Quality Lab Associate-QCMP

Simtra BioPharma Solutions; Bloomington (IN); On-site; USD 55,000 - 75,000; Full time

Benefits offered by this job

Medical & Dental Coverage

401(k) Retirement Savings Plan with (

Time Off Program

Education Assistance Program

Job summary

Simtra BioPharma Solutions in Bloomington, IN is seeking a Microbiology Quality Lab Associate I to perform complex routine and non-routine sampling, supporting the Microbiology department under supervision.

You will test finished products and in-process samples (bioburden, sterility, growth promotion), document data in LIMS, investigate out-of-spec results, and contribute to continuous improvement in a cGMP setting.

Qualifications

• Bachelor's degree in a science field is required with preference for Microbiology.
• Experience in a GMP-regulated environment is preferred.
• Proficiency in Microsoft Word, Excel, Outlook, and enterprise software (e.g., JDE, BPLM, Pilgrim, TrackWise, LIMS).

Responsibilities

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

Skills

GMP experience

Laboratory sampling

Data entry

Team collaboration

Education

Bachelor's degree in Science (prefer Microbiology)

Tools

JDE

BPLM

Pilgrim

TrackWise

LIMS

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.