KBI Biopharma · 1 day ago
QC Specialist I Raw Material Specifications and VCNs
Durham, NC
Full-time
Onsite
Entry Level
$55K/yr - $76K/yr
2+ years expKBI Biopharma is a global leader in biopharmaceutical development and manufacturing, empowering life science companies to bring new medicines and vaccines to market faster. The QC Specialist I will provide Quality Control support for KBI's US-based sites, focusing on authoring material specifications and performing impact assessments related to Vendor Change Notifications. This role involves ensuring patient safety and regulatory compliance while supporting product lifecycle activities.
BiopharmaBiotechnologyHealth CareManufacturing
Responsibilities
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
Qualification
Required
Bachelors degree in a scientific discipline or related field with 2+ years of experience or Associates Degree in a scientific discipline or related field with 4+ years of experience
Commensurate experience in regulated industry with strong understanding of compendial requirements, analytical testing, and change control may be considered in lieu of the specified education requirements
Demonstrated interpersonal skills, ability to work in a team environment, high attention to detail, and 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
Ability to understand impact due to changes in vendor processes for raw materials and consumables
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
Ability to effectively present information and respond to questions from groups of managers, clients, customers, and the general public
Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists
Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form
Basic math skills are required
Ability to apply concepts of basic algebra and statistics
Word processing, Database, Spreadsheets, Power Point, Internet, E-mail, Calendar Management, Virtual chat, and meeting platform (such as Microsoft Teams)
Ability to use Business related software systems (such as SAP)
Benefits
Annual bonus structure for all employees
Medical, dental, and vision coverage
Paid PTO and holidays
Sabbatical program
401K matching with 100% vesting in 60 days
Employee recognition programs
Company
KBI Biopharma
KBI Biopharma, Inc. (KBI) is a leading development and contract manufacturing organization serving the biopharmaceutical industry. We help
1001-5000 employees
H1B Sponsorship
KBI Biopharma has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (27)
2024 (11)
2023 (18)
2022 (26)
2021 (14)
2020 (21)
Funding
Current Stage
Late StageTotal Funding
$109.47MKey Investors
JSR
2025-10-01Corporate Round· $99.87M
2016-12-08Series Unknown
2009-09-22Series Unknown· $9.6M
Leadership Team
Peter Carbone
Chief Operating Officer
Sigma Mostafa
Chief Scientific Officer
Recent News
Kalaris Therapeutics, Inc.
2025-11-14
Company data provided by crunchbase