Signature Biologics, as part of a suite of emerging biotechnology and research companies, focuses on the development and commercialization of regenerative based products. We have significant clinical experience working with human perinatal biologics internationally and we are currently developing products in the US.

Essential Duties and Responsibilities:
The QA Specialist III is responsible for providing quality oversight over the production of cell therapy to support clinical and commercial requirements in the facility that is a sterile GMP environment. This position will serve as a technical leader in the implementation of Signature Biologics Quality Systems. This position is a site-based position in Irving, TX.

Key Responsibilities:

• Provide Quality oversight to Deviations, Change Controls, CAPAs, New Product Introductions (NPIs), Quality Control Assays and Batch Records (BRs) to ensure that manufactured products are of high quality, tested, stored, and distributed according to current Good Manufacturing Practices (cGMP) and other applicable regulations.
• Support investigations into quality system issues as owner or approver.
• Review released documentation for all manufacturing activities executed in accordance with Good Documentation Practices (GDP).
• Disposition of batches which includes maintaining a batch release tracking system, partnering with other functions to close all required deliverables to support the disposition of batches, which includes but not limited to executed batch records, deviations, change controls and Environmental Monitoring reports.
• Represent the QA department in internal and external meetings related to batch release to ensure quality requirements are met. Review, revise, or draft Standard Operating Procedures (SOPs) in relation to the batch release process.
• Track and trend metrics for QA on Deviations, CAPAs, and Change Controls monthly for Senior Management.
• Identify compliance gaps during internal and external site audits
• Mentor and train less experienced staff members
• Perform other duties as assigned.

Education and/or Work Experience Requirements:

• Minimum Bachelor's degree in a life science required.
• Minimum 3-5 years of cGMP experience in QA or Manufacturing with an emphasis in Cell and Gene Therapy.
• Strong GMP compliance knowledge including knowledge of 21CFR210, 211, 820 and the PICS Guide to Good Manufacturing Practices Part 1 and 2 or the EU Guidelines to Good Manufacturing Practice Medicinal Products for Human and Veterinary Use, including Annex 1.; ICH Q7, 13485 and Part 11 compliance knowledge
• Previous experience using GMP Quality Systems (ex. TrackWise, MasterControl) preferred.
• Demonstrated proficiency of written and verbal communication skills (including technical writing and presentations) with ability to communicate and collaborate effectively with technical and senior management staff.
• Ability to multi-task and prioritize responsibilities.
• Proven effective teamwork skills: able to adapt to diverse interpersonal styles.
• Excellent computer proficiency (MS Office – Word, Excel and Outlook)
• Must be able to work under pressure and meet deadlines, while maintaining a positive attitude and providing exemplary work product.
• Ability to exercise judgment for defined practices and policies in selecting methods and techniques for obtaining solutions.
• Ability to make sound decisions regarding compliance-related issues with moderate supervision.
• Ability to evaluate compliance issues and interact with regulatory inspectors.
• Gowning qualification will be required.

Physical Requirements:

• Ability to lift 50 lbs. and work in controlled space laboratory environment.
• Ability to climb ladders to reach high sampling sites.
• Ability to reach above the shoulder and bend to be able to gown.
• Ability to wear full level 3 gowning for extended periods to support EM monitoring in Cleanrooms.
• Must be able to work while standing for extended periods.