Quality Assurance Specialist

Quality Assurance Specialist

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.

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.

The QA Specialist will support manufacturing operations for our customers at the new cGMP facility in Houston TX designed to manufacture clinical stage gene therapies.

Key responsibilities include:

• Review and approve Quality System records, including deviations, change controls, CAPAs, investigations, risk assessments, and other quality records, ensuring appropriate root cause analysis, impact assessment, corrective actions, and timely closure.
• Develop, review, and approve GMP documentation, including SOPs, manufacturing records, forms, protocols, reports, specifications, and other controlled documents, as assigned.
• Review executed batch records and associated GMP documentation for completeness, accuracy, compliance, and adherence to approved procedures and applicable regulatory requirements.
• Perform QA-on-the-floor activities to provide real-time Quality oversight of manufacturing operations, including observation of critical operations, review of documentation, assessment of GMP practices, and resolution or escalation of quality issues.
• Provide Quality oversight of aseptic processing and other critical GMP operations, as applicable, ensuring compliance with established procedures, contamination control requirements, and applicable regulatory expectations.
• Support material disposition/release activities, including review of applicable documentation and confirmation that established Quality requirements have been met.
• Serve as a primary Quality Assurance point of contact for manufacturing operations, providing timely, independent, and risk-based Quality guidance and decisions within the individual's assigned authority. Escalate significant quality or compliance risks to Quality leadership as appropriate.
• Lead or actively participate in Quality review boards and cross-functional discussions related to deviations, CAPAs, change controls, investigations, batch disposition, and other quality matters.
• Provide guidance to cross-functional teams during deviation investigations, including event assessment, product and process impact evaluation, root cause analysis, CAPA development, and determination of appropriate Quality actions.
• Assess quality events and proposed changes for potential impact to product quality, patient safety, validated state, regulatory commitments, and GMP compliance.
• Communicate and collaborate directly with customers regarding quality events, investigations, changes, documentation, batch disposition activities, and other Quality matters impacting their programs, ensuring timely and professional communication.
• Lead and coordinate batch record review and batch disposition activities, ensuring all required manufacturing documentation, testing, deviations, investigations, and other applicable Quality requirements are satisfactorily completed prior to final disposition by the authorized Quality representative.
• Support review and approval of manufacturing-related protocols and reports, including validation, qualification, media fill/aseptic process simulation, and other GMP studies, as assigned.
• Participate in internal audits, client audits, and regulatory inspections, including preparation activities, document review, SME support, observation response, and follow-up actions, as assigned.
• Monitor quality trends and metrics and identify recurring issues, compliance risks, and opportunities for continuous improvement.
• Provide coaching and guidance to Manufacturing and other cross-functional personnel regarding cGMP requirements, good documentation practices, deviation management, and Quality expectations.
• Provide peer training and mentorship to less experienced Quality Assurance personnel, as appropriate.
• Exemplify and promote a strong Quality Culture throughout the organization by demonstrating Quality ownership, sound judgment, a right-first-time mindset, adherence to procedures and policies, proactive identification of risk, and commitment to continuous improvement.
• Maintain a state of inspection readiness within assigned areas and proactively identify and address potential compliance gaps.
• Other duties as assigned.

Skills and qualifications include:

• Bachelor's degree in Biology, Biotechnology, Engineering, Chemistry, Pharmaceutical Sciences, or related scientific discipline with at least 4–8+ years of relevant experience in the biopharmaceutical, biotechnology, pharmaceutical, or related regulated industry.
• Direct experience supporting GMP manufacturing operations in a QA capacity.
• Experience supporting biologics, sterile manufacturing, viral vectors, cell and gene therapy, or other complex biological manufacturing is strongly preferred.
• Experience authoring, reviewing and approving GMP documents.
• Experience reviewing and/or managing deviations, CAPAs, change controls, investigations, risk assessments and quality metrics.
• Experience performing batch record review and supporting batch disposition/release activities.
• Experience providing QA-on-the-floor support and making real-time Quality decisions within a GMP manufacturing environment.
• Strong working knowledge of cGMP regulations and regulatory expectations applicable to pharmaceutical and biologics manufacturing, including applicable FDA requirements and industry guidance.
• Experience interacting directly with customers, auditors, and/or regulatory inspectors is preferred.
• High level of integrity, accountability, attention to detail, and commitment to product quality and patient safety.

Working conditions include:

• In Office

Physical requirements include:

• 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.