{"schemaVersion":"jobsearcher.job.v1","id":"b736e9b28dc420c26c0d0e5d","url":"https://jobsearcher.com/jobs/b736e9b28dc420c26c0d0e5d","canonicalUrl":"https://jobsearcher.com/jobs/b736e9b28dc420c26c0d0e5d","title":"Quality Client Representative","description":"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.\nOur 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.\nWhile 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.\n\nWhy join Team Simtra? Because we:\nMake it HAPPEN – We bring a growth mindset to every opportunity, developing new skillsets and exceeding our expectations and those of our customers.\nMake 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.\nMake it RIGHT – We hold ourselves to a high standard of excellence, fulfilling our commitments to the customer, their patients, and our team members.\nMake 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.\n\nThe role:\nThe Quality Client Representative is a member of the core client team and interacts directly with clients. The Quality Client Representative is responsible for all quality aspects of the project and provides exemplary customer service to both internal and external customers by focusing on quality and compliance. This position reports to the Quality Manager.\n\nThe responsibilities:\nPrimary quality contact for assigned clients externally and internally.\nManages client project quality updates and reviews with all levels of management.\nResponsible for making and delivering accurate and timely quality decisions pertaining to client projects,\nquestions, and quality requests.\nEscalates quality issues to impacted departmental quality manager and/or Quality Director as necessary for\ncorrective action implementation.\nPartners with manager and Quality leadership staff to author, drive or approve applicable quality documents,\nas the Quality representative in a timely manner.\nPartners with Program Manager, Technical Services Representatives, Quality Control Representative and\nManufacturing Representative to coordinate projects, provide support, align facility representation, and\nprovide consistent quality information.\nRepresents Quality in required Project Client Meetings.\nUnderstands the quality and technical requirements of each project.\nMaintains Project File, including recording and tracking quality interaction with client. Track, trend, compile,\nand report client quality metrics as necessary.\nThoroughly understands the Quality Agreement, Master Batch Record (MBR), Quality Control Master\nDocument (QCMD), Regulatory and Procedural requirements that govern the client/company relationship\nand product.\nAssist and lead quality agreement contract negotiations\nIdentifies and leads continuous improvement activities to maximize business results.\n\nThe requirements:\nBachelor's degree required, preferably in a science related field with 5 years pharmaceutical industry experience or a Master's degree with 3 years of pharmaceutical experience.\nFamiliar with quality operating procedures, quality, and regulatory requirements pertinent to pharmaceutical,\nbiological and biochemical quality.\nKnowledge of worldwide regulatory requirements\nComputer proficiency in Microsoft Word, Excel, and Outlook and the ability to use enterprise software\n(examples include: D365, Veeva, Blue Mountain, Trackwise, etc.)\n\nPhysical / Safety Requirements:\nDuties may require overtime work, including nights and weekends\nUse of hands and fingers to manipulate office equipment is required\nPosition may require sitting or standing for long hours of time\n\nIn return, you'll be eligible for[1]:\nDay One Benefits\nMedical & Dental Coverage\nFlexible Spending Accounts\nLife and AD&D Insurance\nSupplemental Life Insurance\nSpouse Life Insurance\nChild Life Insurance\n401(k) Retirement Savings Plan with Company Match\nTime Off Program\nPaid Holidays\nPaid Time Off\nPaid Parental Leave and more\nAdoption Reimbursement Program\nEducation Assistance Program\nEmployee Assistance Program\nCommunity and Volunteer Service Program\nEmployee Ownership Plan\nAdditional Benefits\nShort and Long-Term Disability Insurance\nVoluntary Insurance Benefits\nVision Coverage\nAccident\nCritical Illness\nHospital Indemnity Insurance\nIdentity Theft Protection\nLegal and more\nOnsite Campus Amenities\nWorkout Facility\nCafeteria\nCredit Union\n[1] Current benefit offerings are in effect through 12/31/26\n\nDisclaimer\nThis 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.\n\nEqual Employment Opportunity\nSimtra 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.\n\nData Privacy\nTo learn more about Simtra's approach to data privacy, please review the Simtra Recruitment Platform Global Privacy Policy: https://simtra.com/privacy-policy/","company":"Simtrabiopharmasolutions","rawCompany":"simtrabiopharmasolutions","city":"Bloomington","state":"CA","isRemote":false,"isActive":false,"createdAt":"2026-08-04T22:00:41.766Z","occupations":[{"code":"19-4099.01","title":"Quality Control Analysts","slug":"quality-control-analysts"},{"code":"11-3051.01","title":"Quality Control Systems Managers","slug":"quality-control-systems-managers"},{"code":"41-4011.00","title":"Sales Representatives, Wholesale and Manufacturing, Technical and Scientific Products","slug":"sales-representatives-wholesale-and-manufacturing-technical-and-scientific-products"}],"industries":[{"code":"325412","title":"Pharmaceutical Preparation Manufacturing","slug":"pharmaceutical-preparation-manufacturing"},{"code":"325414","title":"Biological Product (except Diagnostic) Manufacturing","slug":"biological-product-except-diagnostic-manufacturing"},{"code":"325413","title":"In-Vitro Diagnostic Substance Manufacturing","slug":"in-vitro-diagnostic-substance-manufacturing"}],"jobPosting":{"@context":"https://schema.org","@type":"JobPosting","title":"Quality Client Representative","description":"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.\nOur 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.\nWhile 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.\n\nWhy join Team Simtra? Because we:\nMake it HAPPEN – We bring a growth mindset to every opportunity, developing new skillsets and exceeding our expectations and those of our customers.\nMake 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.\nMake it RIGHT – We hold ourselves to a high standard of excellence, fulfilling our commitments to the customer, their patients, and our team members.\nMake 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.\n\nThe role:\nThe Quality Client Representative is a member of the core client team and interacts directly with clients. The Quality Client Representative is responsible for all quality aspects of the project and provides exemplary customer service to both internal and external customers by focusing on quality and compliance. This position reports to the Quality Manager.\n\nThe responsibilities:\nPrimary quality contact for assigned clients externally and internally.\nManages client project quality updates and reviews with all levels of management.\nResponsible for making and delivering accurate and timely quality decisions pertaining to client projects,\nquestions, and quality requests.\nEscalates quality issues to impacted departmental quality manager and/or Quality Director as necessary for\ncorrective action implementation.\nPartners with manager and Quality leadership staff to author, drive or approve applicable quality documents,\nas the Quality representative in a timely manner.\nPartners with Program Manager, Technical Services Representatives, Quality Control Representative and\nManufacturing Representative to coordinate projects, provide support, align facility representation, and\nprovide consistent quality information.\nRepresents Quality in required Project Client Meetings.\nUnderstands the quality and technical requirements of each project.\nMaintains Project File, including recording and tracking quality interaction with client. Track, trend, compile,\nand report client quality metrics as necessary.\nThoroughly understands the Quality Agreement, Master Batch Record (MBR), Quality Control Master\nDocument (QCMD), Regulatory and Procedural requirements that govern the client/company relationship\nand product.\nAssist and lead quality agreement contract negotiations\nIdentifies and leads continuous improvement activities to maximize business results.\n\nThe requirements:\nBachelor's degree required, preferably in a science related field with 5 years pharmaceutical industry experience or a Master's degree with 3 years of pharmaceutical experience.\nFamiliar with quality operating procedures, quality, and regulatory requirements pertinent to pharmaceutical,\nbiological and biochemical quality.\nKnowledge of worldwide regulatory requirements\nComputer proficiency in Microsoft Word, Excel, and Outlook and the ability to use enterprise software\n(examples include: D365, Veeva, Blue Mountain, Trackwise, etc.)\n\nPhysical / Safety Requirements:\nDuties may require overtime work, including nights and weekends\nUse of hands and fingers to manipulate office equipment is required\nPosition may require sitting or standing for long hours of time\n\nIn return, you'll be eligible for[1]:\nDay One Benefits\nMedical & Dental Coverage\nFlexible Spending Accounts\nLife and AD&D Insurance\nSupplemental Life Insurance\nSpouse Life Insurance\nChild Life Insurance\n401(k) Retirement Savings Plan with Company Match\nTime Off Program\nPaid Holidays\nPaid Time Off\nPaid Parental Leave and more\nAdoption Reimbursement Program\nEducation Assistance Program\nEmployee Assistance Program\nCommunity and Volunteer Service Program\nEmployee Ownership Plan\nAdditional Benefits\nShort and Long-Term Disability Insurance\nVoluntary Insurance Benefits\nVision Coverage\nAccident\nCritical Illness\nHospital Indemnity Insurance\nIdentity Theft Protection\nLegal and more\nOnsite Campus Amenities\nWorkout Facility\nCafeteria\nCredit Union\n[1] Current benefit offerings are in effect through 12/31/26\n\nDisclaimer\nThis 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.\n\nEqual Employment Opportunity\nSimtra 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.\n\nData Privacy\nTo learn more about Simtra's approach to data privacy, please review the Simtra Recruitment Platform Global Privacy Policy: https://simtra.com/privacy-policy/","datePosted":"2026-08-04T22:00:41.766Z","dateModified":"2026-08-04T22:00:41.766Z","hiringOrganization":{"@type":"Organization","name":"Simtrabiopharmasolutions","sameAs":"https://jobsearcher.com"},"jobLocation":{"@type":"Place","address":{"@type":"PostalAddress","addressLocality":"Bloomington","addressRegion":"CA","addressCountry":"US"}},"identifier":{"@type":"PropertyValue","name":"JobSearcher","value":"b736e9b28dc420c26c0d0e5d"},"url":"https://jobsearcher.com/jobs/b736e9b28dc420c26c0d0e5d"}}