Sr. QA Inspector - Label Control (2nd Shift)

Simtra BioPharma Solutions•Bloomington, IN

11d•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. This role: The Sr. Quality Inspector (Label Control) is a member of the Finishing Quality Assurance Team reporting directly to the Quality Finishing Line Operations Supervisor. They are responsible for printing, counting, inspecting, and issuing all client specific printed materials for pharmaceutical products. They are expected to meet client demand with first pass quality using controlled documentation (batch records, Finishing Specification Sheets, Master labels, standard operating procedures) and current Good Manufacturing Practices (cGMP) guidelines. In addition, they will ensure the accuracy of inventory counts and provide training for new Label Control employees. They are expected to contribute to an environment where teamwork, productivity, safety, identity, strength, purity and quality (SISPQ) are reflected in the finished product. The working hours for this role are Monday-Friday 2:45p-11:15p

Requirements

High School diploma or GED required
Minimum 2 years experience in a pharmaceutical or biotech industry required.
Computer proficiency in Microsoft Word, Excel, and Outlook and the ability to use enterprise software (examples include: D365, Veeva, ROBAR, etc.)
Must be able to lift 50 lbs.
Must be able to qualify to 20/20 corrected vision and pass color blindness testing.
Must be able to perform physical tasks which include bending, twisting, kneeling and stooping.
Must be able to sit and stand for extended periods of time.
Must wear appropriate personal protective equipment, as applicable.
Use of hands and fingers to manipulate office equipment is required.

Nice To Haves

General knowledge of Quality and Warehouse Operations is preferred.

Responsibilities

Calculate quantity of each Printed Material required for each batch
Set up print jobs and ensure accuracy of all in-house Printed Material
Assemble all required Printed Materials and imprint devices for each batch as directed by the Finishing Specification Sheet
Document, issue, and release all Printed Materials
Return Printed Materials to inventory as appropriate
Perform resupplies of materials
Clearance of print stations
Ensure organization and maintenance of the Label Control Cage
Participate in process improvement teams for Label Control activities
Act as the first point of contact for any printed materials/Label Control issues that occur
Perform inventory cycle counts in the enterprise resource planning system.
Perform QA Checklist Assessments to ensure compliance of all areas in the Finishing department.
Crosstrain on the basic job skills for both QA Finishing Line Operations and the QA Warehouse Technician (including line clearance, AQL inspection, and Reserve Sample Inspection)