Quality Lab Associate I (3rd Shift)

Simtra BioPharma Solutions; Bloomington (IN); On-site; USD 42,000 - 55,000; Full time

Benefits offered by this job

Medical and Dental Coverage

Flexible Spending Accounts

Life and AD&D Insurance

401(k) Retirement Savings Plan with 회사

Paid Holidays

Paid Time Off

Paid Parental Leave

Adoption Reimbursement Program

Education Assistance

Employee Assistance Program

Employee Ownership Plan

Short and Long-Term Disability

Vision Coverage

Identity Theft Protection

Onsite Campus Amenities: Workout_facil

Job summary

Simtra BioPharma Solutions is seeking a Quality Lab Associate I in Bloomington, IN. This entry-level role performs broad laboratory testing to support the company’s quality program, reporting to a Chemistry Analytical Supervisor.

You will operate equipment like HPLC, UV, Karl Fischer, and pH/mass spectrometry, following SOPs, handling materials from raw to finished products, and ensuring data integrity and regulatory compliance.

Qualifications

• 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.

Responsibilities

• Operates applicable laboratory equipment such as HPLC, UV, Karl Fischer, pH meter, density meter, etc.
• Performs testing in accordance with applicable SOPs.
• 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 SOPs and worldwide regulatory agency requirements.
• Initiates Laboratory Investigation Reports.
• Uses the USP/EP/JP pharmacopeias.
• 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.

Skills

Attention to detail

Strong communication

Microsoft software

Education

Bachelor's degree in a physical science

Tools

HPLC

UV

Karl Fischer

pH meter

Density meter

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.

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]:

• 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.

Voluntary Self-Identification

For government reporting purposes, we ask candidates to respond to the below self‑identification survey. Completion of the form is entirely voluntary. Whatever your decision, it will not be considered in the hiring process or thereafter. Any information that you do provide will be recorded and maintained in a confidential file.

As set forth in Simtra BioPharma Solutions’s Equal Employment Opportunity policy, we do not discriminate on the basis of any protected group status under any applicable law.

If you believe you belong to any of the categories of protected veterans listed below, please indicate by making the appropriate selection. As a government contractor subject to the Vietnam Era Veterans Readjustment Assistance Act (VEVRAA), we request this information in order to measure the effectiveness of the outreach and positive recruitment efforts we undertake pursuant to VEVRAA. Classification of protected categories is as follows:

A "disabled veteran" is one of the following: a veteran of the U.S. military, ground, naval or air service who is entitled to compensation (or who but for the receipt of military retired pay would be entitled to compensation) under laws administered by the Secretary of Veterans Affairs; or a person who was discharged or released from active duty because of a service‑connected disability.

A "recently separated veteran" means any veteran during the three‑year period beginning on the date of such veteran's discharge or release from active duty in the U.S. military, ground, naval, or air service.

An "active duty wartime or campaign badge veteran" means a veteran who served on active duty in the U.S. military, ground, naval or air service during a war, or in a campaign or expedition for which a campaign badge has been authorized under the laws administered by the Department of Defense.

An "Armed forces service medal veteran" means a veteran who, while serving on active duty in the U.S. military, ground, naval or air service, participated in a United States military operation for which an Armed Forces service medal was awarded pursuant to Executive Order 12985.