Quality Assurance Specialist I

At iBio, we’re growing tomorrow’s biologics with ourFastPharming®Systemfor high-quality, eco-friendly production of recombinant proteins using plants. At our 130,000 square foot manufacturing facility and headquarters in Bryan, Texas, we combine vertical farming, automated hydroponics, and molecular biology to produce therapeutics, vaccines and products for life science research and bioprocessing. We’re putting these capabilities to work for our clients via our array ofcontract development and manufacturing services, as well as deploying them for the advancement of our ownpipelineof therapeutics, vaccines, and products for research & bioprocessing applications. We’ve recently expanded our footprint to San Diego where our early-stage drug discovery team is pioneering the next generation of biopharmaceuticals for the treatment of cancers, as well as fibrotic and infectious diseases.

Just imagine what we can do together! We know extraordinary things happen when individual talent, technology, and a great mission cross paths: the opportunity to create an outstanding team and a world-class company. We are looking to hire exceptional people who have demonstrated track records of success to continue to build a leading biotechnology and development services organization.

Apply now for our Quality Assurance Specialist I position and help bring the power of plants to the biopharmaceutical industry!

MISSION OF THE POSITION

TheQA Specialist I, under direction of the QA Operations Supervisor, will be responsible for review and/or approval of basic and technical documentation, drafting and reviewing of internal quality policies and procedures, assisting in and performing product related activities, identifying process and quality system improvements, and acting as a QA liaison internally and externally. They will also assure adherence to established procedures and policies needed to meet the Quality Management Systems requirements in a regulated Contract Development and Manufacturing Organization (CDMO) that produces materials for human and or veterinary therapeutic and related uses.

WORK LOCATION

The Quality Assurance Specialist I position is located in Bryan, Texas.

ESSENTIAL DUTIES & RESPONSIBILITES

• Serve as a quality assurance partner for all GxP operations.
• Evaluate data and laboratory documentation for compliance with quality system regulations (USFDA, EU, ISO, GMP, and GLP) and SOPs.
• Review batch production records for accuracy, consistency, and compliance.
• Support Deviation/OOS, CAPA, and PAR processes.
• Identify potentials areas for future process improvement initiatives.
• Support quality audits of suppliers and internal operations to address previously identified quality concerns along with any performance improvement opportunities.
• Participate in root cause analysis (RCA) for quality problems and corrective action plan.
• Ensure corrective actions are successful through verification of effectiveness (VOE) activities.
• Assist in laboratory equipment validation and calibration efforts.
• Perform QA training and proficiency evaluation to relevant practices.
• Review Protocols, SOPs, BPRs, and Forms through the established document control process.
• Archiving of documentation including BPRs, Forms, Lab Notebooks, Logbooks, etc.
• Analyze upstream and downstream quality data for key performance indicators (KPIs).
• Other responsibilities as deemed necessary.

KNOWLEDGE, SKILLS, & ABILITIES

• Working knowledge of statistical process control and statistical quality control (SPC and SQC).
• Working knowledge and cGMP/GLP regulations
• Proficient in Microsoft Office Suite
• Possess technical writing skills
• Strong written and verbal communication skills

EDUCATION & EXPERIENCE

• A technical degree (e.g., Associate of Science or Bachelor of Science in Chemistry, Biochemistry, Molecular Biology, Engineering, or related field) is preferred; however, applicants with a high school diploma will be considered for this position.
• Prior QA/cGMP experience is preferred.

Accessibility: If you need an accommodation as part of the employment process please contact Human Resources at
Phone: 979-446-0266
Email: bridget.mapes@ibioinc.com

Equal Opportunity Employer, including disabled and veterans.

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