We use cookies to improve your experience on this website.

Deviation Investigator (cGMP – Pharmaceutical) JD817618

JD817618

DPS Engineering is looking for a capable Deviation Investigator to work with a BioPharma client in the Boston, MA area. Ideal candidates should have a strong understanding of GMPs and have previous experience working within highly regulated pharmaceutical/biotech facilities. This individual will provide direct support to Manufacturing while investigating process deviations; designing effective CAPA; developing and delivering successful training; and monitoring and measuring ongoing performance of Bulk Manufacturing quality systems.

Category:
Miscellaneous Personnel
Location:
Massachusetts
Years of Experience Req.:
4+
Date Posted:
15/02/2019
Days Remaining:
13
Employment Type:
Full-time
Education Level Req.:
Bachelors Preferred

Deviation Investigator (cGMP – Pharmaceutical)       JD817618

Boston, MA

 

Summary:

 

DPS Engineering is looking for a capable Deviation Investigator to work with a BioPharma client in the Boston, MA area. Ideal candidates should have a strong understanding of GMPs and have previous experience working within highly regulated pharmaceutical/biotech facilities.

 

This individual will provide direct support to Manufacturing while investigating process deviations; designing effective CAPA; developing and delivering successful training; and monitoring and measuring ongoing performance of Bulk Manufacturing quality systems.

 

Responsibilities:

  • Responsible for utiliz724959.550568ing knowledge of manufacturing process to thoroughly investigate deviations to procedures and specifications.
  • Drive the investigation process to successful resolution through close collaboration with Manufacturing and Quality teams.
  • Determine accurate root causes of problems and propose and implement effective CAPA to eliminate these causes.
  • Must be able to work independently with minimal supervision and direction.
  • Point of contact and owner of deviations/CAPA/Change Control.        
  • Determine long-term and short-term corrective actions (CAPA).                                    
  • Facilitate weekly deviation meeting and provide status updates on all open deviation Interview individuals involved with the event.
  • Update SOPs or other official documents as required.

 

Qualifications:

  • B.S. degree in Engineering, Chemistry, Biology or related field.
  • 3+ years' experience in a cGMP regulated Biologics or Pharmaceutical environment or equivalent experience.
  • Subject matter expertise in Cell Culture, Protein Purification or Support Services.
  • Experience with deviation or investigation management systems.
  • Relevant industry Biotechnology Manufacturing and/or Quality operations experience.
  • Ability to author and review standard operating procedures, on-the-job-trainings, and other controlled documents.
  • Expertise with Deviation Management Systems (i.e. TrackWise).
  • Experienced in troubleshooting, investigation, and root-cause analysis in a cGMP environment.
Back to top