<p>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.</p> <p>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.</p> <p>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.</p> <p>Why join Team Simtra? Because we:</p> <p>Make it HAPPEN - We bring a growth mindset to every opportunity, developing new skillsets and exceeding our expectations and those of our customers.</p> <p>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.</p> <p>Make it RIGHT - We hold ourselves to a high standard of excellence, fulfilling our commitments to the customer, their patients, and our team members.</p> <p>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.</p> <p>The role:</p> <p>The Microbiology Quality Lab Associate performs complex routine and non-routine sampling and processes samples in support of the Microbiology department. This position reports to a Microbiology Supervisor.</p> <p>The responsibilities:</p> <ul> <li>Performs complex testing (sterility, endotoxin, etc.) on finished products and in-process samples. </li><li>Performs investigational work in support of out of specification samples, using training and scientific method to identify root cause and corrective actions; authors investigations. </li><li>Documents and processes samples in a Laboratory environment utilizing LIMS. </li><li>Participate in continuous improvement activities. </li><li>Analyze data, author studies, and lead projects </li></ul> <p>Desired qualifications:</p> <ul> <li>Bachelor's degree required in a science-related field, preferably Microbiology. </li><li>Minimum of 2 years experience working in a GMP regulated environment required. </li><li>Computer proficiency in Microsoft Word, Excel, Outlook and the ability to use enterprise software such as LIMS </li><li>Experience with Endotoxin testing is desired. </li></ul> <p>Physical / Safety Requirements:</p> <ul> <li>Must be able to wear applicable Personal Protective Equipment. </li><li>Position requires handling of laboratory reagents. </li><li>Duties may require overtime work, including nights and weekends </li><li>Use of hands and fingers to manipulate office equipment is required </li></ul> <p>In return, you'll be eligible for[1]:</p> <ul> <li> <p>Day One Benefits</p> </li><li> <p>Medical & Dental Coverage</p> </li><li> <p>Flexible Spending Accounts</p> </li><li> <p>Life and AD&D Insurance</p> </li><li> <p>Supplemental Life Insurance</p> </li><li> <p>Spouse Life Insurance</p> </li><li> <p>Child Life Insurance</p> </li><li> <p>Short and Long-Term Disability Insurance</p> </li><li> <p>401(k) Retirement Savings Plan with Company Match</p> </li><li> <p>Time Off Program</p> </li><li> <p>Paid Holidays</p> </li><li> <p>Paid Time Off</p> </li><li> <p>Paid Parental Leave and more</p> </li><li> <p>Adoption Reimbursement Program</p> </li><li> <p>Education Assistance Program</p> </li><li> <p>Employee Assistance Program</p> </li><li> <p>Community and Volunteer Service Program</p> </li><li> <p>Employee Ownership Plan</p> </li><li> <p>Additional Benefits</p> </li><li> <p>Voluntary Insurance Benefits</p> </li><li> <p>Vision Coverage</p> </li><li> <p>Accident</p> </li><li> <p>Critical Illness</p> </li><li> <p>Hospital Indemnity Insurance</p> </li><li> <p>Identity Theft Protection</p> </li><li> <p>Legal and more</p> </li><li> <p>Onsite Campus Amenities</p> </li><li> <p>Workout Facility</p> </li><li> <p>Cafeteria</p> </li><li> <p>Credit Union</p> </li></ul> <p>[1] Current benefit offerings are in effect through 12/31/25</p> <p>Disclaimer</p> <p>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.</p> <p>Equal Employment Opportunity</p> <p>Simtra is 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.</p> <p>Know Your Rights: Workplace Discrimination is Illegal | U.S. Equal Employment Opportunity Commission</p> <p>Data Privacy</p> <p>To learn more about Simtra's approach to data privacy, please review the Simtra Recruitment Platform Privacy Policy:</p> <p>Privacy Policy - Simtra BioPharma Solutions</p>