Simtra BioPharma Solutions

Simtra BioPharma Solutions

Inspection Operator - Shift 3

Bloomington, Indiana, United States

Sponsorship not specifiedDetected 12 days ago
GMP

About the role

  • Simtra BioPharma Solutions (Simtra) is a world-class Contract Development Manufacturing Organization, partnering with pharmaceutical and biotech companies to bring their sterile injectable products to market.
  • Our product types include biologics and small molecules, cytotoxics, highly potent compounds, diluents for reconstitution and vaccines - which are all directly injected into patients worldwide.
  • As such, there is a strong emphasis on quality and continuous improvement at Simtra.

Responsibilities

  • Provide support and feedback to manufacturing team to reduce/ eliminate controllable defects
  • Inspect and document results from Knapp study sample sets for validation use; provide support for results summary
  • Participate/perform line clearance activities
  • Make it HAPPEN - We bring a growth mindset to every opportunity, developing new skillsets and exceeding our expectations and those of our customers.

Requirements

  • Document all current Good Manufacturing Practices (cGMP) activities at the time of performance and as required in the Batch Record or controlled forms

Benefits

  • Make it COUNT - We take pride in our day-to-day work, knowing the impact we make - taking on challenges big and small to improve patient health.

Company info

  • With facilities in Bloomington, Indiana, US and Halle/Westfalen, Germany, we offer a wide range of delivery systems including pre-filled syringes, liquid/lyophilized vials, diluents for reconstitution, powder-filled vials and sterile crystallization.
  • While our primary focus is cGMP manufacturing, we offer many support services including formulation and development, lyophilization optimization, global regulatory support and secondary packaging.

This listing is sourced directly from Simtra BioPharma Solutions's careers page and normalized into a canonical job model.