KBI Biopharma
QC Specialist I Raw Material Specifications and VCNs
KBI Biopharma, Durham, North Carolina, United States, 27703
Position Summary
QC Specialist I Raw Material Specifications and Vendor Change Notifications (VCN) provides quality control support for all KBI US based sites. Responsibilities include authoring raw material specifications, performing impact assessments for vendor change notifications, ensuring timely development of specifications, managing change control, and supporting material readiness programs. Responsibilities
Draft specifications for raw materials and consumables and draft assessments for VCNs. Perform change control activities to ensure material specifications are drafted/updated in accordance with established timelines. Interface with internal and external customers to support client audits and regulatory inspections as required. Interface with clients regarding material specification inquiries. Support relevant investigations, change controls, CAPAs, and QC‑related projects. Attend relevant operational meetings to support timely establishment of material specifications and responses to VCNs. Qualifications
Education: Bachelor’s degree in a scientific discipline or related field with 2+ years of experience, or Associate’s degree with 4+ years of experience. Commensurate regulated industry experience may be considered in lieu of specified education. Technical: Strong understanding of US, EU, and other regulatory CGMP compendia and guidelines; exceptional technical writing skills; ability to interpret regulatory testing requirements and assess impact of vendor changes. Interpersonal: Demonstrated teamwork, high attention to detail, and strong problem‑resolution skills. Language: Proficient in reading, analyzing, and interpreting professional journals and regulations; effective written communication skills. Reasoning & Math: Ability to solve practical problems and apply basic algebra and statistics. Computer: Proficiency with Microsoft office apps, SAP, and virtual collaboration tools. Salary & Benefits
Salary range: $55,000 – $75,900 annually. Additional benefits include annual bonus structure, comprehensive medical/dental/vision coverage, paid PTO and holidays, 401(k) matching with 100% vesting in 60 days, and employee recognition programs. About KBI Biopharma
KBI Biopharma, Inc. is a global contract development and manufacturing organization (CDMO) providing fully integrated drug development and biologics manufacturing services. KBI supports over 500 customers and manufactures more than 10 commercial products worldwide. EEO Statement
We are a proud EEO/AA employer dedicated to building a diverse and inclusive workforce. All qualified applicants, regardless of race, color, national origin, religion, gender identity, sexual orientation, age, disability or veteran status, are strongly encouraged to apply.
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QC Specialist I Raw Material Specifications and Vendor Change Notifications (VCN) provides quality control support for all KBI US based sites. Responsibilities include authoring raw material specifications, performing impact assessments for vendor change notifications, ensuring timely development of specifications, managing change control, and supporting material readiness programs. Responsibilities
Draft specifications for raw materials and consumables and draft assessments for VCNs. Perform change control activities to ensure material specifications are drafted/updated in accordance with established timelines. Interface with internal and external customers to support client audits and regulatory inspections as required. Interface with clients regarding material specification inquiries. Support relevant investigations, change controls, CAPAs, and QC‑related projects. Attend relevant operational meetings to support timely establishment of material specifications and responses to VCNs. Qualifications
Education: Bachelor’s degree in a scientific discipline or related field with 2+ years of experience, or Associate’s degree with 4+ years of experience. Commensurate regulated industry experience may be considered in lieu of specified education. Technical: Strong understanding of US, EU, and other regulatory CGMP compendia and guidelines; exceptional technical writing skills; ability to interpret regulatory testing requirements and assess impact of vendor changes. Interpersonal: Demonstrated teamwork, high attention to detail, and strong problem‑resolution skills. Language: Proficient in reading, analyzing, and interpreting professional journals and regulations; effective written communication skills. Reasoning & Math: Ability to solve practical problems and apply basic algebra and statistics. Computer: Proficiency with Microsoft office apps, SAP, and virtual collaboration tools. Salary & Benefits
Salary range: $55,000 – $75,900 annually. Additional benefits include annual bonus structure, comprehensive medical/dental/vision coverage, paid PTO and holidays, 401(k) matching with 100% vesting in 60 days, and employee recognition programs. About KBI Biopharma
KBI Biopharma, Inc. is a global contract development and manufacturing organization (CDMO) providing fully integrated drug development and biologics manufacturing services. KBI supports over 500 customers and manufactures more than 10 commercial products worldwide. EEO Statement
We are a proud EEO/AA employer dedicated to building a diverse and inclusive workforce. All qualified applicants, regardless of race, color, national origin, religion, gender identity, sexual orientation, age, disability or veteran status, are strongly encouraged to apply.
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