Upstream/Downstream Manufacturing Investigator II - Randstad Enterprise : Job Details

Upstream/Downstream Manufacturing Investigator II

Randstad Enterprise

Job Location : Durham,NC, USA

Posted on : 2024-09-29T16:38:03Z

Job Description :

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.

Apply Now!

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