Senior QA Reviewer, CGMP Biopharma Data
KBI Biopharma, Inc.
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, Inc.
- 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,... ...with 8+ years of experience in a CGMP-regulated environment, alongside...DataSenior
$113k - $156k
KBI Biopharma, Inc. in Durham, North Carolina seeks a Principal QA Specialist to oversee compliance review of GMP data. This role includes reviewing in-process, release, and stability test data, providing QA support for laboratory activities, and ensuring regulatory compliance...DataSenior$63k - $86k
...is responsible for performing data review for contract services... ...analytical testing, understanding cGMP standards is recommended. Knowledge... .... Minimum Requirements Senior Research Associate: B.A or B.... ...Salary $63,000‑$86,000 KBI Biopharma, Inc. is an EEO/AA employer and...DataSeniorContract work- 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
$63k - $86k
KBI Biopharma, Inc. is seeking a Senior Research Associate in Durham, North Carolina to join its analytical team. This role entails performing data reviews for contracted client analytical programs. The ideal candidate should have a B.A./B.S. in chemistry or biochemistry...DataSenior- 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
$63k - $86.9k
...Position Summary: The Senior QC Analyst (2nd Shift)... ...and collation of data to draw conclusions... ...Manufacturing Practices (cGMP) Ensures Trainer qualification... ...Participates in data review activities Duties... ...$63,000-$86,900 KBI Biopharma is committed to providing...DataSeniorFull timeImmediate startMonday to FridayAfternoon shift- ...Quality Assurance professional. The role involves providing QA support to manufacturing processes, reviewing, and approving critical documentation. Candidates... ...'s degree and over 8 years of experience in a QA cGMP environment. The company fosters an inclusive work culture...Senior
- KBI Biopharma Inc. is looking for a Sr/Principal Computer Systems Validation Specialist in Durham... ...enterprise software validation in a cGMP environment, providing expert guidance on... ...Candidates need substantial experience in Data Integrity and FDA regulations. The salary...DataSeniorRemote job
- ...sciences company in Morrisville, North Carolina, is looking for a Senior Scientist to support analytical activities for large... ...The role involves ensuring compliance with GMP standards, reviewing laboratory data, and utilizing analytical techniques like UPLC/HPLC. Applicants...DataSenior
$113k - $156k
...responsible for the compliance review of Biopharmaceutical GMP data. This includes the review... ...test data. The Principal QA Specialist provides QA... ...required procedures, cGLP, and cGMP requirements. Review and... ...156,000 EEO Statement KBI Biopharma, Inc. is an EEO/AA...Data- ...Senior Data Developer (Snowflake) Location: Durham, NC or Smithfield, Rhode Island, San Francisco, CA Duration: 12+ months Job Description... ...and associated tools such as SQL, Python, Excel, etc. ~ QA / Testing – must be highly proficient in QA and testing...DataSenior
- ...Job Summary: Perform data review for commercial program documents including Process Performance Verification (PPQ) reports, Continuous... ...regulatory deliverables or client interactions. KBI Biopharma, Inc. is an EEO/AA employer and actively seeks to diversify its...DataImmediate start
$113k - $156k
...responsible for the compliance review of Biopharmaceutical GMP data. This includes the review... ...test data. Provides QA oversight of analytical and... ...required procedures, cGLP, and cGMP requirements. Responsible... ...56,000 EEO Statement KBI Biopharma, Inc. is an EEO/AA...DataImmediate start- ...Senior QA Architect VAST Data is looking for a Senior QA Architect to join our growing team! This is a great opportunity to be part of one of the... ...taking active part in the team tasks Assigns tasks, reviews work and may contribute to employee performance appraisals...DataSenior
- .... This role involves influencing software design, writing automated tests, and collaborating with team members to enhance testing processes. The position offers a flexible working environment with opportunities to grow within the company. #J-18808-Ljbffr NTT DATA, Inc.DataSeniorFlexible hours
- Position Overview Quality Control Senior Analyst, Microbiology We’re currently recruiting... ...testing, environmental monitoring, data review and trending, and implementation of GMP operational... ...therapies. Responsibilities Perform cGMP microbial testing including endotoxin,...DataSenior
- ...Position Overview The Senior QA Technical Specialist acts independently... ...of computerized system and data integrity PQS subsystems.... ...Bioprocess Innovation Center to our cGMP-compliant manufacturing site,... ...Major Accountabilities: Review and approval of validation...DataSenior
- KBI Biopharma Inc. is seeking a Principal Quality Compliance Specialist in Durham, NC. This role involves reviewing and approving deviations and CAPAs to ensure GMP compliance, mentoring... ...minimum of 14 years' experience in a QA cGMP regulated environment, with a comprehensive...Senior
- ...leadership to junior team or project members, with strict adherence to QA/QC. Developed critical thinking and problem-solving skills... ...apply technical knowledge to reach conclusions from testing results, data collation, statistical analysis and arriving at the most...DataSeniorContract workFor contractorsLocal areaFlexible hours
- KBI Biopharma, Inc. is seeking a qualified individual for a role focused on the review and approval of Deviations and CAPAs to support GMP manufacturing... ...mentorship to junior QA staff. The ideal candidate... ...substantial experience in a QA cGMP regulated environment,...Senior
- .... 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
- ...JOB DESCRIPTION OVERVIEW CREO Senior Analysts in IT Compliance and Quality take on a... ...address client compliance challenges, improve data integrity, and mitigate risks. Develop... ...Please note: This application may be reviewed in part by automated systems to help identify...DataSeniorWork experience placement
- ...active reliable state to support cGMP operations. Facilities... ...Automation for the facility. A Senior Automation Engineer is responsible... ...Building Management System, and Data Historian. Support... ..., copy and fax machine KBI Biopharma, Inc. is an EEO/AA employer and...DataSeniorFor contractorsWork at officeImmediate startShift work
- ...Job Summary: Responsible for review and approval of Deviations and... ...as needed. Mentors junior QA staff in deviation/CAPA review... ...11+ years' experience in a QA cGMP regulated environment within Biopharmaceuticals... ...required. KBI Biopharma, Inc. is an EEO/AA employer...SeniorImmediate start
- Sr. Quality Specialist - cGMP Manufacturing - Weekend 1st Shift At Alcami, we deliver... ...in joining our team? Job Summary The Senior Quality Assurance Specialist is... ...procedures. These activities may include reviewing documents and data, conducting audits and inspections, hosting...DataSeniorWork experience placementWeekend workDay shift
- ...Senior Systems Software Engineer This role has been designed as ‘... ...protect, analyze, and act on their data and applications wherever they... ...As a Senior Systems Software QA Engineer, you will lead the design... ...development partners. Review and evaluate designs for compliance...DataSeniorWork experience placementWork at officeLocal areaImmediate start2 days per week
- Job Summary Responsible for review and approval of Deviations and CAPAs... ...as needed. Mentors junior QA staff in deviation/CAPA review... ...+ years of experience in a QA cGMP regulated environment within Biopharmaceuticals... ...required. EEO Statement KBI Biopharma, Inc. is an EEO/AA employer...Senior
- ...an active reliable state to support cGMP operations. The Senior Automation Engineer will provide technical... ..., Building Management Systems, and Data Historian. Plan and execute... ...copy and fax machine EEO Statement KBI Biopharma, Inc. is an EEO/AA employer and actively...DataSeniorFor contractorsWork at officeShift work
Do you want to receive more vacancies?
Subscribe and receive similar vacancies to Senior QA Reviewer, CGMP Biopharma Data. Be the first to apply!
- senior manager process engineering Durham, NC
- senior manager clinical operations Durham, NC
- senior lead project manager Durham, NC
- senior manager quality engineering Durham, NC
- senior device engineer Durham, NC
- senior full stack developer Durham, NC
- senior hvac project manager Durham, NC
- senior strategy analyst Durham, NC
- senior project manager construction Durham, NC
- senior work from home Durham, NC


