Randstad Life Sciences US | QC Analyst II

3 weeks ago

lexington, United States Randstad Life Sciences US Full time

6 Month Contract

Lexington, MA

PR: $40-53/hour


Job Summary

Primary Duties of this position will focus on the daily lab operations and execution of testing to support manufacturing operations /validation/or development studies. Testing may include but not limited to samples from drug substance and drug product manufacturing, stability and various protocol studies using approved test methods or test methods derived from QC technical protocols. May assist in sampling activities. This position is expected to maintain operational and GMP readiness of the QC areas as well as maintain critical reagent inventory such as antibodies and cell banks at business appropriate quantities. In addition, the individual may participate in more complex projects, operational excellence initiatives, and various quality systems with general supervision.


Job Responsibilities

  • Specific Biochemistry Focus Areas:
  • Product Testing: Area focuses on techniques such as SDS-PAGE Silver, QPCR, Potency, Kinetics assay, Enzyme Activity, pH, Osmo, A280 etc., in order to support in-process, release and stability testing.
  • Role supports commercial and clinical testing for defined site-based and external programs, as well as method transfer and validation. Introduction of new equipment and technology to improve sustainability and compliance is expected.
  • Additionally, the role provides support for Quality projects and implementation of operational excellence initiatives.
  • 40-50% Testing execution, participate in training analysts, trouble shooting of methods
  • 20-30%: QC operations support which entails data review, data trending, OE/5S/LEAN initiatives, maintenance of equipment and reagents, lab house keeping, support for other QC groups. Compliance and quality systems (SOP revisions, input to quality systems records)
  • 10-20% Involvement in various departmental and cross-functional teams and initiatives; inspection and regulatory support


Education & Qualifications

  • Typically requires a bachelor’s degree and a minimum of 5+ years of related experience. (science related degree is preferred)
  • Excellent communication, interpersonal and organizational skills.
  • Ability to work well both independently and in a team environment.
  • Ability to prioritize work and multitask.
  • Previous experience in a GMP QC role is preferred
  • Key Skills, Abilities, and Competencies
  • Describe critical skill and abilities needed to successfully perform the job, which should be representative of the knowledge, skills, and abilities required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
  • Complete understanding and application principles, concepts, practices and standards. Full knowledge of industry practices. Position requires critical thinking.
  • Key Skills: MS Office, LIMS, SAP, Trackwise , compliance and strong science understanding
  • Limited to no travel expected. Travel between sites is required.
  • The following physical abilities are required in order to fulfill the job duties:
  • Repetitive bending and reaching to setup and break-down equipment (if required by specific activity)
  • Ability to work around chemicals (if working around the laboratories)
  • Ability to wear personal protective equipment such as gloves, gowning, and respiratory protection in some cases
  • Ability to walk and stand for periods of time
  • Individual may be required to participate in environmental chamber monitoring program which would include the use of an on-call mobile phone as well as on-site support during non-business hours

  • Randstad Life Sciences US | QC Analyst II

    3 weeks ago

    lexington, United States Randstad Life Sciences US Full time

    6 Month ContractLexington, MAPR: $40-53/hourJob SummaryPrimary Duties of this position will focus on the daily lab operations and execution of testing to support manufacturing operations /validation/or development studies. Testing may include but not limited to samples from drug substance and drug product manufacturing, stability and various protocol studies...

  • QC Analyst II

    2 months ago

    Lexington, United States Randstad Life Sciences US Full time

    6 Month ContractLexington, MAPR: $40-52/hourJob SummaryPrimary Duties of this position will focus on the daily lab operations and execution of testing to support manufacturing operations /validation/or development studies. Testing may include but not limited to samples from drug substance and drug product manufacturing, stability and various protocol studies...

  • QC Analyst II

    2 months ago

    Lexington, United States Randstad Life Sciences US Full time

    6 Month ContractLexington, MAPR: $40-52/hourJob SummaryPrimary Duties of this position will focus on the daily lab operations and execution of testing to support manufacturing operations /validation/or development studies. Testing may include but not limited to samples from drug substance and drug product manufacturing, stability and various protocol studies...

  • Quality Assurance Specialist

    3 weeks ago

    Lexington, Kentucky, United States Randstad Life Sciences US Full time

    Job SummaryWe are seeking a highly skilled QC Analyst II to join our team at Randstad Life Sciences US. In this role, you will be responsible for the daily lab operations and execution of testing to support manufacturing operations/validation/or development studies.The primary duties of this position will focus on techniques such as SDS-PAGE Silver, QPCR,...

  • Randstad Life Sciences US | Quality Assurance Validation Consultant | lexington, ky

    2 weeks ago

    lexington, United States Randstad Life Sciences US Full time

    Quality ConsultantHourly Pay: 150 an hourLocation: Lexington, MA (3 days a week onsite)Description: We are seeking a skilled QAV professional with expertise in primarily Method Validation and Analytical Instrument Qualification (AIQ) to support key initiatives within their laboratory operations. Their expertise may not be limited to these areas but may...

  • QC IT Application Analyst

    3 months ago

    Lexington, United States Sunrise Systems Full time

    Job Description: The QC IT Application Analyst collaborates with the business and IT teams to provide project support for MA Biologics Operations Site Functions – Quality, Validation and Product Development. The QC IT Application Analyst manages their work with limited oversight- The scope of work includes, but is not limited to the following: ...

  • QC IT Application Analyst

    3 weeks ago

    Lexington, United States LanceSoft Full time

    Shift: 8AM to 5PM Onsite Expectations: For onboarding and training for the first few weeks should plan to be onsite 4-5 days a week. After onboarding and started working on projects, it is a minimum 3 days a week onsite, there will be times to be on site 4-5 days as needed. Job Description: The QC IT Application Analyst collaborates with the business...

  • GForce Life Sciences | Bioanalytical Data Reviewer | lexington, ky

    4 weeks ago

    lexington, United States GForce Life Sciences Full time

    Operational Data Steward – Lexington, MA Must be able to work on a W2Bioanalytical Data reviewer/ Quality Control - ContractorThis position is responsible for the quality control of all nonGLP data generated in the Nonclinical Pharmacology group.Key Responsibilities:• Work closely with scientists within the ADME group to verify bioanalytical data...

  • QC IT Application Analyst

    3 weeks ago

    Lexington, United States USDM Full time

    About USDM USDM Life Sciences is a premier consulting company with 20+ years of experience assisting heavily regulated biotech, medical device, and pharmaceutical companies with their GxP technologies to accelerate growth. Our deep domain knowledge and technology expertise in life sciences business processes are what sets us apart. From strategy to...

  • QC Analyst

    4 weeks ago

    Lexington, United States Synectics Inc Full time

    Job DescriptionJob DescriptionDescription:Daily lab operations and execution of testing to support manufacturing operations /validation/or development studies.Testing may include but not limited to samples from drug substance and drug product manufacturing, stability and various protocol studies using approved test methods or test methods derived from QC...

  • QC Analyst II – Biochemistry

    2 weeks ago

    Lexington, United States The Fountain Group Full time

    Pay: 48.00-58.00/hr.Length of Assignment: 6 months to start with potential for extension. qPCR experience required.Primary Duties of this position will focus on the daily lab operations and execution of testing to support manufacturing operations /validation/or development studies. Testing may include but not limited to samples from drug substance and drug...

  • Senior Software Engineers

    3 weeks ago

    Lexington, United States Randstad Digital Full time

    Senior Software Engineers for Randstad Digital, LLC. Multiple openings. Headquarters: Woburn, MA. Develop, design, and implement Enterprise and Market Data applications, high-performance and scalable system for real-time trading, Cloud infrastructure, and dashboards. Write queries and scripts, implement concurrent data ingestion pipelines, enable real-time...

  • Senior Software Engineers

    3 weeks ago

    Lexington, United States Randstad Digital Full time

    Senior Software Engineers for Randstad Digital, LLC. Multiple openings. Headquarters: Woburn, MA. Develop, design, and implement Enterprise and Market Data applications, high-performance and scalable system for real-time trading, Cloud infrastructure, and dashboards. Write queries and scripts, implement concurrent data ingestion pipelines, enable real-time...

  • Hadoop Administrators

    3 weeks ago

    Lexington, United States Randstad Digital Full time

    Hadoop Administrators for Randstad Digital, LLC. Multiple openings. Headquarters: Woburn, MA. Engineer, design, develop, administer, and support databases, networks, infrastructure, components and systems. Initiate corrective actions, maintain schedule, and install, configure, upgrade, and test networks, operating systems, and big data deployments. Develop...

  • Senior Software Engineers

    3 weeks ago

    Lexington, United States Randstad Digital Full time

    Senior Software Engineers for Randstad Digital, LLC. Multiple openings. Headquarters: Woburn, MA. Develop, design, and script programs, data migration processes, modeling, data pipeline architecture, solution, platforms, and systems architecture. Integrate data, ingest multirecord files with data formats, track progress, mitigate risks, and review financial...

  • Senior Software Quality Assurance Automation Test Engineers

    3 weeks ago

    Lexington, United States Randstad Digital Full time

    Senior Software Quality Assurance Automation Test Engineers for Randstad Digital, LLC. Multiple openings. Headquarters: Woburn, MA. Develop, design, and execute software testing strategies, automated test scripts, test plans and matrices, and solutions. Collaborate with development, internal teams, product owners, and business users. Troubleshoot, identify...

  • Senior Specialist, Quality Assurance Operations

    2 weeks ago

    Lexington, United States Wave Life Sciences Full time

    Job Description Wave Life Sciences is a biotechnology company focused on unlocking the broad potential of RNA medicines to transform human health. Our RNA medicines platform, PRISM, combines multiple modalities, chemistry innovation and deep insights in human genetics to deliver scientific breakthroughs that treat both rare and prevalent disorders. Our...

  • Senior Specialist, Quality Assurance Operations

    2 weeks ago

    Lexington, United States Wave Life Sciences Full time

    Job Description Wave Life Sciences is a biotechnology company focused on unlocking the broad potential of RNA medicines to transform human health. Our RNA medicines platform, PRISM, combines multiple modalities, chemistry innovation and deep insights in human genetics to deliver scientific breakthroughs that treat both rare and prevalent disorders. Our...

  • Bioanalytical Data Reviewer

    4 weeks ago

    Lexington, United States GForce Life Sciences Full time

    Operational Data Steward – Lexington, MA Must be able to work on a W2Bioanalytical Data reviewer/ Quality Control - ContractorThis position is responsible for the quality control of all nonGLP data generated in the Nonclinical Pharmacology group.Key Responsibilities:• Work closely with scientists within the ADME group to verify bioanalytical data...

  • The Fountain Group | QC Analyst II – Biochemistry | lexington, ky

    2 weeks ago

    lexington, United States The Fountain Group Full time

    Pay: 48.00-58.00/hr.Length of Assignment: 6 months to start with potential for extension. qPCR experience required.Primary Duties of this position will focus on the daily lab operations and execution of testing to support manufacturing operations /validation/or development studies. Testing may include but not limited to samples from drug substance and drug...