Quality Analyst II - Quality Batch Review​/Disposition

Quality Analyst II - Quality Batch Review/Disposition

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.

The role:

The Quality Analyst II is a member of the Quality Assurance Team (QA) reporting directly to the Quality Manager or Supervisor, Quality Batch Review and Batch Release. They perform review of all quality documentation generated during filling and/or packaging operations. They must communicate effectively with customer support departments to coordinate batch review and release activities to meet internal commitments and contractual commitments.

They provide leadership and guidance to analysts with less experience and create an environment where teamwork, productivity, safety, identity, strength, purity and quality are reflected in the finished product.

The responsibilities:

• Perform batch record review and final product release / disposition for GMP batches produced at Simtra for accuracy and compliance to procedures based on regulatory requirements and internal guidelines, etc.
• Reconcile discrepancies with documentation and/or electronic systems as appropriate.
• Plan, organize, evaluate, and communicate applicable activities of designated QA batch review functions, including Quality metrics reporting.
• Initiate and Author batch record related Deviations.
• Perform verification of Hold System activities.
• Reconcile controlled forms in the Veeva system.
• 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 raised client issue resolution (conference calls, responding to batch record observations)
• Subject Matter Expert for Batch Release procedures and presenting performed batch records during client and regulatory audits as required.
• Mentor and train less experienced Batch Review/Release personnel
• Lead continuous improvement projects to improve department operations, increase efficiency, solve problems, generate cost savings, improve quality, and…