SUMMARY:
The Quality Regulatory Documentation Specialist will have the opportunity to contribute to the overall success of a growing company. The successful candidate will play a vital role in supporting our Quality and Regulatory programs, cGXP compliance, and corporate Quality System. Our lab is a highly dynamic and exciting place to work. We offer competitive compensation packages and are located in Corona, CA
DUTIES AND RESPONSIBILITIES:
This position should be capable of supporting multiple projects with excellent organization, flexibility, and time-management. This position requires the capacity to handle multiple tasks and responsibilities, which include:
- Participate in final QA review of completed production batch records to ensure compliance with cGMP and GDP.
- Organize and compile all required documents, including test reports, for complete production batch records; work with teams to ensure that all queries are resolved and that release criteria are met.
- Participate in reviewing, updating, and maintaining our existing libraries of SOPs, forms, logs, and master batch records.
- Assist in drafting or developing new SOPs, forms, logs, and record keeping and tracking tools for quality and regulatory compliance.
- Participate in preparing new documents as required for the quality system and regulatory compliance/submissions, including reports, summaries, templates, spreadsheets, and validations.
- Implement and support GDP, process improvements, quality training, document management, document/change control, deviation management.
- Assist in tracking and documenting deviations, nonconformances, and corrective and preventive actions (CAPA).
- Participate in internal audits and investigate/document nonconformances and CAPAs as needed.
- Organize documents and draft summaries/tables based on relevant documents and data for regulatory submissions. Assist in reviewing data documentation to ensure completeness, accuracy, and compliance with quality standards.
- Compile and organize documents for record retention according to regulatory requirements.
Note: This is NOT an all-inclusive list of responsibilities.
QUALIFICATIONS:
- Bachelor's degree in basic science (cell biology, molecular biology, biochemistry), clinical science, or data science 2+ years of work experience in quality documentation (certifications are preferred) or regulatory operations in academia or preferably in biotech or pharmaceutical industry.
- Working knowledge of FDA regulations, ICH guidelines, and requirements for cGMP, GTP, GDP, and GCP compliance as they relate to quality documentation and regulatory submissions.
- Exceptional attention to detail and accuracy in documentation, as well as in oral and written communications; excellent written and spoken English.
- Experience with both paper-based documentation system and electronic documentation systems; flexibility and problem-solving skills are a plus. Working knowledge of standard scientific, analytical, and statistical principles.
- Strong organizational skills to work on multiple tasks as assigned, follow priorities, communicate, and meet timelines.
- Ability to take direction, ask questions, and work independently as instructed on tasks.
- High standards of organization, accountability, time management, integrity, and work ethic.
- Commitment to quality, accuracy, efficiency, and communication.
- Self-motivated and willing to learn and grow with a small company.
- Proficient in Microsoft Office Suite and Adobe Acrobat Pro.