QC Analyst II

4 weeks ago


Lexington, Kentucky, United States Genezen Full time
Job Summary

The Quality Control Analyst II will play a crucial role in ensuring the quality and integrity of our products. This position will be responsible for performing routine and non-routine testing, reviewing in-process, DS, and DP release and stability samples, and executing quality systems in accordance with cGMP guidelines.

Key Responsibilities
  • Perform routine and non-routine testing and review of in-process, DS, and DP release and stability samples in accordance with Standard Operating Procedures (SOPs).
  • Execute quality systems, including deviations, corrective and preventive actions (CAPAs), investigations, Out of Specifications (OOS), and change controls.
  • Collaborate with internal and cross-functional teams to support deadlines for release and ensure timely completion of tasks.
  • Participate in equipment validation, method transfer/validation, and special protocol execution.
  • Generate and review protocols and reports as required.
Requirements
  • Bachelor's degree in Chemistry, Biochemistry, or a related science.
  • Minimum 0-5+ years of laboratory experience in QC testing, preferably in a cGMP environment.
  • High proficiency in q-PCR and HPLC methods and analysis.
  • Strong understanding of regulations and ability to apply to any situation, identifying deficiencies with some guidance.
  • Excellent communication and organizational skills, with the ability to work well with others and independently.
Benefits
  • Paid vacation days, amount based on tenure.
  • Paid sick time.
  • 9 observed holidays + 1 floating holiday + 1 volunteer day.
  • 401(k) plan with company match up to 6% of salary, vested immediately.
  • Share Appreciation Rights.
  • Choice of several healthcare plans.
  • FSA and HSA programs.
  • Dental & vision care.
  • Employer-paid basic term life/personal accident insurance.
  • Voluntary disability, universal life/personal accident insurance.
  • Accidental Death & Dismemberment (AD&D) Insurance.
About Genezen

Genezen is a leading provider of gene therapy solutions, committed to delivering timely treatments to patients. We operate with urgency and a commitment to scientific excellence, staying current with industry developments and making data-driven decisions. Our team is dedicated to overcoming challenges, learning from failures, and persistently striving for success.



  • Lexington, Kentucky, United States Genezen Full time

    Job SummaryThe Quality Control Analyst I/II will be responsible for executing routine and non-routine QC testing according to Standard Operating Procedures (SOPs) at Genezen's state-of-the-art facility in Lexington, MA.Key ResponsibilitiesPerform analytical testing, bioassay testing, and Quality Systems in accordance with cGMP guidelines.Execute in-process...


  • Lexington, Kentucky, United States Randstad Full time

    Job Summary:As a leading staffing and recruitment agency, we are committed to finding the perfect role for you in the life sciences arena. Our partner is a biopharmaceutical powerhouse that is changing the world, with a strong focus on Research & Development in Oncology, Neuroscience, Rare Diseases, and Gastroenterology. This role requires employees to be...


  • Lexington, Kentucky, United States LanceSoft Full time

    Job Summary: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 successful candidate will manage their work with limited oversight, handling multiple projects and deliverables, and splitting billing time between...

  • QC Analyst II

    4 weeks ago


    Lexington, Kentucky, United States Genezen Full time

    Job SummaryThe QC Analyst II will be responsible for performing routine and non-routine quality control testing according to Standard Operating Procedures (SOPs). This position is based at Genezen's state-of-the-art facility in Lexington, MA.This role supports the evening and occasional weekend operations within the Quality Control group via execution of...

  • QC Specialist

    4 weeks ago


    Lexington, Kentucky, United States Synectics Inc Full time

    Job SummaryWe are seeking a highly skilled QC Specialist to join our team at Synectics Inc. The successful candidate will be responsible for ensuring the quality and integrity of our products.Key ResponsibilitiesExecute daily lab operations and testing to support manufacturing operations, validation, and development studies.Develop and implement testing...

  • QC Analyst I

    4 weeks ago


    Lexington, Kentucky, United States Genezen Full time

    Job SummaryThe Quality Control Analyst I will be responsible for performing routine and non-routine testing according to Standard Operating Procedures (SOPs) at Genezen's state-of-the-art facility in Lexington, MA. This role supports the operations within the Quality Control group via execution of analytical testing and Quality Systems.Key...

  • QC Manager

    3 weeks ago


    Lexington, Kentucky, United States Genezen Full time

    Job SummaryThe Quality Control (QC) Bioassay and Virology Manager is responsible for overseeing the day-to-day operations of the QC Bioassay and Virology Testing group within the QC Operations department in support of our clinical and commercial AAV-based products.This includes cGMP in-process, lot release, stability, and raw material testing, as well as...


  • Lexington, Kentucky, United States Genezen Full time

    Job OverviewGenezen is seeking a highly skilled QC Scientist Analytical Method Validation to join our Quality Control Technical Services (QCTS) department. This key role will work collaboratively with the analytical development team, quality control, and quality assurance to transfer and validate next-generation analytical procedures for the testing of viral...

  • Technical Specialist

    4 weeks ago


    Lexington, Kentucky, United States NV5 Full time

    Job Overview:The Technical Specialist works to support the Lidar or Ortho Team on various tasking. This individual provides oversight to technicians and other analysts in support of the team leadership. The Technical Specialist has knowledge of all aspects of the Lidar/Ortho workflow and performs rigorous QA/QC and assists in training of analysts and...

  • Geologist II

    4 weeks ago


    Lexington, Kentucky, United States InsideHigherEd Full time

    Job Title: Geologist IIWe are seeking a highly skilled Geologist II to join our team as a Watershed Modeler-GIS Geospatial Analyst. The successful candidate will be responsible for developing hydrogeologic mapping criteria, compiling new digital geospatial data sets for karst hydrogeology, and applying or modifying watershed modeling techniques to identify...


  • Lexington, Kentucky, United States LanceSoft Full time

    Job SummaryThis role is 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 testing samples from drug substance and drug product manufacturing, stability and various protocol studies using approved test methods or test methods...


  • Lexington, Kentucky, United States Apolis Full time

    Job Title: QC IT Application AnalystJob Summary:Apolis is seeking a highly skilled QC IT Application Analyst to join our team. The successful candidate will collaborate with the business and IT teams to provide project support for MA Biologics Operations Site Functions - Quality, Validation and Product Development.Key Responsibilities: Collaborate with the...

  • Technical Specialist

    3 weeks ago


    Lexington, Kentucky, United States NV5 Full time

    Job Summary:The Technical Specialist will support the Lidar or Ortho Team on various tasking, providing oversight to technicians and analysts in support of the team leadership. This individual will work individually and as part of a team to support Lidar data production, producing finalized data deliverables based on client requests.Key Responsibilities:...

  • Technical Consultant

    4 weeks ago


    Lexington, Kentucky, United States Mindlance Full time

    Job Summary: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 ideal candidate will have experience with software application implementations in GxP environments and a strong understanding of Lean operational...


  • Lexington, Kentucky, United States Rapid Micro Biosystems Full time

    About the RoleRapid Micro Biosystems is seeking a skilled Software Test Automation Engineer II to join our team. As a key member of our software development team, you will be responsible for developing and extending automated testing systems to ensure the quality and reliability of our software.You will work closely with our development team to design,...

  • Technical Specialist

    3 weeks ago


    Lexington, Kentucky, United States NV5 Full time

    Job Summary:The Technical Specialist will work to support the Lidar or Ortho Team on various tasking, providing oversight to technicians and other analysts in support of the team leadership. This individual will work individually and as part of a team to support Lidar data production, producing finalized data deliverables based on client requests.Key...

  • Technical Consultant

    4 weeks ago


    Lexington, Kentucky, United States Apolis Full time

    Job Summary: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. This role requires a strong understanding of software application implementations in GxP environments and experience with project upgrades from Win 7 to Win...

  • Laboratory Director

    4 weeks ago


    Lexington, Kentucky, United States Ladgov Corporation Full time

    Job Title: Laboratory DirectorAt Ladgov Corporation, we are seeking a highly skilled and experienced Laboratory Director to lead our laboratory team. The successful candidate will be responsible for ensuring the laboratory provides accurate and reliable medical data, while maintaining a safe and compliant environment.Key Responsibilities:Provide educational...


  • Lexington, Massachusetts, United States Genezen Full time

    The field of gene therapy is rapidly evolving, and Genezen is committed to meeting the exacting needs of our clients.We provide process development, produce GMP viral vectors, and offer cell transduction for gene and cell therapy clinical trials.The QC Analyst I/II will be responsible for routine and non-routine QC testing according to Standard Operating...

  • QC Analyst I/II

    4 weeks ago


    Lexington, Massachusetts, United States Genezen Full time

    Job SummaryThe Quality Control Analyst I/II will be responsible for performing routine and non-routine quality control testing in accordance with Standard Operating Procedures (SOPs). This role supports the evening and occasional weekend operations within the Quality Control group via execution of analytical testing, bioassay testing, and quality systems....


  • Lexington, United States SPECTRAFORCE Full time

    Title: QC IT Application AnalystDuration: 12 Month with potential to extendLocation: Lexington, MAOnsite Expectations:For onboarding and training for the first few weeks should plan to be onsite 4-5 days a week. After onboarding and starting 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...


  • Lexington, United States Sunrise Systems, Inc. Full time

    Job Title: QC IT Application Analyst Job ID: 24-04464 Location: Lexington, MA Duration: 12 Month on W2 contract with potential to extend Onsite Expectations: For onboarding and training for the first few weeks should plan to be onsite 4-5 days a week. After onboarding and starting working on projects, it is a minimum 3 days a week onsite, there will be times...


  • 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: ...


  • Lexington, United States Sunrise Systems, Inc. Full time

    Job Title: QC IT Application Analyst Job ID: 24-04464 Location: Lexington, MA Duration: 12 Month on W2 contract with potential to extend   Onsite Expectations:   For onboarding and training for the first few weeks should plan to be onsite 4-5 days a week. After onboarding and starting working on projects, it is a minimum 3 days a week onsite,...


  • Lexington, United States USDM Life Sciences Full time

    Job Title: QC IT Application Analyst Job Function: Quality Consultant Location: Lexington, MA - Hybrid 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...


  • Lexington, United States USDM Life Sciences Full time

    Job Title: QC IT Application Analyst Job Function: Quality Consultant Location: Lexington, MA - Hybrid 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...

  • QC Analyst II

    3 weeks ago


    Lexington, Massachusetts, United States Genezen Full time

    Job SummaryThe Quality Control Specialist II will be responsible for performing routine and non-routine quality control testing according to established Standard Operating Procedures (SOPs). This position is based at Genezen's state-of-the-art facility in Lexington, MA, and supports the evening and occasional weekend operations within the Quality Control...


  • Lexington, United States USDM Life Sciences Full time

    Job Title: QC IT Application Analyst Job Function: Quality Consultant Location: Lexington, MA - Hybrid About USDM USDM Life Sciences is a premier consulting company with 20+ years of experience assisting heavily regulated biotech, medical device,...


  • Lexington, Massachusetts, United States Genezen Full time

    Job SummaryThe QC Scientist Analytical Method Validation is a key role within our Quality Control Technical Services (QCTS) department at Genezen. This position will work collaboratively with the analytical development team, quality control, and quality assurance to transfer and validate next-generation analytical procedures for the testing of viral vectors,...

  • Help Desk Analyst II

    2 weeks ago


    Lexington, United States Robert Half Full time

    Job DescriptionJob DescriptionWe are providing a long-term contract employment opportunity for a Help Desk Analyst II in Westford, Massachusetts. The successful candidate will be instrumental in offering technical support and maintaining accurate inventory records of IT assets. This role is at the forefront of interacting directly with clients, ensuring a...


  • lexington, United States SPECTRAFORCE Full time

    Description:Position Title: QC Analyst – BiochemistryDuration: 06 months (potential extension)Location: Lexington, MA, 02142Job Summary/Operations Involvement: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...


  • lexington, United States SPECTRAFORCE Full time

    Description:Position Title: QC Analyst – BiochemistryDuration: 06 months (potential extension)Location: Lexington, MA, 02142Job Summary/Operations Involvement: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...


  • Lexington, United States SPECTRAFORCE Full time

    Description:Position Title: QC Analyst – BiochemistryDuration: 06 months (potential extension)Location: Lexington, MA, 02142Job Summary/Operations Involvement: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...

  • QC Manager/Sr. Manager

    24 hours ago


    Lexington, United States Genezen Full time

    The field of gene therapy is growing rapidly and Genezen is here to meet the exacting needs of our clients. We provide process development, produce GMP viral vectors, and provide cell transduction for gene and cell therapy clinical trials and are proud to be a part of the process that leads to new cures. WORKING AT GENEZEN Many people have worked in...


  • Lexington, United States Apolis Full time

    POSITION TITLE: QC IT Application AnalystDURATION: 12 Month contract with potential to extendLOCATION: Lexington, MA, USA 02421 (Hybrid role)Pay Rate Range - $70.00-90.00/hour on W2.Onsite Expectations:For onboarding and training for the first few weeks should plan to be onsite 4-5 days a week. After onboarding and starting working on projects, it is a...


  • lexington, United States TalentCraft Full time

    Job Title: Quality Control Bioassay and Virology Operations LeadPosition Summary:This role is responsible for the daily management and operations of the QC Bioassay and Virology Testing team within the QC Operations department, supporting clinical and commercial AAV-based products. Key responsibilities include overseeing cGMP processes such as in-process,...


  • Lexington, United States TalentCraft Full time

    Job Title: Quality Control Bioassay and Virology Operations LeadPosition Summary:This role is responsible for the daily management and operations of the QC Bioassay and Virology Testing team within the QC Operations department, supporting clinical and commercial AAV-based products. Key responsibilities include overseeing cGMP processes such as in-process,...


  • lexington, United States TalentCraft Full time

    Job Title: Quality Control Bioassay and Virology Operations LeadPosition Summary:This role is responsible for the daily management and operations of the QC Bioassay and Virology Testing team within the QC Operations department, supporting clinical and commercial AAV-based products. Key responsibilities include overseeing cGMP processes such as in-process,...