--- title: 'Quality Supervisor - Filling (weekend AM) at Simtra BioPharma Solutions' canonical: 'https://feeny.ai/job/quality-supervisor-filling-weekend-am-simtra-biopharma-solutions-bloomington-7gjfg64rtmk4' type: 'job' last_seen: '2026-10-17' --- # Quality Supervisor - Filling (weekend AM) at Simtra BioPharma Solutions - **Company:** Simtra BioPharma Solutions - **Location:** Bloomington, IN - **Posted:** 2026-10-08 - **Last confirmed live:** 2026-10-17 - **Apply:** https://job-boards.greenhouse.io/simtrabps/jobs/5233388007 ## Job 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. 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 Associate III (Quality Supervisor), Quality Assurance Line Operations (QALO) is a member of the Quality Assurance Leadership Team reporting directly to the Quality Manager. They provide direct support to QALO and Manufacturing to ensure that finished products meet the required specifications by supervising QALO personnel, who provide quality oversight in the manufacturing areas. The QALO Associate III provides decision-making and oversight to ensure compliance to all regulatory agency regulations and guidelines and to Simtra Standard Operating Procedures. This position fully supports and drives quality operations on the production floor and communicates effectively with production team members, management, and other cross-functional departments. The QALO Associate III creates an environment where teamwork, productivity, safety, identity, strength, purity and quality (SISPQ) are reflected in the finished product. This position supports Weekend AM Shift: The Weekend Shift is responsible for weekends and Holidays in addition to flexible workdays on Thursday/Friday or Monday/Tuesday. The hours are from approximately 0700 to 1930 on Friday/Saturday and 0700 to 1930 on Sunday/Monday, as applicable. The work schedule is 36 hours and is considered full-time. The shift may be flexible based on business needs. The responsibilities: - Able to successfully perform all the primary responsibilities of QALO personnel (ex, providing quality oversight, chart review, etc.). - Effectively grows, manages, develops and empowers QALO personnel including hiring and evaluation of performance. - Provides rapid, quality-first decision-making in collaboration with manufacturing and other cross-functional teams. - Ensures training and compliance of QALO associates. - Authors and approves investigation/deviation reports. - Leads ongoing daily QALO activities and assist other cross-functional areas to ensure successful execution/implementation. - Ensures tasks are completed assigned to self and QALO personnel to ensure Quality and site metrics are met. - Author, revise, and review, written standard operating procedures (SOPs), batch records, and other documentation as needed to meet Corporate, Plant, Regulatory Requirements, etc. while supporting continuous improvement initiatives. - Ensure compliance with all federal, state, local and company-specific regulations related to quality of product and employee safety. - Participate and lead multiple process/product improvement projects or other focus groups, design of experiments, validations, development of new methodologies or improving existing methodologies, data generation, report development, and presentation. - Lead audit ready status efforts for assigned areas and assist other areas within the facility in understanding FDA, ISO and Baxter quality requirements. Maintain a high level of expertise in current regulatory requirements. Required qualifications: - Bachelor’s degree (preferred science discipline) and 2 years of Pharmaceutical Quality/Manufacturing or other GXP regulated industry experience, or Associate’s degree with at least 3 years of Pharmaceutical Quality/Manufacturing or other GXP regulated industry experience, or no degree with at least 5 years Pharmaceutical Quality/Manufacturing or other GXP regulated industry experience. - Minimum of 2 years of leadership experience. - Working knowledge of FDA CFR 210,211 and other applicable regulations, and Good Documentation Practices (GDP) required. - Knowledge of aseptic manufacturing processes are required. - Good interpersonal/communication/influencing/negation skills. - Computer proficiency in Microsoft Word, Excel, and Outlook and the ability to use enterprise software (examples include: Microsoft Dynamics, SAP, Veeva, TrackWise, etc.) - Strong technical, analytical, and problem-solving skills. Physical / Safety Requirements: - Must wear appropriate PPE as required for various manufacturing areas - Must be able to gown qualify for Grade A/B areas. - Duties will require overtime work, including off-shift hours and Holidays as required. - Use of hands and fingers to manipulate office equipment is required. - Position requires sitting for long hours but may involve walking or standing for periods of time. In return, you’ll be eligible for[1]: - Day One Benefits - 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 Volunteer Service Program - Employee Ownership Plan - Additional Benefits - Short and Long-Term Disability Insurance - Voluntary Insurance Benefits - Vision Coverage - Accident - Critical Illness - Hospital Indemnity Insurance - Identity Theft Protection - Legal and more - Onsite Campus Amenities - Workout Facility - Cafeteria - Credit Union [1] Current benefit offerings are in effect through 12/31/26 Disclaimer 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. ## Equal Employment Opportunity 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. Data Privacy To learn more about Simtra's approach to data privacy, please review the Simtra Recruitment Platform Global Privacy Policy:  [https://simtra.com/privacy-policy/](https://nam12.safelinks.protection.outlook.com/?url=https%3A%2F%2Fsimtra.com%2Fprivacy-policy%2F&data=05%7C02%7Ctelillard%40simtra.com%7C2a07b23ebad444facb3f08dd5108ca38%7C3e24d115ff1144459784a58e778309bd%7C0%7C0%7C638755820398709298%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=%2F%2BNVbYrMrzzt06QgaReGYHpah6Eu6lTB5aALlW2f%2F0w%3D&reserved=0) ## About Simtra BioPharma Solutions ## Company Overview - **One-liner**: Simtra BioPharma Solutions is a leading contract development and manufacturing organization (CDMO) specializing exclusively in sterile injectable products for pharmaceutical and biopharmaceutical clients. - **Entity Type**: Private (Contract Development and Manufacturing Organization) - **Headquarters**: Bloomington, Indiana, United States (with a second major facility in Halle/Westfalen, Germany) - **Founded**: Not publicly disclosed (the company references "decades of experience") - **Founders**: Not publicly available ## Core Business - **Primary industry**: Pharmaceutical contract development and manufacturing (CDMO) – sterile injectables - **Target customers**: B2B – pharmaceutical and biopharmaceutical companies seeking development and commercial manufacturing of injectable drugs - **Mission purpose**: “Make what matters” – delivering vital injectable products to patients worldwide with a focus on quality, safety, and compliance ## Products & Services - **Formulation Development**: Customized development of parenteral formulations including liquid and lyophilized presentations. - **Fill/Finish Operations**: Aseptic filling of liquid vials, lyophilized vials, and prefilled syringes. - **Analytical Services**: Comprehensive analytical development and testing to support product release and stability. - **Technology Transfer**: Seamless transfer of processes from client labs to Simtra’s cGMP facilities. - **Lyophilization Cycle Optimization**: Expertise in freeze-drying cycle development and scale-up. - **Specialized Containment**: Handling of cytotoxics, highly potent compounds, and other hazardous materials. - **Global Regulatory Support**: Assistance with regulatory submissions and compliance for distribution in over 120 countries. - **ADC Manufacturing Alliance**: Strategic partnership with MilliporeSigma (Merck KGaA) for end-to-end antibody-drug conjugate (ADC) development and manufacturing. ## Market Standing - **Valuation/Market Cap**: Not disclosed (private company) - **Key Metric**: Not publicly available (annual revenue not reported); significant recent capital investments in capacity expansion - **Notable Investors/Partners**: MilliporeSigma (Life Science business of Merck KGaA) – five-year strategic alliance for ADC manufacturing; Cook Group (seller of expansion property in Bloomington) - **Growth Signals**: - Strategic purchase of a 65-acre property with 300,000+ sq ft available space near Bloomington facility for future expansion. - Completion of a new production manufacturing building at the Halle/Westfalen campus in Germany. - Active hiring with over 100 open positions across Engineering, Operations, Development, IT, and Quality. ## Competitive Advantages - **Single-minded focus on sterile injectables**: Unlike broad-spectrum CDMOs, Simtra dedicates all expertise and facilities to injectable products. - **Deep experience across drug categories**: Cytotoxics, highly potent compounds, biologics, vaccines, small molecules, and diluents. - **Global cGMP compliance**: Both facilities operate under ISO 14001-certified manufacturing practices and strict regulatory standards. - **Full-service integration**: From early development to commercial launch (lab through launch), offering a single point of accountability. - **Track record of quality**: “Make it right the first time” culture with high standards for precision and transparency. ## Strategic Focus - **Capacity expansion**: Aggressive investments in both U.S. (Bloomington) and German (Halle) sites to meet growing demand for injectable manufacturing. - **End-to-end service expansion**: Enhancing development and pre-commercial services to shorten timelines and streamline drug launch. - **Strategic alliances**: Leveraging the MilliporeSigma partnership to capture high-growth ADC and bioconjugate market. - **Operational excellence**: Continuing to invest in state-of-the-art equipment and cross-site knowledge sharing. ## Why Work Here - **Culture**: Values-driven workplace built around four pillars: Make It Right, Make It Together, Make It Happen, Make It Count. Emphasis on quality, integrity, collaboration, and patient impact. - **Meaningful work**: Employees directly contribute to producing life-changing medicines and improving patient health. - **Growth opportunities**: The company encourages a growth mindset, skill development, and career progression. Many roles offer hands-on involvement in complex manufacturing processes. - **Remote/hybrid policy**: Some positions are remote or hybrid-eligible (e.g., Senior Recruiter in Germany with remote option, Senior Quality Systems Application Analyst remote in US). Most engineering and operations roles are on-site in Bloomington or Halle. - **Diverse workforce**: Multiple locations and international collaboration create an inclusive team environment. - **Benefits**: Not explicitly detailed in available sources, but the company promotes well-being and community impact as core employee value propositions. ## Sources 1. [Simtra BioPharma Solutions – Home](https://simtra.com/) 2. [Simtra – What We Do](https://simtra.com/what-we-do/) 3. [Simtra – Open Positions (Greenhouse)](http://job-boards.greenhouse.io/simtrabps) 4. [Simtra – Careers / Open Positions](https://simtra.com/careers/open-positions/) 5. [Simtra – Our Values](https://simtra.com/who-we-are/our-values/) ## Other roles at Simtra BioPharma Solutions - [Human Resources Business Partner](https://feeny.ai/job/human-resources-business-partner-simtra-biopharma-solutions-bloomington-8sm9zz2fk23a) — Bloomington, IN - [Foreign Trade Zone Operations Manager](https://feeny.ai/job/foreign-trade-zone-operations-manager-simtra-biopharma-solutions-bloomington-e8ck7yqf7kbe) — Bloomington, IN - [Mechaniker Pharmaproduktion](https://feeny.ai/job/mechaniker-pharmaproduktion-simtra-biopharma-solutions-halle-north-rhine-wjwez45v383q) — Halle North Rhine-Westphalia, Germany - [Principal CQV Engineer](https://feeny.ai/job/principal-cqv-engineer-simtra-biopharma-solutions-bloomington-rpe8a611pwk5) — Bloomington, IN - [Lyophilization Technician (Weekend AM Shift)](https://feeny.ai/job/lyophilization-technician-weekend-am-shift-simtra-biopharma-solutions-n7e40nwh8671) — Bloomington, IN - [Pharmaceutical Manufacturing Manager, 3rd Shift](https://feeny.ai/job/pharmaceutical-manufacturing-manager-3rd-shift-simtra-biopharma-solutions-3cjhg9q1e5hz) — Bloomington, IN - [Head (m/w/d) of Visual Inspection](https://feeny.ai/job/head-m-w-d-of-visual-inspection-simtra-biopharma-solutions-halle-north-rhine-acxb1cpe0zs2) — Halle North Rhine-Westphalia, Germany - [Specialist (m/w/d) Quality Oversight Quality Control](https://feeny.ai/job/specialist-m-w-d-quality-oversight-quality-control-simtra-biopharma-solutions-4tev291sjcx4) — Halle North Rhine-Westphalia, Germany - [Manager (m/w/d) Accounting](https://feeny.ai/job/manager-m-w-d-accounting-simtra-biopharma-solutions-halle-north-rhine-westphalia-2s8dmk30t8xr) — Halle North Rhine-Westphalia, Germany - [Quality Supervisor - Filling](https://feeny.ai/job/quality-supervisor-filling-simtra-biopharma-solutions-bloomington-05rq5bh2mcxx) — Bloomington, IN