Quality Lab Associate I - Chem Lab (3rd shift)

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.Why join Team Simtra? Because we: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 Lab Associate I performs entry-level laboratory testing (pH, density, volume, etc.) that requires a variety of chemical, biological, or physical analyses on products/systems in support of the company's quality program. This role works as part of the quality unit. This position reports to a Quality Control Chemistry Supervisor.The responsibilities:Operates applicable laboratory equipment (HPLC, UV, Karl Fischer, pH meter, density meter, etc.)Performs testing in accordance with technical service studies, experimental batches and development studiesPerforms raw material, in-process, and finished product testingMaintain data integrity and ensure compliance with company standard operating procedures (SOPs) and worldwide regulatory agency requirementsWrites non-conformance reportsInitiates Laboratory Investigation ReportsPerforms general laboratory/personal area clean-upParticipates in continuous improvement functions involving teams, which increase efficiency, solve problems, generate cost savings and improve qualityPerforms internal laboratory checklist and auditsThe requirements:Bachelor's Degree in Chemistry, or Biological Science with Analytical Chemistry or Laboratory coursework requiredComputer proficiency in Microsoft Word, Excel, and Outlook and the ability to use enterprise software (examples include: JDE, BPLM, Pilgrim, Trackwise, etc.)Knowledge of instrument/software/documentation repair and calibration systems preferredPhysical / safety requirements:Must be able to wear personal protective equipment.Duties may require overtime work, including nights, holidays, and weekendsUse of hands and fingers to manipulate office and laboratory equipment is requiredPosition may require sitting or standing for long periods of time.This position requires handling of laboratory chemicalsMust be able to lift 25 lbs.Must be able to qualify for 20/25 corrected vision and pass color blindness testIn return, you'll be eligible for[1]:Day One BenefitsMedical & Dental CoverageFlexible Spending AccountsLife and AD&D InsuranceSupplemental Life InsuranceSpouse Life InsuranceChild Life InsuranceShort and Long-Term Disability Insurance401(k) Retirement Savings Plan with Company MatchTime Off ProgramPaid HolidaysPaid Time OffPaid Parental Leave and moreAdoption Reimbursement ProgramEducation Assistance ProgramEmployee Assistance ProgramCommunity and Volunteer Service ProgramAdditional BenefitsVoluntary Insurance BenefitsVision CoverageAccidentCritical IllnessHospital Indemnity InsuranceIdentity Theft ProtectionLegal and moreOnsite Campus AmenitiesWorkout FacilityCafeteriaCredit Union[1] Current benefit offerings are in effect through 12/31/26#IND-USOPSDisclaimerThis 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.Equal Employment OpportunitySimtra 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 LawEEO is the law - Poster SupplementPay Transparency PolicyData PrivacyTo learn more about Simtra's approach to data privacy, please review the Simtra Recruitment Platform Global Privacy Policy:https://biopharmasolutions.baxter.com/simtra-recruitment-platform-privacy-policyCreate a Job AlertInterested in building your career at Simtra BioPharma Solutions? Get future opportunities sent straight to your email.Create alert