We are seeking a dedicated and detail-oriented QA Specialist to join our team at a contract manufacturer for mammalian cell culture protein therapeutics. The primary responsibility of this role is to oversee the QA approval of Raw Material Specifications and Vendor Change Notifications. The successful candidate will also support the QA Raw Materials team in various functions, including but not limited to:

Key Responsibilities:

• Manage the USP, EP, JP compendial update review program.
• Collaborate with and audit Warehouse processes.
• Support the dispositioning of Raw Materials for two North Carolina facilities.
• Manage client Cell Bank Inventories and chain of custody within the facility.
• Provide QA support for Raw Material and Warehouse Quality management functions (CAPA, Deviations, SOP Updates, Document Archival, etc.).
• Oversee the chain of custody management of Bulk Drug Substance shipping.
• Manage rejected or expired materials.
• Handle Vendor Complaints within the Patriot Park Facility.
• Oversee the storage and management of the QA retain program.

Qualifications:

• Bachelor's degree in a related field (e.g., Chemistry, Biology, Quality Assurance).
• Minimum of 5 years of experience in a QA role within the pharmaceutical or biotechnology industry.
• Strong understanding of USP, EP, and JP compendial requirements.
• Experience with CAPA, Deviations, and SOP management.
• Excellent organizational and communication skills.
• Ability to work collaboratively in a team environment
• Preferred experience working in QA or QC raw materials at another CDMO

Salary Range: $63,000 - $86,900

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, 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.