Quality Lab Associate , QCIS; first shift

Overview

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.

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.

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.

• 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.

• 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.).

• 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 benefits including Day One Benefits such as Medical & Dental Coverage, Flexible Spending Accounts, Life and AD&D Insurance, Supplemental Life Insurance (spouse and child options), Short and Long-Term Disability Insurance, 401(k) with Company Match, Time Off Program (Paid Holidays, Paid Time Off, Paid Parental Leave and more), Adoption Reimbursement, Education Assistance, Employee Assistance, Community and Volunteer Service, and Additional Voluntary Insurance Benefits (Vision, Accident, Critical Illness, Hospital Indemnity, Identity Theft Protection) as well as onsite campus amenities (Workout Facility, Cafeteria, Credit Union).

Note:

Current benefit offerings are in effect through 12/31/24.

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 duties and responsibilities. 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. EEO is the Law. EEO is the law - Poster Supplement. Pay Transparency Policy.

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