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Quality Control Specialist IV

2 months ago

Houston, Texas, United States PackGene Biotech, Inc. Full time

The Quality Assurance Analyst plays a crucial role in ensuring that PackGene Biotech, Inc.'s quality benchmarks and protocols are upheld and effectively executed. As an integral member of a proactive QA team, this position entails overseeing adherence to current Good Manufacturing Practices (cGMP) and collaborating with various departments to foster ongoing enhancements in the quality management framework.

Key Responsibilities

  • Compliance Oversight: Establishes and analyzes pertinent quality metrics to monitor and guarantee adherence to cGMP regulations and PackGene policies.
  • Audit Support: Facilitates and participates in both internal and external audits to evaluate compliance with quality management systems and regulatory standards. Maintains an audit schedule and coordinates responses to audit findings.
  • Document Management: Oversees the document control and archival processes, including the document numbering system and the creation of controlled records for GMP operations. Responsible for the development, review, and approval of GMP documentation.
  • Training Coordination: Manages the training management system and assigns training to personnel. Identifies training requirements and develops curricula in collaboration with department leaders.
  • Risk Assessment: Monitors the identification of quality compliance risks and collaborates with relevant departments to formulate mitigation strategies.
  • Process Improvement: Works with cross-functional teams to identify and implement enhancements that improve product quality and compliance.
  • Management of CAPA, Deviations, and Change Controls: Oversees these processes, ensuring adherence to timelines and driving timely resolutions.
  • Regulatory Documentation: Assists in the preparation of submissions to regulatory bodies and responses to inquiries from regulatory agencies.
  • Quality Metrics Development: Creates and tracks key quality metrics to evaluate the effectiveness of quality assurance processes and promote continuous improvement. Leads quality councils or other meetings as designated by the Head of QA.
  • Effective Communication: Relays quality and compliance concerns to senior management and provides actionable recommendations for enhancements.
  • Promotes a culture of quality throughout the organization, emphasizing a right-first-time approach, adherence to procedures and policies, and a commitment to continuous improvement.
  • Additional responsibilities as assigned.

Qualifications and Skills

  • Bachelor's degree with a minimum of 4 years of experience in the biotechnology, biopharmaceutical, or contract development and manufacturing organization (CDMO) sectors.
  • Comprehensive understanding of regulatory standards (e.g., FDA, EMA), quality management systems, auditing processes, and industry best practices.
  • Proven experience in authoring, reviewing, and approving GMP documentation.
  • Experience in managing deviations, CAPAs, change controls, and quality metrics.
  • Strong analytical and problem-solving capabilities, along with excellent written and verbal communication skills, and proficiency in quality management software and tools.

Working Conditions

  • Office-based environment.

Physical Requirements

  • Ability to crouch, kneel, lift objects up to 25 lbs, pull, push, reach, and perform repetitive motions.
  • Capable of sitting and standing for extended periods.
  • Effective hearing and communication skills for detailed instructions and interactions.
  • Close visual acuity for tasks such as data analysis, reading, and inspection.