Quality Lab Associate I (3rd Shift)

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.

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The role:

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

The responsibilities:

• Operates applicable laboratory equipment such as HPLC, UV, Karl Fischer, pH meter, density meter, etc.
• Performs testing in accordance with applicable Standard Operating Procedures (SOP’s).
• Performs testing on raw material lots, in-process products, and finished product batches as required on the associated documentation.
• Maintains data integrity and ensures compliance with company SOP’s and worldwide regulatory agency requirements.
• Initiates Laboratory Investigation Reports.
• Uses the US, EU, and Japan pharmacopeias (USP, EP and JP).
• Participates in continuous improvement activities that increase efficiency, solve problems, generate cost savings, and improve quality,
• Performs internal laboratory checklist and audits.
• Perform general laboratory/personal area clean-up.

The requirements:

• Bachelors degree in a physical science required
• Accurate and thorough with attention to detail.
• Work in a courteous and professional manner with interior and exterior clients.
• Strong communication skills, verbal, non-verbal and written, are required.
• Computer proficiency in Microsoft software programs and the ability to learn and use enterprise software.

Physical / Safety Requirements:

• Must be able to wear personal protective equipment.
• Duties may require overtime work, including nights and weekends.
• Use of hands and fingers to manipulate office 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 qualify for 20/40 corrected vision.

In return, you’ll be eligible for[1]:

• Day One Benefits
  • Medical & Dental Coverage
  • Flexible Spending Accounts
  • Life and AD&D Insurance
  • Supplemental Life Insurance
    • Spouse Life Insurance
    • Child Life 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
  • Employee Ownership Plan
• Additional Benefits
  • Short and Long-Term Disability Insurance
  • 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 12/31/26

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Disclaimer

This job description is intended to provide the minimum knowledge, skills and abilities necessary 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.

Equal Employment Opportunity

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.

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