Quality Technician - Environmental Monitoring; 2nd shift

Quality Technician - Environmental Monitoring (2nd shift)

Bloomington, Indiana, United States

Simtra Bio Pharma 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  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 2nd shift are Monday-Thursday 2p-12:30a

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, Lab Ware, 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
[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…