Quality Lab Associate - QCIS

About Simtra BioPharma Solutions

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, small molecules, cytotoxics, highly potent compounds, diluents for reconstitution, and vaccines—all directly injected into patients worldwide. We hold ourselves to the highest quality and regulatory standards and emphasize continuous improvement.

While our primary focus is cGMP manufacturing, we offer support services such as 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 Simtra?

• Make it HAPPEN – We bring a growth mindset to every opportunity, developing new skillsets and exceeding expectations.
• Make it TOGETHER – We work as one, respecting each voice and leveraging unique strengths across teams to solve problems innovatively.
• Make it RIGHT – We uphold a high standard of excellence, fulfilling commitments to customers, patients, and team members.
• Make it COUNT – We take pride in our work, knowing our efforts—big or small—improve patient health.

Responsibilities

• Performs testing (bioburden, sterility, growth promotion, etc.) on finished products and in-process samples.
• Performs investigational work for out-of-specification samples, using training and scientific methods to identify root causes and corrective actions.
• Documents and processes samples in a laboratory environment.
• Investigates and authors Microbiology investigations.
• Enters test data into the Laboratory Information Management System (LIMS).
• Participates in continuous improvement activities.

Requirements

• Bachelor’s degree required in a science-related field, preferably Microbiology.
• Previous experience working in a GMP-regulated environment preferred.
• Computer proficiency in Microsoft Word, Excel, and Outlook, with the ability to use enterprise software (e.g., JDE, BPLM, Pilgrim, Trackwise).

Physical / Safety Requirements

• Must be able to wear applicable Personal Protective Equipment.
• Position requires handling of laboratory chemicals.
• Duties may require overtime work, including nights and weekends.
• Use of hands and fingers to manipulate office equipment is required.
• Position requires sitting or standing for long hours.

Benefits

• Day One Benefits:
  • Medical & Dental Coverage
  • Flexible Spending Accounts
  • Life and AD&D Insurance
  • Supplemental Life Insurance (Spouse, Child)
  • 401(k) Retirement Savings Plan with Company Match
  • Time Off Program (Paid Holidays, Paid Time Off, Paid Parental Leave)
  • Adoption Reimbursement Program
  • Education Assistance Program
  • Employee Assistance Program
  • Community and Volunteer Service Program
  • Employee Ownership Plan
• Additional Benefits:
  • Short and Long-Term Disability Insurance
  • Voluntary Insurance Benefits (Vision, Accident, Critical Illness, Hospital Indemnity)
  • Identity Theft Protection
  • Legal Services
• Onsite Campus Amenities:
  • Workout Facility
  • Cafeteria
  • Credit Union

Current benefit offerings are in effect through 12/31/26.