Quality Lab Associate , QCIS; first shift

Quality Lab Associate I, QCIS (first shift)

Bloomington, Indiana, United States

Simtra Bio Pharma Solutions (Simtra) is a world‑class Contract Development Manufacturing Organization that partners with pharmaceutical and biotech companies to bring sterile injectable products to market. We operate facilities in Bloomington, Indiana and Halle/Westfalen, Germany, offering delivery systems such as pre‑filled syringes, liquid/lyophilized vials, diluents for reconstitution, powder‑filled vials, and sterile crystallization.

Our product portfolio includes biologics and small molecules, cytotoxics, highly potent compounds, diluents for reconstitution, and vaccines—all of which are directly injected into patients worldwide. As a result, quality and continuous improvement are central to our mission. We maintain the highest quality and regulatory standards.

While our core focus is cGMP manufacturing, we also provide support services such as formulation and development, lyophilization optimization, global regulatory support, and secondary packaging.

We are driven to help clients scale, innovate, and bring life‑changing medicines to patients worldwide.

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 and know the impact we make—taking on challenges big and small to improve patient health.

This role: The Microbiology Quality Lab Associate I performs complex routine and non‑routine sampling and processes samples in support of the Microbiology department. This position reports to a Microbiology Supervisor.

• Perform testing (bioburden, sterility, growth promotion, etc.) on finished products and in‑process samples.
• Conduct investigational work for out‑of‑specification samples, leveraging training and scientific methods to identify root cause and corrective actions.
• Document and process samples in a laboratory environment.
• Investigate and author microbiology investigations.
• Enter test data into a Laboratory Information Management System (LIMS).
• Participate in continuous improvement activities.

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

• 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.

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

(1) Current benefit offerings are in effect through 12/31/24.

This job description is intended to provide the minimum knowledge, skills, and abilities required to perform the job. It may not be inclusive of all the duties and responsibilities of the job. Simtra reserves the right to make modifications based on business requirements.

Simtra is proud to be an equal‑opportunity employer. Simtra evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status, or any other legally protected characteristic. EEO is the Law.