Quality Technician - Environmental Monitoring (3rd shift)

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

Job summary

Simtra BioPharma Solutions in Bloomington, Indiana, is seeking a Quality Technician - Environmental Monitoring for the 3rd shift to support the Quality Assurance Line Operations group in sterile manufacturing.

You will perform routine sampling, document results in LIMS, and assist with real time risk assessments. The role requires a HS diploma, the ability to wear PPE, and lifting up to 20 lbs.

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.

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 SOPs and worldwide regulatory requirements.
• Will be required to recognize and elevate non-conformances.

Skills

Communication

Education

High school diploma or GED

Tools

Microsoft Word

Microsoft Excel

Outlook

D365

Veeva

LabWare

Job description

Quality Technician - Environmental Monitoring (3rd shift)

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 3rd shift are Monday-Thursday 10p-8:30a

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 elevate 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.