Quality Supervisor - Filling; weekend AM Job Bloomington area,Indiana USA,Quality Assurance

Bloomington, Indiana, United States

Simtra Bio Pharma 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 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.

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…