CSV Validation Specialist II - 21 CFR & Data Integrity
KBI Biopharma
KBI Biopharma in Durham, North Carolina, is seeking a skilled CSV Specialist to support the validation processes ensuring compliance with industry regulations. The role entails authoring protocols and conducting data analysis while managing documentation archives. The ideal candidate will have 3–5 years of experience in the pharmaceutical or biotechnology sector, with a solid understanding of GAMP and regulatory frameworks. Strong problem-solving and communication skills are essential, as well as proficiency in Microsoft Office and electronic document management systems. #J-18808-Ljbffr KBI Biopharma
- ...the Computer Systems Validation (CSV) Lifecycle for the Validation... ..., test scripts, and data tables to facilitate... ...EU Annex11, and data integrity. The role will also be... ...experience as a CSV Specialist or in a comparable role... ...experience with GAMP and 21 CFR Part11 compliance,...DataWork at office
$65k - $90.82k
...collective expertise Position Summary The CSV/CQV Engineer will support the commissioning, qualification, and validation of process equipment, utilities, facilities,... ...all computerized system validation (CSV) and data integrity (DI) activities, working under the direction...DataTemporary workWork experience placementLocal area$65k - $90.82k
Verista in Durham, North Carolina is seeking a CSV/CQV Engineer to support the commissioning, qualification, and validation of process equipment and utilities. This role requires a Bachelor's degree in engineering and at least 5 years of experience in CSV within pharmaceutical...Data- ...Quality Assurance Specialist II Locations: Research Triangle Park, NC... ...studies, qualification and/or validation of methods, equipment/... ...processes, reports, records, and data for accuracy and compliance with... ..., a solid understanding of 21 CFR Part 11, and laboratory standards...DataFlexible hours
- ...Laboratory Assistant II Duration: 25 Weeks Location: Research Triangle Park, North Carolina- 27709 Pay rate: $24/hr on W2 Job... ...environmental monitoring system when it calls Maintain critical data and metadata within LIMS, including but not limited to Consumables...DataWork experience placementWork at office
- BioAgilytix in Durham, NC seeks a Scientist II to lead the development and validation of Anti-drug Antibody (ADA) and PK... ...will drive assay development, data generation, and client... ...mentoring analysts and ensuring data integrity within milestone-driven timelines....Data
- ...Overview Accentuate Staffing is seeking a Workday HRIS Analyst II to join a growing HR Systems team. This role supports the full... ...deliver effective, scalable Workday solutions Perform regular data integrity audits to ensure accuracy and consistency across HR systems Provide...DataLive in
- ...be responsible for being a MES system specialist for the site. The ideal candidate... ...Configuration Specifications, process and data flow charts, supporting risk... ...associated regulatory requirements including 21 CFR Part 11, Data Integrity, etc. Knowledge of the IT system...Data
- ...Title: Quality Control Associate II Duration: 1 Year+ Primary... ...nitrates. Executing TOC method validations and all associated activities... ...activities in a cGMP manner. Data review/analysis, analytical/... ...Singh Clinical Recruiter Integrated Resources, Inc Tel: (732) 429...Data
$108.5k - $201.5k
...future projects including integration of 3rd party equipment... ...DCS and BMS systems, data concentration, batch reporting... ...meet GMP requirements, CFR’s and internal company... ...of system level validation testing including providing... ...particularly 21 CFR part 11 and GMP systems...DataFor contractorsWork experience placementLocal areaRelocation package- ...which is Duke Health's fully integrated, centralized revenue cycle organization... ...The Medical Records Coder II is a certified Coder.... ...accurate. Abstract and compile data from medical records for appropriate... ...Coding; Certified Coding Specialist (CCS) Hospital Coding; Certified...Data
$135k - $310.5k
...We help companies connect, protect, analyze, and act on their data and applications wherever they live, from edge to cloud, so they... ...of multidimensional designs involving the layout of complex integrated circuits. Analyzes designs to establish operating data, conducts...DataFull timeWork experience placementWork at officeLocal areaImmediate start2 days per week- ...Associate II, Quality Control At Real we're... ...medical companies. As specialists in recognising talent... ...for qualification/validation/certification activities... ...review/corrections for data and documentation. Perform... ...equipment to ensure integrity of all laboratory...DataLocal area
- ...Analysis and collation of data to draw conclusions Trend analysis... ...qualification, and/or method validation testing under protocol... ...years' experience. QC Analyst II requires Bachelor's degree as... ...organization (CDMO) providing fully integrated and accelerated drug development...DataFull timeContract workImmediate start
$30 - $38 per hour
QC Associate II Location: 5000 Davis Drive, Research Triangle Park... ...to testing, method transfer, validation, and laboratory operations... ...investigations, and ensuring the integrity and accuracy of laboratory... ...laboratory systems to ensure data integrity and reliable test results...DataWeekly payContract workMonday to Friday$19.06 - $28.85 per hour
...Hospital, Duke Raleigh Hospital, Duke Health Integrated Practice, Duke Primary Care, Duke Home... .... Work Performed A Research Technician II position is available immediately in the... ...preparing research-related documents, performing data analysis, maintaining standard laboratory...DataWork experience placementImmediate start$19.06 - $28.85 per hour
...Research Technician II Work Arrangement: On-Site Location: Durham, NC, US, 27710... ...Hospital, Duke Raleigh Hospital, Duke Health Integrated Practice, Duke Primary Care, Duke Home... ...biological experiments to generate and analyze data. The person compiles results, draws...DataWork experience placementRemote work- ...preparation analysis and collation of data to draw conclusions. Trend... ...qualification, and/or method validation testing under protocol.... ...years’ experience. QC Analyst II: Bachelor’s degree as described... ...organization (CDMO) providing fully integrated and accelerated drug...DataFull timeContract work
- ...will join us. Overview The Staff Accountant II role is a position that will fill a... ...and financial tasks to ensure the accuracy, integrity, and compliance of financial records and reports... ...and ability to analyze large Excel‑based data sets Working knowledge of Microsoft Office...DataWork at office3 days per week
- ...can advance health together. Duke Health Integrated Practice Duke Health Integrated Practice... ...state of North Carolina. Clinical Nurse II Part Time- Duke Asthma, Allergy and... ...providers. Collect and analyze patient data, make recommendations for nursing care plans...DataPart timeWork at officeRemote workMonday to Friday
- ...collaborative Research Associate II to support AAV delivery... ...high‑quality and reproducible data, and support day‑to‑day laboratory... ...notebook in accordance with data integrity standards Analyze data,... ...employment decisions are based on valid job‑related requirements. If...DataLocal area
- ...subsidiary of Bayer AG, is a fully integrated gene therapy company dedicated... ....The Quality Control Analyst II will be responsible for... ...trending activities for analytical data.Maintains laboratory... ...employment decisions are based on valid job‐related requirements. If you...DataLocal area
$124k - $195.5k
...Engineer to join our Air team - the Digital Twin for Data Center Simulation web application. To learn more,... .... Perform software verification and validation, including functional, regression, and system integration testing. Identify, analyze, and track software defects...Data- ...subsidiary of Bayer AG, is a fully integrated gene therapy company... ...The Analytical Lab Operations Specialist II will be responsible for supporting... ...gaps. Participate in data review processes to ensure accuracy... ...decisions are based on valid job‑related requirements. If...DataLocal area
$80 - $120 per hour
...environment? We’re hiring a DeltaV Specialist with strong knowledge of... ..., SAT, commissioning, and validation Support batch process... ...performance in line with GAMP5 and 21 CFR Part 11 standards Author and... ..., and IT teams to ensure data integrity and compliance What You Bring...DataContract work$1,875 per month
...OSTOMY CERTIFIED CLINICAL SERVICES NURSE II/III Work Arrangement: On-Site Requisition... ...coordinating the care. The WOC CSN is an integral part of multiple teams, as a clinician, educator... ...research Uses quality‑monitoring data to assess the quality and effectiveness of...DataTemporary workRelocationMonday to Friday- ...across a variety of industries providing integrated engineering and consulting services. Our... ...experience includes design for data centers, healthcare, science and technology... .... Perform Commissioning, Qualification, Validation team activities. Control CQV plan by reviewing...DataFull timeWork experience placementLocal area
$98.7k - $183.3k
...changing therapies to reach patients safely and efficiently. As a Validation Engineer III, you will play a critical role in bringing... ...support specialized validation activities Analyze validation data to confirm accuracy, completeness, and regulatory compliance Develop...DataRelocation package- Vulcan-Elements in Durham, North Carolina is seeking an Integrations Engineer to connect operational and business systems. This role focuses on ensuring reliable data movement across the organization and supporting Vulcan's data and AI capabilities. The ideal candidate...Data
$86.71k - $140.13k
...Raleigh Hospital, Duke Health Integrated Practice, Duke Primary Care, Duke... ..., Quality Assurance Associate II, to join our team. In this... ...across manufacturing, engineering, validation, and quality functions. Your... ...monitoring and assist with data analysis, when required. Conduct...DataWork experience placementWork at officeShift work
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