Inspection Operator - Shift 3

Simtra BioPharma Solutions•Bloomington, IN

12d•Onsite

About The Position

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. 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 guideline s, 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.

Requirements

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.
Visual acuity 20/20 with or without correct ive vision and ability to pass color blind test
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.

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
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)
Coordinate 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
Required to maintain attendance in accordance with the Bloomington Attendance Policy
Ensure all safety practices are followed and keep area clean and clear of hazards