Senior QA Reviewer, CGMP Biopharma Data
KBI BioPharma
KBI Biopharma, Inc. in Durham, North Carolina is looking for a qualified individual to oversee the compliance review of biopharmaceutical development GMP data. This role involves reviewing and approving release, in-process, and stability test data, as well as method qualifications, validations, and laboratory investigations. The ideal candidate has a BS with 11+ years or MS with 8+ years in a regulated environment, along with substantial experience in QA data review, knowledge of USP, EU, and JP cGMP guidelines, and excellent analytical skills. #J-18808-Ljbffr KBI BioPharma
- KBI Biopharma in Durham, NC is seeking a senior QA reviewer to ensure CGMP compliance for biopharmaceutical development data, including release, in-process, and stability tests. You will evaluate method qualifications/validations, investigations, and deviations with a...DataSenior
- KBI Biopharma in Durham, NC is seeking a Principal QA Specialist responsible for compliance review of Biopharmaceutical GMP data. This role includes reviewing test data, supporting client audits,... ...environment. Strong understanding of FDA and cGMP regulations is required. #J-18808-...DataSenior
- ...US footprint and seeks a Quality Assurance Senior Specialist to lead cGMP-compliant operations in a clinical... ...disposition, and regulatory readiness across QA functions. The ideal candidate brings 7+ years in pharma/biopharma with at least 3 years in QA, strong cGMP knowledge...Senior
- ...schedule Job Summary The QA Manufacturing Specialist, Senior is responsible for... ...for on the floor review of executed records... ...supporting all aspects of cGMP operations. Client... ...forms, in-process data, and logbooks.... ...is preferred. KBI Biopharma, Inc. is an EEO/AA employer...DataSeniorWork at officeImmediate startDay shift
- KBI Biopharma, Inc. in Durham, North Carolina is seeking a Senior Research Associate to join their highly technical analytical team. This role involves performing testing on drug substance/product and conducting data analysis using various bio-analytical techniques such...DataSenior
$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... ...’s with 6+ years in a QA or cGMP environment. Salary ranges from $...Data$63k - $86.9k
...Monday through Friday: The Senior QC Analyst (2nd Shift)... ...and collation of data to draw conclusions. Enter... ...Manufacturing Practices (cGMP). Ensures Trainer... .... Participates in data review activities. Duties may... ...Opportunity Employer KBI Biopharma, Inc. is an EEO/AA employer...DataSeniorFull timeMonday to FridayAfternoon shift- 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
$113k - $156k
## KBI: US - Principal QA SpecialistApplylocations: USA... ...responsible for the compliance review of Biopharmaceutical GMP data. This includes the review... ...procedures, cGLP, and cGMP requirements.* Responsible... ...: $113,000-$156,000***KBI Biopharma, Inc. is an EEO/AA employer...DataImmediate start$80k - $115k
...highly motivated and energetic Senior Analyst to join the QC... ...enable start-up and scale-up of cGMP manufacturing operations across... ...multiple programs. Author and review validation protocols, reports,... ...systems (e.g., LIMS, LES) and assay data sheets, ensuring adherence to...DataSeniorFull time$130k - $160k
...and refine key quality metrics, ensuring data-driven decision-making to enhance product... ...performing quality assurance and quality control (QA/QC) team, fostering a culture of... ...including hourly production employees through senior management. Must possess excellent written...DataSeniorHourly payWork experience placementFlexible hours- ...develop ground-mount solar layouts using AutoCAD Civil 3D. You will also administer CAD standards, QA/QC, and AutoCAD Vault for the engineering group, while supporting data management and mentorship of junior designers. The role requires collaboration with Civil and...DataSenior
- KBI Biopharma in Durham, NC, is seeking a Senior QC Analyst (2nd Shift) to execute analytical test methods for in-process... ...You will perform assays and ensure data quality with minimal supervision in... ...and CAPAs, and maintaining cGMP compliance. #J-18808-Ljbffr KBI BiopharmaDataAfternoon shift
- .... This group works closely across business, product, technology, QA, and operations to ensure system reliability, process accuracy, and... ...business requirements to system functionality, workflows, data flows, and policy admin processes. Partner with developers, QA...DataSeniorFull time3 days per week
- ...About this job: Join KBI Biopharma's Corporate Accounting team as a Senior Accountant and play a pivotal role in driving... ...in a dynamic, mission-driven, and data-driven environment. You will lead... ...delivers robust process development and cGMP manufacturing services across its...DataSeniorContract workImmediate start
$75.4k - $188.6k
...and formulation of corrective action plans Review, approve investigations, Root Cause... ...Quality Issues, Inspections or during similar QA activities as assigned. Evaluate policies... ...Experience in the conduct of clinical study report/data management/biostatistics clinical trial...DataSeniorFull timePart time- ...biopharmaceutical company in North Carolina is seeking a Senior Research Associate to join their... ...will conduct bio-analytical testing and data analysis with various techniques such as... ...advancement and requires adherence to safety protocols. #J-18808-Ljbffr KBI Biopharma Inc.DataSenior
- KBI Biopharma, Inc. is seeking a Senior Accountant to join its Corporate Accounting team in Durham, North Carolina. This role involves driving financial analysis and compliance while working closely with cross-functional teams to support critical business decisions. The...DataSenior
$120k - $150k
...domain expertise, structured enterprise data, and mission-critical workflows that competitors... ...meet you. About the Role: As a Senior QA Automation Engineer / SDET at ENFOS,... ...Clean architecture, automated testing, code reviews, and maintainable software are...DataSenior- KBI Biopharma Inc. seeks a Senior Accountant in Durham, NC to drive financial excellence in a global contract development and manufacturing organization. The role involves leading data-driven analysis, technical accounting, and compliance while collaborating with cross...DataSeniorContract work
- ...responsibilities Create, modify, and execute test cases and test data. Execute exploratory testing to maximize early defect detection... ...and user stories to define test scope and objectives. Develop, review, and maintain comprehensive test plans. Verify accuracy and completeness...DataSeniorLocal areaFlexible hoursNight shift
- ...batches such as DOM/SLED Review, QN and CR review,... ...Experience And Skills: cGMP experience with sterile,... ...document control, master data management, laboratory,... ...Operations, Quality Assurance (QA), Quality Auditing,... ...Requisition ID: R351115 Seniority level Mid-Senior level Employment...DataSeniorFull timeFor contractorsWork at officeLocal areaRemote workRelocationVisa sponsorshipFlexible hoursShift work3 days per week
- ...experimental protocols and performing elementary data analysis in the analytical laboratories.... ...tasks as assigned. Minimum Requirements Senior Research Associate: B.A. or B.S. degree... ..., and factor analysis. EEO Statement KBI Biopharma, Inc. is an EEO/AA employer and actively...DataSenior
- ...Durham, NC, is looking for a Quality Control Analyst specializing in microbiology. This role involves performing cGMP microbiological tests, reviewing data for compliance, and authoring operational procedures. Candidates should possess a BS in Microbiology and at least...Data
- ...Job Summary The Microbiology Senior Associate will be part of the Microbiology Department... ...perform detailed observations and intermediate data analysis. Strong documentation and... ...equipment and testing instruments. Benefits KBI Biopharma offers a challenging, rewarding and fast‑...DataSeniorFull timeContract work
- ...in joining our team? Job Summary The Senior Manager, Quality Operations is... ...site Quality team who performs quality review and approval of documents, data, protocols, qualifications, change controls... ...completion and compliance with cGMP and all other relevant company training...DataSeniorMonday to FridayDay shift
$65.25k - $169.4k
...operations, ensuring compliance with cGMP and regulatory requirements for... ...not limited to batch record review, disposition, deviation... ...protocols and reports, stability data, and analytical methods. Collaborate... ...improvement. Provide expert QA guidance and support during new...DataFull timeH1bVisa sponsorshipWork visaFlexible hours- Aerogen Pharma in Morrisville, NC is seeking a Senior Director of Quality Assurance to lead QA strategy and a small internal team. You will ensure... ...disposition. The role demands 10+ years in biopharma QA with strong cGMP knowledge and direct health authority inspection...Senior
- ...responsible for the compliance review of Biopharmaceutical Development GMP data. This includes the review... ...8+ years experience in a CGMP regulated environment... .... Experience in QA review of analytical data... ...telephone. EEO Statement KBI Biopharma, Inc. is an EEO/AA employer...Data
- ...Our client is seeking a Senior Mechanical Engineer to lead design... ...environmental control needs, including cGMP-regulated facilities and ISO-... ...junior staff, lead technical reviews of critical deliverables, and... ..., battery, aerospace, or data centers (strongly preferred)....DataSeniorFor contractorsRemote workRelocation
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