Quality Assurance Specialist

Packgene Biotech•Houston, TX

7d•Onsite

About The Position

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. The QA Specialist serves as an experienced Quality Assurance representative supporting GMP manufacturing operations, quality systems, batch disposition activities, and client programs. The role provides independent quality oversight and makes or escalates risk-based quality decisions to ensure manufacturing activities are performed in accordance with approved procedures, cGMP requirements, regulatory expectations, and internal quality standards. The QA Specialist will partner closely with Manufacturing, QC, PM, Logistics, and other functions to proactively identify and resolve quality issues, support timely execution of manufacturing operations, and maintain a state of inspection readiness.

Requirements

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.

Responsibilities

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.