Who we are

TheBioBox, LLC/Restem, LLC is dedicated to the responsible discovery and development of cell-based therapeutics, with an active laboratory engaged in scientific research, development of investigational products for clinical studies, and cell-derived products for cosmetic applications. We strive to facilitate biotechnology innovation and lead development of new approaches to treat degenerative disease and injury.

The Position

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

Job Description

· Title: Quality and Regulatory Documentation Specialist

· Employment Type: Full Time/Salary

· Travel: 0-10%

Responsibilities

The Quality and Regulatory Documentation Specialist will contribute as a member of the Quality team at TheBioBox, LLC/ Restem, LLC. The Documentation Specialist will support all aspects of quality and regulatory documentation, quality system implementation, document management, and change control to ensure that the documentation system, procedures, and records meet quality standards and regulatory requirements. This includes drafting, reviewing, and revising standard operating procedures (SOPs), forms, logs, and templates for compliance with internal standards, guidelines, and applicable regulations – particularly FDA 21 CFR 210, 211, 820, 1271, cGTP, GDP, and GMP and ICH.

The ideal candidate will have knowledge and experience with quality and regulatory documentation, deviation management, and all aspects of document preparation, maintenance, and record keeping to support the quality system, GDP, and GMP compliance for biopharmaceutical industry. The ideal candidate should have knowledge and interest in general biology, cell biology, cell-based therapeutic or cosmetic products, biotechnology/biologics manufacturing, quality control, and quality assurance. The successful candidate should have an aptitude for communicating professionally and collaboratively with scientists and regulators, and promoting awareness and adherence to regulations, quality standards, GDP, and GMP.

This position requires meticulous attention to detail; technical writing proficiency; the ability to draft, review, and revise quality and regulatory documents according to guidelines and templates; and strong competency in using Microsoft Office, particularly Word, Excel, and PowerPoint. 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 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.

Who You Are

Requirements

We are looking for a highly motivated candidate with experience in Quality and Regulatory documentation. The candidate should be dedicated, meticulous, organized, attentive to detail, and capable of working effectively with complexity. This position requires clear communication, flexibility, accountability, time management, organization, commitment to quality, and ability to take direction well while working on multiple projects and deadlines. The candidate should have prior experience in Regulatory or Quality Assurance with focus on documentation for biopharmaceutical industry.

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.

TheBioBox, LLC is an equal opportunity employer.

The BioBox, LLC

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Quality and Regulatory Documentation Specialist