Quality Assurance III

Description

Job Title: Quality Assurance Specialist III  

Location: Houston Headquarters Facility   

Department: Quality Assurance  

Reports To: Sr. Director, Quality Assurance   

FLSA Status: Full Time/Exempt 

Mission Statement

The mission of PackGene Biotech is to accelerate gene therapy product development by providing an integrated one-stop shop solution to the gene therapy industry. We strive to make gene therapy accessible to more patients in needs.  

Gene therapy is believed to revolutionize the healthcare field in upcoming years. PackGene is well positioned to play a big role in this transformation.  

Company Background

PackGene Biotech was founded in 2014 and headquartered in Guangzhou, China. It is a leading gene therapy CRO/CDMO service provider in Asia and USA. 

PackGene is looking for highly motivated hands-on individuals to join our fast-growing Houston site. A fantastic opportunity to join a dynamic team and make a great impact! The QA Specialist ensures that PackGene’s quality standards and procedures are maintained and effectively implemented. As a team member of a dynamic QA department, this role involves monitoring compliance with cGMP requirements, and collaborating with other departments to ensure continuous improvement of the quality management system.  

Requirements

Key responsibilities

• Compliance Monitoring: Through establishing and trending relevant quality metrics (key quality indicators), monitors and ensures compliance with cGMP regulatory requirements and PackGene policies. 
• Auditing: Conducts and supports internal and external audits to assess compliance with quality management systems and regulatory requirements. Maintains an audit schedule and coordinates audit responses.  
• Document Control: Maintains the document control/archival room, the document numbering system and the generation of controlled records for GMP manufacture. Develops, reviews, and approves GMP documents. 
• Training: Maintains the training management system (LMS) and training assignment for personnel. Identifies training needs and curricula with the support of department managers.  
• Risk Management: Tracks the identification of quality compliance risks and work with relevant departments to develop mitigation strategies. 
• Continuous Improvement: Collaborates with cross-functional teams to identify and implement process improvements that enhance product quality and compliance. 
• CAPA, Deviation, Change Control Management: Oversees these processes, trending adherence to completion dates, and driving timely closure.  
• Regulatory Submissions: Assists in the preparation of regulatory submissions and responses to regulatory agency inquiries. 
• Quality Metrics: Develops and monitors key quality metrics to assess the effectiveness of quality assurance processes and drive continuous improvement. Leads quality councils or other meetings as appointed by the Head of QA.  
• Communication: Communicates quality and compliance issues to senior management and provides recommendations for improvement.  
• Exemplifies and drives a Quality Culture throughout the organization. This includes having and promoting a right-first-time mindset, respecting the procedures and policies, and striving for continuous improvement.? 
• Other duties as assigned. 

Skills and Qualifications

• Bachelor with 4+ years of experience in biotechnology, biopharmaceutical, or CDMO industry. 
• In-depth knowledge of regulatory requirements (e.g., FDA, EMA), quality management systems, auditing and industry best practices. 
• Experience authoring, reviewing and approving GMP documents. 
• Experience managing deviations, CAPAs, change controls and quality metrics.? 
• Strong analytical and problem-solving skills, excellent written and verbal communication abilities, and proficiency in quality management software and tools. 

Working Conditions

• In Office 

Physical requirements

• Crouching: Bending the body downward and forward by bending leg and spine. 
• Hearing: Perceiving the nature of sounds at normal speaking levels with or without correction and having the ability to receive detailed information through oral communication and making fine discriminations in sound. 
• Kneeling: Bending legs at knee to come to a rest on knee or knees. 
• Lifting: Raising objects of 25lbs from a lower to a higher position or moving objects horizontally from position to position. This factor is important if it occurs to a considerable degr