Quality Analyst II - Batch Record Review and Release

Simtra BioPharma Solutions•Bloomington, IN

About The Position

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. The role: The Quality Analyst II Batch Reviewer is a member of the Quality Assurance Team (QA) reporting directly to the Quality Supervisor or Manager of Quality Assurance Batch Review. He or she performs review of all quality documentation generated during filling and/or packaging operations, as well as all quality documentation required to ensure compliance of critical systems impacting the processing and disposition of product lots. He or she must communicate effectively with customer support departments to coordinate batch review and release activities to meet internal commitments and contractual commitments. He or she also provides leadership and guidance to associates with less experience and create an environment where teamwork, productivity, safety, identity, strength, purity and quality are reflected in the finished product.

Requirements

Bachelor’s degree (preferably in a science discipline) with 2 years of experience in Pharmaceutical Quality or Manufacturing, or Master’s degree (preferably in science discipline) with 1 year of Pharmaceutical Quality or Manufacturing experience
Demonstrated understanding of Quality Assurance in an FDA-regulated environment and aseptic processing operations.
Effective organizational, technical and problem solving skills
Computer proficiency in Microsoft Office and Outlook and the ability to use enterprise software (examples include: Veeva, Microsoft D365, Trackwise, etc.)
Must wear appropriate PPE as required for various manufacturing areas
Duties may require overtime work, including nights and weekends
Use of hands and fingers to manipulate office equipment is required
Position may require standing for long periods of time.

Responsibilities

Perform batch record review 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.
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.
Subject Matter Expert for Batch Review procedures and presenting executed batch records during client and regulatory audits as required.
Perform final batch record review, product release / disposition of GMP batches produced at Simtra
Plan, organize, evaluate, and communicate applicable activities of designated QA batch release functions.
Perform documentation review to ensure the compliance of critical systems impacting the processing and disposition of product lots. Perform daily, weekly systems release as defined in governing procedures. Hold systems release as appropriate until all quality requirements are met.
Reviews documentation related to critical systems, including master change control, Engineering work orders, Quality Control Critical Systems testing results, and Sterility Assurance validation and confirmation summary reports, and monitors until closure
Mentor and train less experienced Batch Review personnel
Lead continuous improvement projects to improve department operations, increase efficiency, solve problems, generate cost savings, improve quality, and increase employee and customer satisfaction.