Inspection Operator - Shift

About the company

Simtra Bio Pharma Solutions (Simtra) is a world‑class Contract Development Manufacturing Organization, partnering with pharmaceutical and biotech companies to bring 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.

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

Shift: 3 hours, 10:45 PM – 6:45 AM

• Manually visually inspect product in black & white booth or semi‑automated inspection machine at established target rates or qualified speeds.
• 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 or 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 inspections.
• Coordinate material on‑time delivery and pick‑up with internal and external warehouse personnel.
• Track/document time out of refrigeration (TOR) upon movement of product to and from controlled storage so as not to exceed specified limits.
• Maintain attendance in accordance with the Bloomington Attendance Policy.
• Work schedule M‑F, 10 hours per day with additional overtime as required.
• Visual acuity 20/20 with or without corrective vision and ability to pass color‑blind test.
• Ensure all safety practices are followed and keep area clean and clear of hazards.

Controlled pharmaceutical environment including wearing long sleeves, safety toe shoes, gloves and safety glasses. Ability to work on a focused task independently for specific durations of time.

• Ability to work independently.
• Good communication skills.
• Good documentation skills, including legible handwriting.
• Good interpersonal skills.
• Basic computer skills.
• Basic math skills.
• Knowledge of SOPs, specifications and job‑specific training materials.
• Requires the operation of handheld light meters and basic packaging materials such as pallet wrappers and tape guns.

• Occasional (0‑33%) – walking, climbing stairs and ladders, reaching overhead, balancing, kneeling, crouching, crawling, lifting up to 38 lbs, carrying up to 30 lbs.
• Frequent (34‑66%) – sitting, standing, reaching forward, object handling, fingering, fine hand coordination, simple and firm hand grasping, operating controls, lifting and carrying up to 32 lbs, pushing and pulling up to 16 lbs.
• Constant (67‑100%) – object handling, fingering, fine hand coordination, simple hand grasping, firm hand grasping.
• Final candidates for Inspection Operator will be required to pass a post‑offer/pre‑employment job placement examination testing physical capabilities to perform the essential functions of the job.

• Education:
  
  High…