QC Specialist I Raw Material Specifications and VCNs

KBI Biopharma•Durham, NC

13d•$55,000 - $75,900

About The Position

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. Position Summary: The QC specialist I Raw Material Specifications and Vendor Change Notifications (VCN) will provide Quality Control Support for all KBI US based sites. This support will primarily include routine cGMP operations related to the authoring of material specifications for raw materials and consumables as well as performing impact assessments to raw materials and consumables stemming from Vendor Change Notifications (VCN). The incumbent will perform daily activities to assure timely development of raw material specifications, change control management, and the material readiness program to support project timelines. This includes coordination with approved third-party laboratories and internal testing teams to ensure the appropriate methods are listed on the material specification as well as determination of the appropriate sampling amounts to complete all testing. The QC Specialist I Raw Material Specifications and Vendor Change Notifications provides exemplary service to both internal and external customers by ensuring patient safety and regulatory compliance while supporting product lifecycle activities for timely delivery of products to clients for patients. Additionally, this position acts as QCRM support for internal and external audits as well as working with clients on material specification development.

Requirements

Education: 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.
Technical skills/Abilitites Demonstrated interpersonal skills, ability to work in a team environment, high attention to detail, and strong problem resolution skills are critical for success in this position. A strong understanding and ability to interpret US, EU, and other regulatory agencies’ CGMP compendia and guidelines is necessary for the incumbent. Additionally, exceptional technical writing skills and understanding of regulatory testing requirements and the ability to understand impact due to changes in vendor processes for raw materials and consumables is required for this role.
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. Ability to effectively present information and respond to questions from groups of managers, clients, customers, and the general public.
Reasoning Ability 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.
Math Aptitude Basic math skills are required. Ability to apply concepts of basic algebra and statistics.
Computer Skills 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).

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