QC Specialist I 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.

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.

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
  
  
  

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).

Salary Range: $55,000 - $75,900

Salary range provided per current averages and expectations. The salary and job title for this opening will be based on the selected candidate’s qualifications and experience and may be outside this range. KBI has a robust total rewards strategy which includes an 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 and employee recognition programs.

About KBI:

KBI Biopharma, Inc., a JSR Life Sciences company, 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. For more information, visit www.kbibiopharma.com.

KBI is a proud EEO/AA employer dedicated to building a diverse and inclusive workforce. We believe that innovation thrives in an environment where all voices are heard and valued. That's why we actively seek individuals from all backgrounds – regardless of race, color, national origin, religion, gender, gender identity, sexual orientation, age, disability, or veteran status – and strongly encourage all qualified candidates to apply and bring their unique perspectives to our team.

KBI Biopharma is committed to providing a safe and healthy workplace. Any employee entering a KBI site located in the US must inform KBI Biopharma of their vaccination status and must submit their vaccination status. All vaccinated employees are required to provide proof of their COVID-19 vaccination, with a COVID-19 vaccination which has been granted FDA approval or Emergency Use Authorization.

KBI Biopharma, Inc. is an EEO/AA employer and actively seeks to diversify its work force. Therefore, all qualified applicants, regardless of race, color, national origin, religion, gender, gender identity, sexual orientation, age, disability or veteran status, are strongly encouraged to apply.

I understand that neither the completion of this application nor any other part of my consideration for employment establishes any obligation for KBI Biopharma, Inc. to hire me. If I am hired, I understand that either KBI Biopharma, Inc. or I can terminate my employment at any time and for any reason, with or without cause and without prior notice. I understand that no representative of KBI Biopharma, Inc. has the authority to make any assurance to the contrary.

I attest with my signature below that I have given to KBI Biopharma, Inc. true and complete information on this application. No requested information has been concealed. I authorize KBI Biopharma, Inc. to contact references provided for employment reference checks. If any information I have provided is untrue, or if I have concealed material information, I understand that this will constitute cause for the denial of employment or immediate dismissal.