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.