Specialist Deviation Investigations

Specialist Deviation Investigations KBI Biopharma - 2.6 Boulder, CO Job Details Full-time 1 day ago Qualifications Quality control corrective actions Pharmaceutical regulatory compliance Corrective and preventive actions (CAPA) GMP Mid-level Continuous improvement Investigative reports Quality systems Data collection Manufacturing Root cause analysis Cross-functional collaboration Escalation handling Cross-functional communication Full Job Description Job Summary Conducts investigations into manufacturing deviations, documenting findings, determining root causes, and recommending corrective and preventive actions (CAPAs). Supports quality system programs. Job Responsibilities Support cGMP manufacturing operations for manufactured biopharmaceutical products.

Responsibilities include:

Conducts investigations, including data gathering, interviews, and analysis of deviations. Documents investigation findings, root causes, and CAPAs. Applies investigation techniques and problem-solving skills to identify root causes. Identifies and escalates complex issues. Supports the implementation and effectiveness checks of CAPAs. Maintains a working knowledge of GMP and regulatory requirements. Supports quality systems programs (deviations, CAPA, continuous improvement). Collaborates effectively with cross-functional teams Works on a range of deviations with varying complexity. 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.