Inspection Operator - Shift 3

About the role

Simtra BioPharma Solutions (Simtra) is a Contract Development Manufacturing Organization that partners with pharmaceutical and biotech companies to bring their sterile injectable products to market. Located in Bloomington, Indiana, US and Halle/Westfalen, Germany, Simtra offers a wide range of delivery systems and product types, including biologics and small molecules, cytotoxics, highly potent compounds, diluents for reconstitution, powder-filled vials, and sterile crystallization. The company holds itself to the highest quality and regulatory standards, focusing on cGMP manufacturing while offering support services like formulation and development, lyophilization optimization, global regulatory support, and secondary packaging.

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 in the Batch Record or controlled forms
• Provide support and feedback to manufacturing team to reduce/eliminate controllable defects
• Absorb and 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)
• Cook off material on-time material 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

Qualifications

• Maintain attendance in accordance with the Bloomington Attendance Policy
• Work schedule M-F, 10 hours per day with additional overtime as needed
• Ability to work independently
• Good communication skills
• Good documentation skills, including legible handwriting
• Good interpersonal skills
• Basic computer skills
• Basic math skills
• Knowledge of standard operating procedures, specifications, and job-specific training materials
• Requires the operations of handheld light meters and basic packaging materials such as pallet wrappers and tape guns

Physical / Safety Requirements

• Occasional (0-33%): Walking, climbing stairs and ladders, reaching overhead, balancing, kneeling, crouching, crawling
• Frequent (34-66%): Sitting, standing, reaching forward, object handling, fingering, fine hand coordination, simple and firm hand grasping, operating controls
• Constant (67-100%): Object handling, fingering, fine hand coordination, simple hand grasping, firm hand grasping

Desirable Qualifications

• High School diploma or GED
• 6 months of previous Pharmaceutical or Manufacturing experience preferred
• Must be able to understand, speak, read and write English in order to comply with necessary SOP, job-specific training materials, GMP’s, and other manuals

Additional Requirements

• Education and experience: High School diploma or GED, 6 months of previous Pharmaceutical or Manufacturing experience preferred
• Language skills: Must be able to understand, speak, read and write English in order to comply with necessary SOP, job-specific training materials, GMP’s, and other manuals

Pay

Details on pay are not specified in the job posting.

Schedule

Shift 3 Hours: 10:45PM-6:45AM