Randstad Enterprise is seeking an experienced Biomanufacturing Investigator to join the team! The Majors Investigator II will support Large-Scale Biomanufacturing to ensure thorough investigations and resolutions to minor deviations. Collaborating cross-functionally with positive end results and the implementation of solutions/CAPAs that optimize operations.
*Temp to perm contract position with great opportunity for conversion.
*Monday to Friday 8am to 5pm | 100% onsite in Durham (RTP).
Main Focus:
Thorough deviations and identifying the best method for corrective actions
Facilitating investigation team meetings
Conducting interviews and collecting data in order to identify causes
Investigate non batch related non conformances to determine root cause and corrective and preventive action.
Documents investigation findings and related actions in alignment with requirements and governing safety regulations
Collaborates cross-functionally with effective communication to ensure robust investigation conclusions, effective communication, and sharing of learnings
Qualified candidates will have:
A true understanding of root cause Investigation and analysis
Knowledge of manufacturing processes and its equipment
A practical knowledge of current regulations and cGMP
Education Requirements and Minimum Experience:
A.S./B.S. in engineering, Organizational Psychology, Industrial Safety, Forensics or a related scientific discipline
3 years of experience with Bachelor's
5 years of experience with A.S.
Other needed Knowledge and Skills:
Knowledge of investigation technical writing; skills in Microsoft Office; Good understanding of cGMP and regulations; Knowledge of aseptic filling; Fundamental working knowledge of enterprise systems (TrackWise)
Demonstrated experience in systematic cause analysis methods, including Event & Causal Factor charting, Logic Fault Tree and similar techniques.
Strong technical writing skills and ability to synthesize information from multiple SMEs into a coherent, clear and concise narrative.