Quality Lab Associate I - Chem Lab (Weekend PM, 7p-7a)

Simtra BioPharma Solutions•Bloomington, IN

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. This role: The Quality Lab Associate I performs entry-level laboratory testing (pH, density, volume, etc.) that requires a variety of chemical, biological, or physical analyses on products/systems in support of the company’s quality program. This role works as part of the quality unit. This position reports to a Quality Control Chemistry Supervisor.

Requirements

Bachelor’s Degree in Chemistry, or Biological Science with Analytical Chemistry or Laboratory coursework required
Computer proficiency in Microsoft Word, Excel, and Outlook and the ability to use enterprise software (examples include: JDE, BPLM, Pilgrim, Trackwise, etc.)
Must be able to wear personal protective equipment.
Duties may require overtime work, including nights, holidays, and weekends
Use of hands and fingers to manipulate office and laboratory equipment is required
Position may require sitting or standing for long periods of time.
This position requires handling of laboratory chemicals
Must be able to lift 25 lbs.
Must be able to qualify for 20/25 corrected vision and pass color blindness test

Nice To Haves

Knowledge of instrument/software/documentation repair and calibration systems preferred

Responsibilities

Operates applicable laboratory equipment (HPLC, UV, Karl Fischer, pH meter, density meter, etc.)
Performs testing in accordance with technical service studies, experimental batches and development studies
Performs raw material, in-process, and finished product testing
Maintain data integrity and ensure compliance with company standard operating procedures (SOPs) and worldwide regulatory agency requirements
Writes non-conformance reports
Initiates Laboratory Investigation Reports
Performs general laboratory/personal area clean-up
Participates in continuous improvement functions involving teams, which increase efficiency, solve problems, generate cost savings and improve quality
Performs internal laboratory checklist and audits