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
$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- KBI Biopharma in Durham, NC, is seeking a highly skilled analytical professional to join the... ...and qualification activities, and review data with strong documentation practices. The... ...presentation skills, with familiarity in cGMP and regulatory expectations. #J-18808-Ljbffr...DataSenior
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Senior Director, Global Account Management - Emerging BiopharmaJoin... ...partnerships across IQVIA’s Emerging Biopharma portfolio globally. In this... ...closely with IQVIA delivery, data, technology, and commercial... ...pipeline development, opportunity reviews, late-stage funnel activity,...DataSeniorFull timePart timeImmediate startRemote workWorldwide$75.4k - $188.6k
...from Audits; and from Quality Issues, Inspections or during similar QA activities as assigned.Evaluate policies and procedures for... ...Investigator site audits.Experience in the conduct of clinical study report/data management/biostatistics clinical trial audits is preferred....DataSeniorFull timePart timeImmediate startWorldwide$30 - $40 per hour
...site’s documentation and record-keeping systems in accordance with cGMP and regulatory requirements . This role ensures controlled... ...electronic and physical). Support document retrieval and record review during internal and external audits/inspections. Facilitate periodic...Contract workTemporary workWork experience placementWork at officeLocal areaMonday to Friday- ...Document Control & Records Management in Durham, NC to support the site's documentation and record-keeping systems in compliance with cGMP and regulatory requirements. The role ensures controlled documents, SOPs, batch records, and quality forms are created, maintained,...
$118k - $162.8k
...responsible for the validation review and approval of... ...deviations.Provide support for data integrity global... ...- BS/MS and 15+ years/ Senior - BS/MS and 8+ years) experience in a cGMP environment in a computer... ...recognition programs.KBI Biopharma, Inc. is an EEO/AA employer...DataSeniorContract workImmediate start$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- ...accurately to enable implementation. • Work with quality engineering to review, map, and organize Customer Specific Requirements (CSRs) into... ...Compilation by collecting, analyzing, and collating quality data packages (including FMEAs, Control Plans, MSA, and capability...DataWork at officeFlexible hours
- ...this position.The RoleAre you ready to help build a trusted vendor data ecosystem? As a Sr. Vendor Data Quality Analyst at Fidelity... ...findings clearly, concisely, and in an actionable manner, including senior collaborators and cross-functional partners.Outstanding...DataSeniorFull time
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- KBI Biopharma is seeking a Senior Software Engineer to advance data-centric platforms supporting drug development. You will build and scale cloud-based, open and proprietary tools for data exchange, analysis and visualization, collaborating with scientists and engineers...DataSenior
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...across the business? If so, this Senior R&D Procurement Manager role... ...value to GSKLead strategic review with in-depth category knowledgeDetails... ...sourcing events and data-driven negotiations to deliver... ...disease together.GSK is a global biopharma company with a purpose to unite...DataSeniorFull timeContract workLocal area$109.9k - $175.84k
...is what we do every day at Abt. Advancing data-driven innovations is no small task, but... ...your chance.The Opportunity As one of the Senior Toxicologists, you will provide... ...of systematic evidence maps, literature reviews, evidence syntheses, and health hazard assessments...DataSeniorContract workWorldwideFlexible hours$109.9k - $190k
...is what we do every day at Abt. Advancing data-driven innovations is no small task, but... ...your chance.The Opportunity As one of the Senior Epidemiologists, you will provide... ...systematic evidence mapping, literature reviews, evidence synthesis, and health hazard assessments...DataSeniorContract workWorldwideFlexible hours- ...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
- ...Inc. - - Responsibilities: Create production batches and print labels in GLIMS; Print, review, and ensure accuracy of paper batch records for GMP compliance; Enter production data into GLIMS promptly to support batch release; Coordinate daily sampling schedules and escalate...Data
- ...Townsend are seeking an experienced Senior Cost Manager to act as the key... ...healthcare, academic, and biopharma construction projects.Prepare... ...manufacturing environments.Review and collaborate with design teams... ...logs, and benchmarking data for future analysis.Participate...DataSeniorContract workFor contractorsFor subcontractorFlexible hours
$30 - $33 per hour
...print labels in GLIMS to support daily manufacturing operations. Print and review paper batch records to ensure accuracy, completeness, and GMP compliance. Enter GMP production data into GLIMS accurately and in a timely manner to support batch release...DataHourly payContract workTemporary workLocal area- ...Assists Project Team in requests for project information, active and historical.Ensures standardized functional systems (labeling, PFI, data entry, email notifications, customer responses, detailed filing) are used by records technicians and are effectively used.Follow the...DataWorldwideLong distance
- ...Senior Test Lead Cisco is looking for an experienced CPS / PCRF / DRA Mobility 4G Customer Experience Engineer with approximately 1... ...functions to ensure service continuity across geographically dispersed data centers. Linux Administration / Troubleshooting. Good knowledge...DataSenior
- Fidelity is seeking a Principal Business Analyst to organize and streamline data for business decisions using Excel and Power BI. The role involves UI page design, metadata-driven UI, and enterprise-wide initiatives for UI/UX development and platform support. You will...DataSeniorContract work
- ...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
- ...'t build them. About the Position As a Senior Scientist in Formulation Sciences, you will... ...internal or external laboratories, and review data generated by third-party vendors Develop... ...processes into pilot plant, CDMO, and cGMP manufacturing environments Evaluate container...DataSeniorFull timeWorldwide
- MedPharm Ltd in Durham, NC, is seeking a Sr. Director, Technical Operations to lead all cGMP manufacturing activities, ensuring safe, compliant, and cost-effective operations that meet client delivery timelines and quality requirements. This role requires 8+ years in pharma...Senior
$33.68 per hour
...release. Key Responsibilities Create production batches and print labels in GLIMS. Print, review, and ensure accuracy of paper batch records for GMP compliance. Enter production data into GLIMS promptly to support batch release. Collect, aliquot, and deliver samples to...DataContract workTemporary workWork at officeLocal area
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