Senior Quality Assurance Specialist

 The Senior Quality Assurance Specialist will participate in all SIGA QA activities to ensure GMP compliance. The candidate will closely work with internal departments as well as the contract manufacturing organizations to communicate SIGA requirements. In particular, this individual will be responsible for performing high level QA document review of executed batch records, release and stability testing data, validation, and other contract manufacturer documentation to ensure compliance with regulator agency requirements and commitments. The position will also have responsibility to manage the review and approval of contract manufacturer documentation related to manufacturing, such as master batch records, material specifications, test methods, stability and validation protocols and reports, etc. This individual must have the ability to interpret contractor documentation, provide expert advice and resolve issues in support of the company daily business activities, as it relates to regulator guidelines and represent SIGA's compliance standards in interactions with internal departments as well as contract manufacturers. He or she may participate in person-in-plant activities, internal audits as well as regulatory inspections. As a Senior QA specialist this individual will work independently and have responsibility to use his or her discretion when reviewing contactor documentation and use independent judgment in making decisions that may impact the company. 

Requirements: B.S. in a scientific discipline. A minimum of 10 years experience in the pharmaceutical or biotech industry, with at least 5 years in Quality Assurance with a focus on technical document and batch record review. The ideal candidate has excellent attention to detail, good written and oral communication skills, a technically strong background in the area of manufacturing or analytical method development with the ability to work independently. Experience in validation and deviation resolution is desired. 

About SIGA

SIGA designs and develops novel countermeasures to prevent and treat serious infectious diseases, with an emphasis on biological warfare defense. SIGA is now considered a leading drug development company in the biodefense arena. Its portfolio of existing drug candidates and its platform for developing additional countermeasures against potential agents of biological warfare are intended to fill a critical need for safe and effective treatment. 

SIGA is an Equal Opportunity Employer.