projects focused on...


  • Boston, Massachusetts, United States CarGurus Full time

    Who we areAt CarGurus (NASDAQ: CARG), our mission is to give people the power to reach their destination. We started as a small team of developers determined to bring trust and transparency to car shopping. Since then, our history of innovation and go-to-market acceleration has driven industry-leading growth. In fact, we're the largest and fastest-growing...


  • Boston, Massachusetts, United States Elektrofi Full time

    Our breakthrough ultra-high concentration microparticle technology platform resolves the limitations associated with intravenously biologic therapies by enabling convenient at-home subcutaneous self-administration.Elektrofi is looking for a Translational Scientist/ Senior Scientist to support the development of the novel Elektrofi formulation platform.The...


  • Boston, Massachusetts, United States PepGen Full time

    Associate Director, Quality Control Reporting to the Senior Director, Analytical Development & Quality Control (QC), the Associate Director of Quality Control will be acting as QC lead, responsible for leading and managing the QC activities of PepGen's pipeline. In addition, this position will be required to actively support the preparation of regulatory...

  • Data Scientist

    3 days ago


    Boston, Massachusetts, United States Beth Israel Deaconess Medical Center Full time

    Job SummaryThe Data Scientist will be an MEng, PhD, or someone with similar educational or work experience who has both conceptual/theoretical and practical/hands-on expertise in data science, artificial intelligence, machine learning (including deep learning), and related areas and is highly motivated to contribute to scientific and engineering advances in...


  • Boston, Massachusetts, United States Workhuman Full time

    Job Description:The OpportunityThe IQ team at Workhuman is seeking a Senior People Data Scientist to help drive innovation (new methods, new applications, new tools) across our people analytics and data science engagements with external clients and internal cross-functional teams.If you have a passion for combining consulting skills with analytical know-how,...


  • Boston, Massachusetts, United States CDM Smith Full time

    37716BR Requisition ID: 37716BR Business Unit: TSU Job Description: With high-level goals provided, prepares environmental studies (eg, NEPA documents, field reports, feasibility studies, etc.) of basic to high complexity for transportation, facility and transit projects. Collaborates with scientists, engineers, and construction staff to implement the...

  • Associate Scientist

    1 month ago


    Boston, Massachusetts, United States Thermo Fisher Scientific Full time

    Work ScheduleStandard (Mon-Fri)Environmental ConditionsAdherence to all Good Manufacturing Practices (GMP) Safety StandardsJob DescriptionAt Thermo Fisher Scientific, you'll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner...

  • Research Scientist

    2 days ago


    Boston, Massachusetts, United States Massachusetts General Hospital Full time

    Job SummaryThe Massachusetts General Hospital is seeking a highly skilled Research Scientist to join their team and contribute to their mission to improve health outcomes for pregnant and lactating individuals and their children. Working under the guidance of Dr. Camille E. Powe and the Diabetes Research Center Management, the Research Scientist will provide...


  • Boston, Massachusetts, United States Eli Lilly and Company Full time

    At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities...


  • Boston, Massachusetts, United States Manifold Bio Full time

    Manifold Bio is a biotech company pursuing a pipeline of protein therapeutics using novel molecular measurement technologies and library-guided protein engineering.Our drug discovery engine is differentiated by massively parallel screening in vivo from the beginning of our discovery process.We combine this and other high-throughput protein engineering...