Overview
QC Investigator/CAPA Specialist (On-Site in College Station, TX) Jobs in United States at FUJIFILM Biotechnologies
Title: QC Investigator/CAPA Specialist (On-Site in College Station, TX)
Company: FUJIFILM Biotechnologies
Location: United States
***This is an on-site position in College Station, TX
The QC Investigator/CAPA Specialist is responsible for supporting deviation investigations to ensure accurate, thorough, and on time completion. The incumbent applies systematic and analytical root cause analysis techniques inclusive of Human and Organizational Performance principles to each investigation.
Reports to QC Compliance Officer
Work Location College Station, TX
Primary Responsibilities:
Leadership
Work collaboratively with staff and management of site functions to instill a ‘Quality Culture’ by coaching in the application of GMP Principles including the underlying rational of those principles.
Participate and support investigations for deviations and incidents.
Participate in investigations and assist in identification of root and/or contributing causes.
Ensures required management and Quality approvals on final investigations while satisfying established due dates.Facilitates corrective and preventive action (CAPA) agreement with stakeholders.
New Business Growth
Support client due diligence and Quality audits as well as regulatory inspections.
Compliance
Promptly notify Senior Management of potential quality or regulatory issues that may affect product quality or regulatory compliance.
All other duties as assigned.
Qualifications:
Master’s degree with 1+ years of related experience.
Bachelor’s degree with 3+ years of related experience; OR
3+ years of cGMP experience.
Degree in Chemistry, Engineering, Forensics, Biology or a related life sciences discipline preferred.
Experience with data integrity as applied to quality control labs preferred.
Kepner-Tregoe Methods (5 Analytical Techniques SA, PA, DA, PPA, POA).
MEEPS.
Applied Human and Operational Performance (HOP).
Facilitation skills and proven record to effectively lead cross-functional teams.
Technical writing skills and ability to synthesize information from multiple SMEs into a coherent, clear and concise narrative.
Ability to interpret technical information and documentation used for operations and production activities.
Ability to communicate effectively across organizations.
Ability to set personal performance goals and provide input to departmental objectives.
Proficient in Trackwise, Microsoft Excel, Word and PowerPoint.
Role model for company core values of trust, delighting our customers, Gemba, and Genki.
