Sr Quality Control Specialist- Children's GMP

Join Our Team!

The Children's GMP, LLC Quality Control Department is looking for someone to fulfill the role of Senior Quality Control Specialist to be a part of the assay development team within the department. The primary responsibility is to assist the assay development team by providing training, gaining proficiency in assay development protocols, contributing to the design and optimization of novel analytical assays, participating in assay qualification and validation activities, and supporting the development and characterization of assays for drug products, drug substances, in-process samples, and reagents manufactured by Children’s GMP, LLC. To be a successful member of the Quality Control team, one is expected to have strong communication and teamwork skills. 

Preferred Laboratory Skillsets: Aseptic technique, cell and tissue culture, cell-based assays for characterizing cell and gene therapy products, ELISA, dPCR, TCID50 assays, NGS experience, and flow cytometry. Strong scientific method writing and review skills preferred. 

 Preferred Experience: Familiarity with working in a cGMP environment. Quality Control Laboratory experience. Experience working in a regulated environment. Experience with GxP software systems. Experience with Microsoft Office applications. Experience with following and/or creating Standard Operating Procedures. 

 

Job Responsibilities: 

• Independently execute quality/production processes with guidance, to monitor and ensure compliance with all applicable regulatory requirements (e.g., FDA, FACT, USDA). 

• Collaborate across teams to support revision/continuous improvement of SOPs and/or process flows related to production/quality/TPQ/HAL. 

• Monitor production to ensure cGMP compliance by checking batch records for accuracy and equipment logs for completeness; address critical deviations. 

• Lead internal/external audits, investigation of deviations, and identification/implementation of corrective actions. 

• Monitor and document compliance with quality and regulatory requirements. 

• Guide/make recommendations for continuous improvement of production/quality/ compliance systems using documentation such as release specifications, variances, environmental monitoring reports, and internal audits. 

• Regularly train and oversee the work of others in quality/production regulations, systems, and SOPs. 

• Perform other duties as assigned to meet the goals and objectives of the department and institution. 

• Maintains regular and predictable attendance. 

 

Minimum Education and/or Training: 

• Bachelor's degree in chemistry, biology or a related field required. 

• Master's degree preferred. 

 Minimum Experience: 

• Experience working with quality/production systems/processes and their maintenance/implementation, as applicable to own area (e.g. cell processing, cell culture, vector production) preferred. 

• Experience working with quality/manufacturing regulations and guidelines (e.g., cGMP, cGTP, FACT) preferred. 

• Experience working with electronic systems commonly used in Quality Management Systems, preferred as applicable. 

• Experience working with computerized databases preferred as applicable.<