Quality Technician - Environmental Monitoring (weekend AM)

Simtra BioPharma Solutions•Bloomington, IN

2d•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 Quality Technician - Environmental Monitoring is an entry-level position in the Quality Assurance Line Operations group. This position works independently to perform routine sampling and process samples in support of the Quality department. This position reports to a Quality Line Operations (QALO) Supervisor.

Requirements

High school diploma or GED.
Computer proficiency in Microsoft Word, Excel, and Outlook and the ability to use enterprise software (examples include: D365, Veeva, LabWare, etc.)
Must be able to communicate well.
Must be able to gown qualify for Grade C/D area.
The position sometimes requires extended periods of standing.
Must be able to wear applicable Personal Protective Equipment.
Use of hands and fingers to manipulate office and laboratory equipment is required
Must be able to lift 20 lbs.
Must be able to qualify for 20/25 corrected vision and pass color blindness test.

Nice To Haves

Prior experience preferred.

Responsibilities

Samples controlled environments per the sampling Master Plan utilizing aseptic technique.
Documents and processes samples in a Laboratory Information Management System (LIMS).
Performs real time risk assessments of the manufacturing areas and process.
Maintains data integrity and ensures compliance with company standard operating procedures (SOP’s) and worldwide regulatory requirements.
Will be required to recognize and escalate non-conformances.