Sr. QA Inspector - Line Operations (3rd Shift)

Simtra BioPharma Solutions•Bloomington, IN

17h•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. Why join Team Simtra? Because we: Make it HAPPEN – We bring a growth mindset to every opportunity, developing new skillsets and exceeding our expectations and those of our customers. Make it TOGETHER – We work as one, respecting each voice and tapping into our unique strengths across teams—so we can solve problems in new ways. Make it RIGHT – We hold ourselves to a high standard of excellence, fulfilling our commitments to the customer, their patients, and our team members. Make it COUNT – We take pride in our day-to-day work, knowing the impact we make – taking on challenges big and small to improve patient health. The role: The Sr. Quality Inspector (Line Operations) is a member of the Finishing Quality Assurance Team reporting directly to the Quality Finishing Line Operations Supervisor. They are responsible for ensuring an acceptable quality level (AQL) for all GMP products produced on the finishing lines. In addition, they are expected to be able to effectively make risk-based quality decisions for issues that occur online. They are expected to contribute to an environment where teamwork and productivity are encouraged, and safety, identity, strength, purity, and quality (SISPQ) are reflected in the finished product. The working hours for this role are Monday-Friday 10:45p-6:45a

Requirements

High School diploma or GED required
Minimum 2 years of 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 visually inspect product including 20/20 corrected vision and passing a colorblindness test.
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.
Duties will require overtime work, including nights, weekends, and Holidays.
Use of hands and fingers to manipulate office equipment is required.

Responsibilities

Monitor product quality through the performance of AQL inspections.
Perform unit and packaging level visual inspections to ensure conformance with specifications.
Perform required calculations for AQL Sampling Plans based on ANSI Standards.
Provide Quality Assurance support on the production lines.
Crosstrain on the basic job skills for both QA Label Control and QA Warehouse Technician (including release of labeling materials and Reserve Sample Inspection) and all other cross training as deemed appropriate by management.