KBI Biopharma Senior QA Specialist, Supplier Quality Management in Boulder, Colorado
Job Summary:Assures that suppliers and raw materials are suitable for their intended usein the manufacture of clinical and commercial biologics bulk drug substance.Responsible for compliance with regulations, procedures, and systems thatgovern the supplier approval and material qualification programs. Supportsclient audits and regulatory inspections.Job Description:Category Owner for chemicals, cell culture media suppliers, and othersuppliers as assigned.Manage the company wide supplier change management program.Lead for new supplier and material requests for Durham, N.C. and TheWoodlands, TX sites.Assist in the management of the material qualification program.Initiate and manage supplier complaints to completion.Initiates and owns Deviations, CAPA's, and Change Controls asappropriate. Works directly with manufacturing, testing labs, and otherdepartments responsible for cGMP activities around raw materials to resolvedeviations and other compliance issues in a timely manner.Negotiate and maintain supplier Quality Agreements.Drive continuous improvement efforts through facilitating, leading, andcollaborating with internal cross functional teams and suppliers.Perform routine and for-cause supplier audits as assigned (25%).Job Requirements:Bachelor's degree and 8 years' experience or Master's and 6 years'experience in a QA or cGMP environment in Biopharmaceuticals or equivalent,including previous pharmaceutical supplier quality experience.Experience performing cGMP internal audits and/or supplier audits. Auditorcertification (CQA or equivalent) preferred..Inter and intra departmental project management experience and experience withelectronic document management systems desired.Ability to travel up to 25%.KBI Biopharma, Inc. is an EEO/AA employer and actively seeks to diversifyits work force. Therefore, all qualified applicants, regardlessof race, color, national origin, religion, gender, genderidentity, sexual orientation, age, disability or Vietnam veteranstatus, are strongly encouraged to apply.