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.
Vacancy posted 1 day ago
Similar jobs that could be interesting for youBased on the Senior QA Reviewer, CGMP Biopharma Data in Durham, NC vacancy
- 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
$63k - $86k
...role is responsible to perform data review for contract services... ...analytical testing; understanding cGMP standards is recommended. Knowledge... .... Minimum Requirements Senior Research Associate: B.A or B.... ...00-$86,000 EEO Statement 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
- ...differential.Job SummaryThe QA Manufacturing... ...for on the floor review of executed records... ...all aspects of cGMP operations. Client... ...forms, in-process data, and logbooks.Perform... ...equivalent is required.MQA Senior Specialist: BS/BA... ...is preferred.KBI Biopharma, Inc. is an EEO/AA...DataSeniorWork at officeImmediate startShift workNight shift
$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 shiftKBI BioPharma
Durham, NC3 days ago$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$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- Axiom-Path is seeking a QA professional in Durham, NC, to join its high-performing team focused on enterprise applications. In this role... ...QA testing, validate document outputs, and conduct backend data verification using SQL. The ideal candidate should have significant...DataSeniorRelocation
- ...tools. 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 DATADataSeniorFlexible hours
- ...documents, policy outputs, and transactional data workflows. This environment values detail-... ..., and document generation workflows. The QA organization works closely with developers... ...using Postman and related testing tools Review application behavior, business rules, and...DataSeniorContract workRelocation
- ...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
- .... 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
Axiom Path
Durham, NC14 days ago - ## Senior AccountantApplylocations: USA - NC - Durham - Emperor Blvdtime... ...008467About this job:Join KBI Biopharma's Corporate Accounting team as... ...dynamic, mission-driven, and data-driven environment. You will... ...process development and cGMP manufacturing services across...DataSeniorContract workImmediate start
KBI BioPharma
Durham, NC3 days ago - Responsibilities Review GMP documentation (logbooks, pest control, waterlogs, calibration/maintenance... ...control final product and stability data. Process rejected lots for destruction;... ...SOPs and work instructions. Support cGMP via closure of quality events, CAPAs, and...DataSenior
- ...Asscoaite degree or Highschool Diploma with 2 years related GMP Biopharma experience Knowledge in Veeva/electronic document management... ...system. Knowledge in Archiving or organizing physical documents. Data Entry computer skills. GMP experience. Required Excellent...DataContract work
- ...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
- ...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
- 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
- Senior Automation EngineerSkip to main contentOur website uses cookies... ...reliable state to support cGMP operations. Facilities Engineering... ...Management System, and Data Historian.Support Validation with... ...telephone, copy and fax machine*KBI Biopharma, Inc. is an EEO/AA employer...DataSeniorFor contractorsWork at officeImmediate startShift work
$119k - $141k
...complex clinical development. By bringing data and teams together, we empower... ...seeking a highly skilled and analytical Senior QA Automation Engineer to drive our automation... ...Collaboration: Participate in design reviews, sprint planning, and daily stand-ups....DataSeniorTemporary workWork at officeRemote workFlexible hoursGrabJobs
Durham, NC2 days ago- 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
- ...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
- ...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
- 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
- KBI Biopharma, Inc. is seeking a Manufacturing Execution System (MES) Engineer to support ongoing operations at their biopharmaceutical facility in Durham, North Carolina. The role includes generating electronic manufacturing records, troubleshooting, and ensuring compliance...Senior
- ...Overview Our client is seeking a Senior Mechanical Engineer to lead... ...control needs, including cGMP-regulated facilities and ISO-certified... ...junior staff, lead technical reviews of critical deliverables, and... ..., battery, aerospace, or data centers (strongly preferred)....DataSeniorFor contractorsRemote workRelocation
Dalia Consulting
Durham, NC19 days ago - ...and based on medical need, with a strong focus on transparency, data-driven decision-making, and equitable outcomes. In this role... ...if any), external market and internal value analysis including seniority and merit systems, as well as internal pay alignment. Annual...DataMinimum wageFull timeContract workTemporary workWork experience placementRemote work
Maximus
Durham, NC5 hours ago
Do you want to receive more vacancies?
Subscribe and receive similar vacancies to Senior QA Reviewer, CGMP Biopharma Data. Be the first to apply!
Related searches
- senior robotics software engineer Durham, NC
- senior java software engineer Durham, NC
- senior specialist Durham, NC
- senior director clinical development Durham, NC
- senior accountant new Durham, NC
- senior support engineer Durham, NC
- senior software test automation engineer Durham, NC
- senior consulting engineer Durham, NC
- senior staff systems engineer Durham, NC
- senior dynamics crm developer Durham, NC