Sign up to access all features of our service.
  • Job search
  • Favorites
  • Create a CV
    New
  • Salaries
  • Subscriptions

Senior QA Specialist - CMC & CDMO Oversight

NCBiotech

NCBiotech is seeking a Quality Specialist III in Durham, NC, responsible for ensuring quality assurance support for Chemistry, Manufacturing, and Controls (CMC) operations. Key responsibilities include batch release review, deviation assessments, and collaborating with QA leadership. The ideal candidate will have a Bachelor's degree in a relevant field and over 5 years of relevant GMP experience, ensuring compliance with regulatory standards. #J-18808-Ljbffr NCBiotech

Vacancy posted 20 hours ago
Similar jobs that could be interesting for youBased on the Senior QA Specialist - CMC & CDMO Oversight in Durham, NC vacancy
  • Precision BioSciences, Inc in Durham, NC is seeking a Quality Specialist III to provide dedicated quality assurance support for Chemistry, Manufacturing, and Controls operations. This role includes reviewing batch releases, performing deviation assessments, and ensuring... 
    Senior

    Precision BioSciences, Inc

    Durham, NC
    5 days ago
  • KBI Biopharma in Durham, NC is seeking a Principal QA Specialist responsible for compliance review of Biopharmaceutical GMP data. This role...  ...test data, supporting client audits, and providing QA oversight of laboratory activities. The ideal candidate will possess a... 
    Senior

    KBI Biopharma

    Durham, NC
    1 day ago
  • Precision BioSciences, Inc. is seeking a Quality Specialist III responsible for providing quality assurance support for Chemistry, Manufacturing, and Controls (CMC) operations. Key duties include batch release review, deviation assessments, and supporting regulatory compliance... 
    Senior
    Work at office

    Precision BioSciences Inc

    Durham, NC
    4 days ago
  • $113k - $156k

    KBI Biopharma Inc. in Durham, NC is seeking a Principal QA Specialist responsible for compliance review of Biopharmaceutical GMP data. You will provide QA oversight of various laboratory activities and ensure patient safety and regulatory compliance. The ideal candidate... 
    Suggested

    KBI Biopharma Inc.

    Durham, NC
    2 days ago
  • KBI Biopharma in Durham, North Carolina is seeking a qualified candidate for a position responsible for the compliance review of biopharmaceutical development GMP data. This includes overseeing release, in-process, and stability test data, method qualifications, and laboratory...
    Senior

    KBI Biopharma

    Durham, NC
    5 days ago
  • Duke University in Durham, North Carolina, is seeking a qualified candidate for a research oversight position. Responsibilities include training study team members, ensuring compliance with clinical research protocols, and developing necessary documentation. The ideal candidate... 
    Senior

    Duke University

    Durham, NC
    1 day ago
  •  ...timely, compliant study execution. The ideal candidate has eight+ years in clinical research with hands-on study management, TMF oversight, and strong regulatory knowledge. Kubernetes, CTMS and data systems experience valued. #J-18808-Ljbffr Creative Solutions Services... 
    Senior
    Contract work

    Creative Solutions Services, LLC

    Durham, NC
    4 days ago
  •  ...Solutions Services, LLC in Durham, NC is seeking a Clinical Research Associate III to oversee Phase 1 oncology trials and sponsor oversight, including site monitoring, risk identification, and CRO/vendor collaboration. The role requires strong clinical judgment, familiarity... 
    Senior

    Creative Solutions Services, LLC

    Durham, NC
    20 hours ago
  •  ...clinical judgment while building relationships with sites and teams. This role includes on-site and remote monitoring, collaborative oversight of study processes, and the opportunity to travel to investigative sites as required. A minimum of 5 years of experience in... 
    Senior
    Remote work

    Belcan Corporation

    Durham, NC
    2 days ago
  • $113k - $156k

     ...approval of in-process, release, and stability test data. Provides QA oversight of analytical and microbial laboratory activities including...  ...investigations and laboratory deviations. The Principal QA Specialist provides exemplary service to both internal and external... 
    Immediate start

    KBI Biopharma

    Durham, NC
    1 day ago
  • A leading biotechnology company in North Carolina is looking for a Sr QA Specialist to enhance their Quality Management System. The ideal candidate will ensure compliance with regulations, support audits, and engage in continuous process improvement. Candidates should hold... 
    Senior
    Full time

    BioSpace

    Morrisville, NC
    1 day ago
  • Senior Specialist, Quality Assurance The Senior Specialist, Quality Assurance provides Quality Assurance (QA) oversight of AskBio’s Vendor Qualification Program for GCLP, GLP, GCP and GMP vendors. The role performs vendor assessments and audits, ensures compliance with... 
    Senior
    Local area

    AskBio Inc.

    Durham, NC
    4 days ago
  •  ...mentorship to project teams or functions to ensure overall compliance with AstraZeneca and Regulatory requirements are met. Provide QA input into internal manufacturing activities for Drug Substance and Drug Product, including issuance of batch documentation and labels... 
    Senior

    AstraZeneca

    Durham, NC
    3 days ago
  • Responsibilities Review GMP documentation (logbooks, pest control, waterlogs, calibration/maintenance, temperature monitoring, batch records, protocols) for accuracy, completeness, and UT compliance related to combination products. Perform quality assurance activities, ...
    Senior

    Scorpion Therapeutics

    Chapel Hill, NC
    4 days ago
  •  ...QA Compliance Specialist Responsible for review and approval of Deviations and CAPAs in support of GMP manufacturing operations. Support timely review of events for classification, initiation in EtQ and closure. Support external client review and resolution of comments... 
    Senior

    KBI Biopharma

    Durham, NC
    3 days ago
  • Summary The Quality Specialist III is responsible for providing dedicated...  ..., Manufacturing, and Controls (CMC) operations at Precision BioSciences...  ..., deviation assessment, and CDMO oversight. The Quality Specialist III will work closely with QA leadership, operating with... 
    Contract work
    Work at office
    Local area

    Precision BioSciences, Inc.

    Durham, NC
    5 days ago
  •  ...a Quality Control Program to meet contract performance objectives. The role involves overseeing quality reviews, coordinating with senior leadership, and ensuring compliance with regulations. A minimum of 10 years in quality control and 5 years in project management is... 
    Senior
    Contract work

    NVE

    Durham, NC
    4 days ago
  • Alcami Corporation in Morrisville is seeking a Senior Quality Assurance Specialist. This role is responsible for ensuring quality and compliance with regulatory requirements and will include activities such as performing internal audits, maintaining quality databases, and... 
    Senior
    Full time
    Afternoon shift

    Alcami Corporation

    Morrisville, NC
    5 days ago
  •  ...requirements, and cGMP. The role serves as Quality-to-Quality client liaison and sometimes SME for the Quality team, reporting cross-QA metrics and status for KBI and clients. The role is client‑facing and responsible for supporting processes required for product release... 
    Flexible hours

    KBI Biopharma, Inc.

    Durham, NC
    3 days ago
  •  ...Quality Assurance Specialist This position is responsible for providing QA oversight and auditing activities related to clinical and preclinical studies. Examples of activities within the scope of oversight and auditing include but are not limited to: preclinical animal... 
    Flexible hours

    LanceSoft

    Durham, NC
    3 days ago
  •  ...Senior Project Manager Onsite | Durham, NC | Full-Time Position Summary – The Senior...  ...programs across MedPharm’s end-to-end CDMO services. This client-facing position ensures...  ...Project Manager provides strategic oversight, independently manages complex projects and... 
    Senior
    Full time

    MedPharm

    Durham, NC
    3 days ago
  •  ...About the job Senior/Director - Regulatory Affairs Director / Senior Director, Regulatory Affairs About...  ...biologics manufacturing, including past responsibility for and oversight of submissions containing CMC documentation. Background in drug development for... 
    Senior
    Worldwide

    Implaion Recruiting

    Durham, NC
    2 days ago
  • Alcami Corporation in Morrisville, NC is seeking a Senior Quality Assurance Specialist accountable for ensuring quality and compliance in a fast-paced environment. This role includes reviewing documents, conducting audits, and maintaining quality databases while mentoring... 
    Senior
    Night shift

    Alcami Corporation

    Morrisville, NC
    3 days ago
  • $55k - $86.9k

    Job Summary The Manufacturing Quality Assurance (MQA) Specialist supports the manufacturing process within a rapidly expanding GMP contract manufacturing organization. The specialist provides real‑time guidance to manufacturing, collaborates with cross‑functional teams... 
    Contract work
    Shift work

    KBI Biopharma, Inc.

    Durham, NC
    2 days ago
  •  ...Requests (CR's), Deviations & other documentation. Perform Self Audits (in conjunction with line of business (LoB)), Quality Assurance (QA) presence & process confirmation on shop floor. Relationships Reports to Manager, Quality Assurance. Essential Functions Ensure site... 
    Local area
    Shift work
    Afternoon shift

    BioSpace

    Durham, NC
    4 days ago
  •  ...years experience or MS with 8+ years experience in a CGMP regulated environment within biopharmaceuticals or equivalent. Experience in QA review of analytical data (release, in‑process, and stability). Experience in reviewing method qualifications/validations and... 

    KBI Biopharma, Inc.

    Durham, NC
    2 days ago
  • $28 - $31 per hour

     ...s note: This is a supportive QA role focused on Review and approval...  ...for contributing to the oversight of key strategic, and...  ...biologic experience preferred. Seniority level Seniority level Associate...  ...about new Quality Assurance Specialist jobs in Durham, NC . REMOTE -... 
    Contract work
    For contractors
    Remote work
    Night shift

    SGS Consulting

    Durham, NC
    3 days ago
  •  ...lead longer, healthier, and happier lives. Job Summary The Senior Quality Assurance (QA) Associate is responsible for ensuring GMP operations are...  .... This role provides real-time Quality Assurance oversight of GMP operations, with a focus on batch disposition readiness... 
    Shift work
    Rotating shift
    Afternoon shift

    Liquidia Corporation

    Morrisville, NC
    5 days ago
  • $55k - $86.9k

    KBI Biopharma in Durham, NC, is looking for a Manufacturing Quality Assurance Specialist, responsible for supporting the Manufacturing process in a dynamic GMP environment. The role requires real-time guidance to Manufacturing teams, ensuring compliance with standards.... 

    KBI Biopharma

    Durham, NC
    2 days ago
  •  ...Durham, NC to ensure compliance with regulations and approve quality documentation. The ideal candidate will have at least two years of QA experience, preferably in the pharmaceutical industry, and excellent communication skills. This position involves supporting... 

    BioSpace

    Durham, NC
    4 days ago

Do you want to receive more vacancies?

Subscribe and receive similar vacancies to Senior QA Specialist - CMC & CDMO Oversight. Be the first to apply!