Inspection Operator (1st Shift)

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. 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.  

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.  We hold ourselves to the highest quality and regulatory standards.

While our primary focus is cGMP manufacturing, we offer many support services including formulation and development, lyophilization optimization, global regulatory support and secondary packaging.  Our teams are driven to help clients scale, innovate and bring life-changing medicines to patients worldwide.

 

Why join Team Simtra? Because we:

Make it HAPPEN – We bring a growth mindset to every opportunity, developing new skillsets and exceeding our expectations and those of our customers.

Make it TOGETHER – We work as one, respecting each voice and tapping into our unique strengths across teams—so we can solve problems in new ways.

Make it RIGHT – We hold ourselves to a high standard of excellence, fulfilling our commitments to the customer, their patients, and our team members.

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.

 

 

This role:

The Inspector Operator works within the Finishing/Packaging Complex. They visually inspect (manually and semi-automated) product containers, closures and contents for defects according to standard operating procedures (SOP). They are detail oriented, adhere to guidelines, and achieve goals in order to meet client demand. This role contributes to creating an environment where teamwork, productivity, safety, identity, strength, purity and quality (SISPQ) are reflected in the finished product. This position reports to the Finishing Supervisor.

 

The responsibilities:

• Manually visually inspect product in black & white booth or semi-automated inspection machine at established target rates or qualified speeds, respectively  
• Organize and segregate rejects according to category of defect  
• Count and or verify proper unit count; reconcile to count received  
• Document all current Good Manufacturing Practices (cGMP) activities at the time of performance and as required in the Batch Record or controlled forms  
• Provide support and feedback to manufacturing team to reduce/eliminate controllable defects 
• Assist with the inspection of performance qualification/validation materials, Technical Services studies, and larger scale sampling operations  
• Inspect and document results from Knapp study sample sets for validation use; provide support for results summary  
• Contribute to the inspection library when “new” defects or limit samples are discovered  
• Identify, communicate and solve problems to ensure quality, efficiency, and safety objectives are met 
• Set-up, Tear down, and Clear Inspection area  
• Participate/perform line clearance activities  
• Dispose of rejects in the appropriate disposal area following reconciliation or box rejects to return to client 
• Stage materials in the appropriate designated locations  
• Prepare paperwork for upcoming inspection(s)