PackGene Biotech lnc
Quality Assurance III
PackGene Biotech lnc, Houston, Texas, United States, 77246
Job Type
Full-time
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 OfficePhysical 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 degree and requires the substantial use of the upper extremities and back muscles.Pulling: Using upper extremities to exert force in order to draw, drag, haul or tug objects in a sustained motion.Pushing: Using upper extremities to press against something with steady force in order to thrust forward, downward or outward.Reaching: Extending hand(s) and arm(s) in any direction.Repetitive motions: Making substantial movements (motions) of the wrists, hands, and/or fingers.Sitting: Sitting for a period of time.Standing: Remaining upright on the feet, particularly for sustained periods of time. ?????Stooping: Bending body downward and forward by bending spine at the waist.Talking: Expressing or exchanging ideas by means of the spoken word; those activities where detailed or important spoken instructions must be conveyed to other workers accurately, loudly, or quickly.?Walking: Moving about on foot to accomplish tasks, particularly for long distances or moving from one work site to another.The worker is required to have close visual acuity to perform an activity such as: preparing and analyzing data and figures; transcribing; viewing a computer terminal; extensive reading; visual inspection involving small defects, small parts, and/or operation of machines (including inspection); using measurement devices; and/or assembly or fabrication of parts at distances close to the eyes.
Full-time
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 OfficePhysical 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 degree and requires the substantial use of the upper extremities and back muscles.Pulling: Using upper extremities to exert force in order to draw, drag, haul or tug objects in a sustained motion.Pushing: Using upper extremities to press against something with steady force in order to thrust forward, downward or outward.Reaching: Extending hand(s) and arm(s) in any direction.Repetitive motions: Making substantial movements (motions) of the wrists, hands, and/or fingers.Sitting: Sitting for a period of time.Standing: Remaining upright on the feet, particularly for sustained periods of time. ?????Stooping: Bending body downward and forward by bending spine at the waist.Talking: Expressing or exchanging ideas by means of the spoken word; those activities where detailed or important spoken instructions must be conveyed to other workers accurately, loudly, or quickly.?Walking: Moving about on foot to accomplish tasks, particularly for long distances or moving from one work site to another.The worker is required to have close visual acuity to perform an activity such as: preparing and analyzing data and figures; transcribing; viewing a computer terminal; extensive reading; visual inspection involving small defects, small parts, and/or operation of machines (including inspection); using measurement devices; and/or assembly or fabrication of parts at distances close to the eyes.