QC Specialist Raw Material Specifications and VCNs

At KBI Biopharma, we are advancing science and accelerating breakthroughs. As a global leader in biopharmaceutical development and manufacturing, we empower life science companies to bring new medicines and vaccines to the world faster. Explore your potential at KBI, where innovation meets impact.

The QC Specialist I Raw Material Specifications and Vendor Change Notifications supports all KBI US‑based sites. The role involves routine cGMP operations related to authoring raw material specifications and performing impact assessments related to Vendor Change Notifications (VCN). The incumbent ensures timely development of specifications, change control management, and material readiness to support project timelines.

• Draft specifications for raw materials and consumables and/or 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 client regarding material specification inquiries.
• Support relevant investigations, change controls, CAPAs, and QC‑related projects.
• Attend relevant operational meetings in support of all activities related to timely establishment of material specifications for raw materials and consumables as well as responses to VCN.

• 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 experience in regulated industry may be considered in lieu of the specified education.
• Technical skills/Abilities: Demonstrated interpersonal skills, ability to work in a team environment, high attention to detail, strong problem resolution skills. Strong understanding and ability to interpret US, EU, and other regulatory agencies’ CGMP compendia and guidelines. Exceptional technical writing skills and understanding of regulatory testing requirements.
• Language Ability: Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, or governmental regulations in English. Ability to write reports, business correspondence, and procedure manuals.
• Reasoning Ability: Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists.
• Math Aptitude: Basic math skills are required. Ability to apply concepts of basic algebra and statistics.
• Computer
  
  Skills:
  
  Word processing, database, spreadsheets, PowerPoint, Internet, e‑mail, calendar management, virtual chat, and meeting platforms. Ability to use business related software systems such as SAP.

$55,000 - $75,900

About KBI: KBI Biopharma, Inc. is a global contract development and manufacturing organization (CDMO) providing fully integrated and accelerated drug development and biologics manufacturing services to life science companies. KBI supports its 500+ customers in advancing more than 160 drug candidates from preclinical and clinical stages to market, including the manufacture of ten commercial products. Recognized for quality manufacturing, KBI delivers robust process development and cGMP manufacturing services across its six global locations in the USA and Europe.

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EEO/AA Statement: KBI is an equal opportunity employer and actively seeks to diversify its workforce. All qualified applicants regardless of race, color, national origin, religion, gender identity, sexual orientation, age, disability, or veteran status are encouraged to apply. The employment decision is based on job requirements.