Quality Analyst - 3rd shift

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.

The Quality Analyst I Batch Release is a member of the Quality Assurance Team (QA) reporting directly to the Quality Supervisor, Batch Release. He or she is responsible for compiling all documentation required for batch manufacturing, including printing of controlled forms from Veeva for each Manufacturing batch produced in their building, generating additional controlled forms needed during the batch manufacturing process, as well as management of the process sign-out and sign-in of batch records from the Documentation Center.

This role will also be responsible for assisting employees with correction resolution and handling the executed batch record documentation while going through the correction process. This role will also have secondary responsibilities assigned to help manage the workload in the Documentation Centers. These responsibilities could include batch record review, support section review, non-batch related documentation review, controlled form reconciliation and audit trail review.

He or she provides customer service to internal customers, as well as communicates effectively with all levels of the organization.

• Perform final batch record review
• Reconcile discrepancies with documentation and/or electronic systems as appropriate.
• Compile documentation packets for batch manufacturing, including printing of controlled forms and other serialized or controlled documentation that is not part of the effective manufacturing batch record.
• As needed during operations, generate additional batch documents for batches in progress. This may include supplemental batch record sections, controlled forms, and documents of other types.
• Manage the process of sign-out and sign-in of batch records.
• Manage the process of correction resolution, assisting personnel with controlled access to executed records requiring documentation corrections.
• Facilitate an environment of teamwork and communication between Quality Assurance, Production and other support functions to ensure on-time Quality review of batch records in order to achieve internal targets and contractual commitments for batch release.
• Participate in continuous improvement projects to improve department operations, increase efficiency, solve problems, generate cost savings, improve quality, and increase employee and customer satisfaction.

• Bachelor’s degree in a science discipline or bachelor’s degree in non-science discipline with at least three years…