Quality Analyst Lead- Batch Review

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. This role: The Quality Batch Release Lead ensures the roles and functions of the Quality Assurance (QA) Batch Release department are performed in accordance with regulatory agency rules and guidelines and Baxter quality procedures. The group performs batch record review and finished product disposition for all GMP batches produced at Baxter. This role provides customer service to internal and external customers, as well as participates in escalated client issue resolution, and lead in the development of customer awareness activities. The supervisor also provides leadership and guidance to direct reports and creates an environment where teamwork, productivity, safety, identity, strength, purity and quality are reflected in the finished product. This position reports to a Quality Manager, QA Documentation Center.

Requirements

Bachelor’s degree in a science discipline with 2 years experience in Pharmaceutical Quality or Manufacturing, or Bachelor’s degree in non-science discipline with 4 years of Pharmaceutical Quality or Manufacturing experience
Knowledge of aseptic manufacturing processes preferred.
Computer proficiency in Microsoft Word, Excel, and Outlook and the ability to use enterprise software (examples include: JDE, BPLM, Pilgrim, Trackwise, etc.)
Must wear appropriate personal protective equipment as applicable.
Duties will require overtime work, including nights and weekends
Use of hands and fingers to manipulate office equipment is required
Position requires sitting for long hours, but may involve walking or standing for periods of time.

Responsibilities

Perform final batch record review and disposition of batches.
Reconcile discrepancies with documentation and/or electronic systems as appropriate.
Compile documentation packets for batch manufacturing.
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 real 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