Quality Technician - Environmental Monitoring

Simtra BioPharma Solutions; Bloomington (IN); On-site; USD 42,000 - 56,000; Full time

Benefits offered by this job

Medical & Dental Coverage

401(k) Retirement Savings Plan with公司匹

Time Off Program

Paid Holidays

Paid Time Off

Paid Parental Leave and more

Adoption Reimbursement Program

Education Assistance Program

Employee Assistance Program

Job summary

Simtra BioPharma Solutions in Bloomington, Indiana is seeking a Quality Technician - Environmental Monitoring to support the Quality Assurance Line Operations. This entry-level position performs routine sampling in controlled environments and processes samples in a LIMS, reporting to a QALO Supervisor.

You will help maintain data integrity, conduct real-time risk assessments of manufacturing areas, and assist in identifying non-conformances while adhering to SOPs and regulatory requirements.

Qualifications

• High school diploma or GED required.
• Prior experience preferred.
• Proficiency with MS Office and enterprise software.
• Good communication skills.

Responsibilities

• Sample controlled environments per the sampling Master Plan using aseptic technique.
• Document and process samples in a Laboratory Information Management System (LIMS).
• Perform real time risk assessments of manufacturing areas and processes.
• Maintain data integrity and ensure SOP and regulatory compliance.
• Recognize and expand non-conformances.

Skills

Communication skills

Attention to detail

Teamwork

Education

High school diploma or GED

Tools

Microsoft Word

Excel

Outlook

D365

Veeva

LabWare

Job description

Quality Technician - Environmental Monitoring

Bloomington, Indiana, United States

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 Quality Technician - Environmental Monitoring is an entry-level position in the Quality Assurance Line Operations group. This position works independently to perform routine sampling and process samples in support of the Quality department. This position reports to a Quality Line Operations (QALO) Supervisor.

The working hours for 1st shift are Monday-Thursday 6a-4:30p

The responsibilities:

• Samples controlled environments per the sampling Master Plan utilizing aseptic technique.
• Documents and processes samples in a Laboratory Information Management System (LIMS).
• Performs real time risk assessments of the manufacturing areas and process.
• Maintains data integrity and ensures compliance with company standard operating procedures (SOP’s) and worldwide regulatory requirements.
• Will be required to recognize and expand non-conformances.

Desired qualifications:

• High school diploma or GED.
• Prior experience preferred.
• Computer proficiency in Microsoft Word, Excel, and Outlook and the ability to use enterprise software (examples include: D365, Veeva, LabWare, etc.)
• Must be able to communicate well.

Physical / Safety Requirements:

• Must be able to gown qualify for Grade C/D area.
• The position sometimes requires extended periods of standing.
• Must be able to wear applicable Personal Protective Equipment.
• Duties may require overtime work, including nights, holidays, and weekends
• Use of hands and fingers to manipulate office and laboratory equipment is required
• Must be able to lift 20 lbs.
• Must be able to qualify for 20/25 corrected vision and pass color blindness test.

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.

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.

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.