Senior QA Specialist - CMC & CDMO Oversight
Precision BioSciences, Inc
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 compliance with regulatory standards. The ideal candidate will have a Bachelor’s degree in a relevant life sciences field, 5+ years of experience in a GMP environment, and strong attention to detail. The position offers minimal travel and a collaborative work environment. #J-18808-Ljbffr Precision BioSciences, Inc
- 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
- 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...SeniorWork at office
- Beam Therapeutics is looking for a Sr. Specialist I in NC Product Quality Assurance to oversee laboratory and manufacturing operations... ...pharmaceutical or biotech industry. Responsibilities include Quality oversight of manufacturing, batch record reviews, and support during...SeniorFlexible hours
$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- ...a shift differential.Job SummaryThe QA Manufacturing Specialist is responsible for ensuring raw materials... ...provide a broad range of quality oversight for activities that support bulk drug... ...Biopharmaceuticals or equivalent is required.MQA Senior Specialist: BS/BA degree in...SeniorWork at officeImmediate startShift workNight shift
- ...consulting firm located in North Carolina is looking for an experienced Quality Assurance professional. The role involves providing QA support to manufacturing processes, reviewing, and approving critical documentation. Candidates should have a Bachelor's degree and over...Senior
- Oxford Biomedica in Durham, North Carolina is seeking a Quality Assurance Senior Specialist to oversee operations in an FDA-approved clinical cGMP manufacturing facility. This role is critical in ensuring compliance and advancing our mission of delivering life-changing...Senior
- OXB is seeking a Senior Specialist in Quality Assurance based in Durham, NC. In this role, you will be responsible for overseeing the compliance within an FDA-approved facility and ensuring quality in all operations. Ideal candidates will bring at least 7 years of experience...Senior
- ...global life sciences provider is seeking a Senior Specialist in Quality Assurance at their... ...location. This role provides crucial on-site QA support to laboratory teams, ensuring compliance... ...lab support, documentation review, and compliance oversight. #J-18808-Ljbffr SolviasSenior
- Senior QA Specialist Deviations and CAPAs page is loaded## Senior QA Specialist Deviations and CAPAslocations: USA - NC - Durham - Hamlin Rdtime type: Full timeposted on: Posted Yesterdayjob requisition id: R00008365Job Summary:Responsible for review and approval of Deviations...SeniorImmediate start
- 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
- ...operations. This position involves collaborating with various departments to resolve compliance issues and providing mentorship to junior QA staff. The ideal candidate will possess a scientific degree and substantial experience in a QA cGMP regulated environment,...Senior
- 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
$113k - $156k
...Biopharmaceutical GMP data. This includes the review and approval of in-process, release, and stability test data. The Principal QA Specialist provides QA oversight of analytical and microbial laboratory activities, including but not limited to method qualification, method...$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- ...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...SeniorFull time
- ...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
- ...committed to doing what’s right in every situation. Make clear commitments and follow through.The Senior Specialist, Quality Assurance provides Quality Assurance (QA) oversight of AskBio’s Vendor Qualification Program for GCLP, GLP, GCP (and GMP vendors, as needed). This...SeniorWork at officeLocal area
- ...Requests (CR's), Deviations & other documentation (in conjunction with LoB) & QA presence & process confirmation on shop floor. Handle release of raw materials & provides quality oversight, review & approval of validation activities associated with minor changes to existing...Local areaShift workNight shift
- ...guided and united by our Group Purpose of “giving our world more smiles.” Visit: Job Description Major Accountabilities Provides QA oversight and support for project deliverables in accordance with the governing processes and procedures for the QC laboratory program...
- Fujifilm Corporation is seeking a Quality Assurance Specialist in Durham, North Carolina. This role involves oversight of QA for project deliverables, ensuring compliance with QC laboratory processes, and fostering collaboration across teams. The ideal candidate holds...
- ...join us. We’re currently recruiting for a Senior QA Specialist, Compliance and Supplier Quality to... ...will be responsible for providing quality oversight of suppliers and vendors supporting the... ...and innovation‑led viral vector CDMO with a mission to enable its clients to...SeniorRemote work
- KBI Biopharma is looking for a QA Manufacturing Specialist responsible for ensuring product quality and compliance with regulations and internal procedures. This position provides oversight for bulk drug substance manufacturing activities and requires experience in a GMP...Night shift
- ...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...SeniorContract work
- 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...SeniorFull timeAfternoon shift
- ...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
- ...Quality Assurance Specialist Location: Onsite at Research Triangle Park, NC Duration: 6 Months Hours: Monday to Friday (30... ...About the role This position is responsible for providing QA oversight and auditing of activities related to clinical and preclinical...Monday to FridayFlexible hours
- ...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...SeniorWorldwide
- ALOIS Solutions is seeking a Quality Assurance Specialist based in Durham, NC. The role involves managing the Quality Management System (QMS), ensuring compliance with GMP regulations, and providing support for QMS-related requests. The ideal candidate will have a Bachelor...
- ...Requests (CRs), 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...Local areaShift workAfternoon shift
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