Quality Lab Associate - QCIS

Simtra-Biopharma-Solutions; Bloomington (IN); On-site; USD 48,000 - 70,000; Full time

Benefits offered by this job

Medical coverage

Dental coverage

401(k) matching

Paid time off

Parental leave

Education assistance

Employee assistance program

Onsite amenities

Job summary

Simtra BioPharma Solutions in Bloomington, IN, seeks a Microbiology Quality Lab Associate I to perform complex sampling and testing in support of the Microbiology department. This role reports to a Microbiology Supervisor.

Responsibilities include bioburden, sterility, and growth promotion testing, documenting results, and contributing to investigations and continuous improvement efforts.

Qualifications

• Bachelor's degree in science required; Microbiology preferred.
• GMP regulated environment experience preferred.
• Proficient with Word, Excel, Outlook and enterprise software.

Responsibilities

• Perform testing such as bioburden, sterility, and growth promotion on products and in-process samples.
• Investigate out-of-specifications using root-cause analysis and corrective actions.
• Document and process samples in the LIMS and laboratory systems.
• Author microbiology investigations and maintain data integrity.
• Enter test results into the Laboratory Information Management System (LIMS).
• Participate in continuous improvement activities.

Skills

GMP compliance

Laboratory sampling

Data entry

Education

Bachelor's degree in science (Microbiology preferred)

Tools

JDE

BPLM

Pilgrim

Trackwise

Job description

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.

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 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.

The responsibilities:

• Performs testing (bioburden, sterility, growth promotion, etc.) on finished products and in process samples.
• Performs investigational work in support of out of specification samples, using training and scientific method to identify root cause and corrective actions.
• Documents and processes samples in a Laboratory environment.
• Investigates and authors Microbiology investigations.
• Enter test data into Laboratory Information Management System (LIMS)
• Participate in continuous improvement activities.

Required qualifications:

• 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 and the ability to use enterprise software (examples JDE, BPLM, Pilgrim, Trackwise, etc.)

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.

In return, you’ll be eligible for:

• 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

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.

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.