Analytical QC Analyst

3 weeks ago


Durham, United States Insight Global Full time

Must Haves:

  • Bachelor's Degree in STEM or related
  • 5+ years of experience in cGMP manufacturing
  • Direct experience and understanding of ELISA, cell-based bioassays, molecular based assays such as PCR and ddPCR, kinetic binding assays, and particle sizing by DLS.
  • Experience with real-time PRC and digital droplet PCR

Pluses:

  • Experience with CE-SDS and AUC
  • Previous experience in analytical technology transfer for biopharmaceuticals

Job Description:

Our client is seeking a Senior QC Analyst to join their expanding team in the RTP area. The Analytical Method Lifecycle Senior Associate will support the overall management and delivery of phase appropriate analytical method verification/qualification/validation and method transfer between clients and Resilience stakeholders. The Method Lifecycle Senior Analyst will ensure that all aspects of method lifecycle are conducted at the site in compliance with cGMP regulations, relevant compendial requirements, company policies, standards and procedures and safety standards. The Analytical Method Lifecycle Senior Analyst will support all site activities to ensure timely and successful execution of method lifecycle activities at the site. Specific activities include authoring/executing/review of study design, protocols and reports associated with analytical method qualification/validation/transfer. 70% of time will be executing studies outline in protocols.

Responsibilities:

  • Support the site’s Analytical Method Lifecycle program encompassing all Quality activities to support method transfers and validation.
  • Interface directly with client stakeholders for quality or compliance issues associated with analytical methods.
  • Contribute to product specification development and ensure alignment with method capabilities.
  • Support QC method/analytical investigations (OOS/OOT) at the site.
  • Review and approve SOPs as required.
  • Performs all other related duties as assigned.


  • Durham, United States Insight Global Full time

    Must Haves:Bachelor's Degree in STEM or related5+ years of experience in cGMP manufacturing Direct experience and understanding of ELISA, cell-based bioassays, molecular based assays such as PCR and ddPCR, kinetic binding assays, and particle sizing by DLS. Experience with real-time PRC and digital droplet PCR Pluses:Experience with CE-SDS and AUC Previous...


  • Durham, United States Insight Global Full time

    Must Haves:Bachelor's Degree in STEM or related5+ years of experience in cGMP manufacturing Direct experience and understanding of ELISA, cell-based bioassays, molecular based assays such as PCR and ddPCR, kinetic binding assays, and particle sizing by DLS. Experience with real-time PRC and digital droplet PCR Pluses:Experience with CE-SDS and AUC Previous...


  • Durham, United States Insight Global Full time

    Must Haves:Bachelor's Degree in STEM or related5+ years of experience in cGMP manufacturing Direct experience and understanding of ELISA, cell-based bioassays, molecular based assays such as PCR and ddPCR, kinetic binding assays, and particle sizing by DLS. Experience with real-time PRC and digital droplet PCR Pluses:Experience with CE-SDS and AUC Previous...

  • QC Analyst 1

    2 weeks ago


    Durham, United States Biofire Diagnostics, LLC Full time

    This position is in a fast-paced, FDA regulated environment in the Medical Devices/ Diagnostics Industry. The QC Microbiology Analyst 1 will be in a key position in the microbiology laboratory performing testing of Growth Performance, Antimicrobial N Microbiology, Biology, Analyst, QC, Microbiology, Data Entry, Manufacturing, Education

  • QC Analyst 1

    1 day ago


    Durham, United States Biofire Diagnostics, LLC Full time

    This position is in a fast-paced, FDA regulated environment in the Medical Devices/ Diagnostics Industry. The QC Microbiology Analyst 1 will be in a key position in the microbiology laboratory performing testing of Growth Performance, Antimicrobial N Microbiology, Biology, Analyst, QC, Microbiology, Data Entry, Manufacturing, Education

  • QC Analyst 1

    3 weeks ago


    Durham, North Carolina, United States bioMerieux SA Career Site - MULTI-LINGUAL Full time

    Description Position Summary:This position is in a fast-paced, FDA regulated environment in the Medical Devices/Diagnostics Industry. The QC Microbiology Analyst 1 will be in a key position in the microbiology laboratory performing testing of Growth Performance, Antimicrobial Neutralization, and Contamination Checks. In this role you will execute routine...


  • Durham, United States Insight Global Full time

    Job Description:Our client is seeking a Senior QC Analyst to join their expanding team in the RTP area. The Analytical Method Lifecycle Senior Associate will support the overall management and delivery of phase appropriate analytical method verification/qualification/validation and method transfer between clients and Resilience stakeholders. The Method...


  • Durham, United States Insight Global Full time

    Job Description:Our client is seeking a Senior QC Analyst to join their expanding team in the RTP area. The Analytical Method Lifecycle Senior Associate will support the overall management and delivery of phase appropriate analytical method verification/qualification/validation and method transfer between clients and Resilience stakeholders. The Method...


  • Durham, United States Insight Global Full time

    Job Description:Our client is seeking a Senior QC Analyst to join their expanding team in the RTP area. The Analytical Method Lifecycle Senior Associate will support the overall management and delivery of phase appropriate analytical method verification/qualification/validation and method transfer between clients and Resilience stakeholders. The Method...

  • QC Analyst 1

    2 weeks ago


    Durham, United States Biofire Diagnostics Full time

    Position Summary: This position is in a fast-paced, FDA regulated environment in the Medical Devices/Diagnostics Industry. The QC Microbiology Analyst 1 will be in a key position in the microbiology laboratory performing testing of Growth Performance, Antimicrobial Neutralization, and Contamination Checks. In this role you will execute routine tests per...

  • QC Analyst 1

    2 weeks ago


    Durham, United States Biomerieux S.A. Full time

    Description Position Summary: This position is in a fast-paced, FDA regulated environment in the Medical Devices/Diagnostics Industry. The QC Microbiology Analyst 1 will be in a key position in the microbiology laboratory performing testing of Growth Performance, Antimicrobial Neutralization, and Contamination Checks. In this role you will execute routine...

  • QC Analyst 1

    2 days ago


    Durham, United States Biomerieux S.A. Full time

    Description Position Summary: This position is in a fast-paced, FDA regulated environment in the Medical Devices/Diagnostics Industry. The QC Microbiology Analyst 1 will be in a key position in the microbiology laboratory performing testing of Growth Performance, Antimicrobial Neutralization, and Contamination Checks. In this role you will execute routine...

  • QC Analyst 1

    2 days ago


    Durham, United States Biofire Diagnostics Full time

    Position Summary: This position is in a fast-paced, FDA regulated environment in the Medical Devices/Diagnostics Industry. The QC Microbiology Analyst 1 will be in a key position in the microbiology laboratory performing testing of Growth Performance, Antimicrobial Neutralization, and Contamination Checks. In this role you will execute routine tests per...


  • Durham, North Carolina, 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...

  • QC Microbiologist

    1 day ago


    Durham, NC, US Piper Companies Full time

    Piper Companies is currently seeking a QC Microbiologist for an opportunity in Durham, North Carolina (NC), to join a multinational pharmaceutical manufacturer bringing forward life-saving medications and vaccines. Responsibilities of the QC MicrobiologistContribute to the development of pharmaceutical drug manufacturing by performing a variety of...


  • Durham, United States Beam Therapeutics Inc. Full time

    Position Overview: We are seeking a motivated Sr. Manager to lead the Potency and Functional assay team driving method transfer, qualification, and validation and routine GMP execution of cell-based potency and functional assays for cell and gene therapy products. The individual will be responsible for managing the internal potency and functional assay group...


  • Durham, United States Beam Therapeutics Inc. Full time

    Position Overview: We are seeking a motivated Sr. Manager to lead the Potency and Functional assay team driving method transfer, qualification, and validation and routine GMP execution of cell-based potency and functional assays for cell and gene therapy products. The individual will be responsible for managing the internal potency and functional assay group...


  • Durham, 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...


  • Durham, 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...


  • Durham, United States Actalent Full time

    Description: The Analytical Method Lifecycle Associate will support the overall management and delivery of phase appropriate analytical method verification/qualification/validation and method transfer between stakeholders of our client and their customers. The Method Lifecycle Analyst will ensure that all aspects of method lifecycle are conducted at the...