Quality Supervisor - Filling (3rd shift)

Simtra BioPharma Solutions; Bloomington (IN); On-site; USD 70,000 - 90,000; Full time

Job summary

Simtra BioPharma Solutions in Bloomington, IN seeks a Quality Supervisor - Filling (3rd shift) to lead environmental monitoring and QALO oversight on the production floor. You will supervise QALO personnel, ensure regulatory compliance and drive quality initiatives across manufacturing operations.

The role focuses on safeguarding product quality, mentoring staff, and delivering timely investigations, deviations, and SOP documentation in a cGMP setting.

Qualifications

• Experience supervising quality operations in manufacturing environments.
• Strong ability to ensure regulatory compliance and cGMP adherence.
• Experience authoring and revising SOPs, batch records and related docs.
• Proven track record leading teams in high-stakes manufacturing settings.

Responsibilities

• Lead EM and QALO activities to ensure product quality and compliance.
• Hire, develop, and evaluate Quality staff, fostering continuous improvement.
• Provide rapid, quality-first decisions in collaboration with production.
• Ensure training and compliance of QALO associates and Quality Technicians.
• Author, revise, and review SOPs, batch records, and documentation as needed.

Skills

People management

Regulatory compliance

SOP development

Investigation handling

Job description

Quality Supervisor - Filling (3rd shift)

Bloomington, Indiana, United States

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.

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.

The role:

The Quality Supervisor is a member of the Quality Assurance Leadership Team reporting directly to the Senior Manager, Quality. They provide direct support to Environmental Monitoring, 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 Quality Supervisor 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 Quality Supervisor creates an environment where teamwork, productivity, safety, identity, strength, purity and quality (SISPQ) are reflected in the finished product.

The working hours for third shift are Monday-Thursday 10p-8:30a.

The responsibilities:

• Able to successfully perform all the primary responsibilities of EM and QALO personnel.
• Effectively grows, manages, develops and empowers 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 and Quality Technicians.
• Authors and approves investigation/deviation reports.
• Leads ongoing daily QALO and environmental monitoring 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 regulatory and Simtra quality requirements. Maintain a high level of expertise in current