Specialist, Quality Control (QC) Raw Materials

Summary:This individual will be responsible for activities associated with incoming inspection, sampling and external testing of raw materials and consumables used for clinical manufacturing and continuing routine cGMP operations. Author policies, procedures, and other quality documentation related to incoming inspection and sampling of raw materials and consumables. Support vendor / supplier qualification process, supplier / vendor quality related investigations and material qualifications. Participates in change controls, CAPAs and other cGMP or quality system activities related to incoming inspection, external testing and sampling of raw material and consumables. Collaborates with QA Raw Materials, Manufacturing, Supply chain and other internal stakeholders as needed to achieve site, operational and department specific goals. Cultivates and maintains Quality culture. Responsibilities:Support the introduction and qualification for in-house Raman spectroscopy testingPerform activities associated with QC oversight of external testing of raw materials, including preparation of contract lab documentation, coordination and tracking of sample and test status with contract laboratoriesAuthors policies, SOPs and other quality documentation associated with incoming inspection, sampling and external testing of raw materials and consumables. Support Deviations, CAPAs, Change Controls and Projects related to incoming inspection, sampling and external testing of raw materials and consumables.Supports vendor / supplier and material qualification activities related to raw materials and consumables. Attends operational meetings in support of inspection, sampling and testing of material / consumable. Supports client audits and regulatory inspections as required. Other activities as assigned by Management. Minimum Requirements:Bachelor''s degree and 3+ years'' experience or Master''s degree and 1+ years'' experience in a Quality Control (QC) or cGMP environment in Biopharmaceuticals or equivalent. Demonstrated strong interpersonal skills, ability to work in a team environment, attention to details and excellent problem resolutions skills. Strong understanding of FDA, EU and ROW cGMP regulations is required.Experience in QA Manufacturing Operations, Quality Control or Quality Control Incoming Inspection of materials for cGMP use and related Quality systems in a clinical or commercial manufacturing environment is beneficial.Raman spectroscopy knowledge preferredInstrument qualification/method validation experience preferredSalary Range: $50,000 - $65,000 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. KBI Biopharma, Inc. (KBI) is committed to providing a safe and healthy workplace. Any employee entering a KBI site located in the US must either (1) have provided proof of full vaccination (as defined by the CDC) with a COVID-19 vaccination which has been granted FDA approval or Emergency Use Authorization; or (2) perform weekly COVID-19 testing with negative test results.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.

Created: 2025-11-01