QC Senior Specialist Raw Materials

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:

This individual will provide Quality Control oversight and support for raw material specification development and authoring, raw material testing and third-party laboratories related to testing.  The individual will be knowledgeable in the sampling, release, and management of raw materials and testing requirements consistent will multi-national compendia and will ensure third-party testing methods are correctly identified on the specifications.  The individual will support change control pertaining to raw material specifications and material readiness in support of project timelines. This role will also be responsible for raw materials related vendor change notifications (VCN) assessments, compendial update assessments. Manage daily activities and workload to assure timely inspection, sampling and testing of raw materials and consumables to meet manufacturing needs, batch disposition dates, and project priorities. This role will be the SME for deviations and CAPAs as well as projects, including, but not limited to material qualifications, creation of new specifications, or revision of existing specifications.  This role will act as the QC Raw Materials SME for internal and external audits.

Responsibilities:

• Author/review/approve specifications for raw materials and consumables

• Perform change control activities to ensure material specifications are drafted/updated in accordance with established timelines

• Track status of samples and receive/review/approve test results from contract laboratories.  Respond to LIR events following internal procedures

• Support Compendia review and Vendor Change Notification processes

• Attend relevant operations meetings in support of manufacturing operations and material disposition.  Interface with internal and external customers to support client audits and regulatory inspections

• Interface with the client regarding material specification inquiries

• Supports relevant investigations, change controls, CAPAs, and QC-related projects

Requirements: 

• BS and 6 years of experience in a GMP regulated environment within the biopharmaceutical industry.

• Experience with raw material testing, test methods, and the requirements for establishment of specifications is required for this role. 

• A strong understand of US, EU, and other regulatory agencies requirements along with ability to interpret regulatory compendia is necessary.

• Experience working in quality management systems such as deviation and change control is also required

Salary Range: $101,000-138,600

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. 

Please note: Our pre-employment drug screening includes substances that are legal in Colorado but remain illegal under federal law, such as marijuana. A positive result for these substances may result in disqualification from employment consideration.

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