Overview
Quality Assurance Specialist Jobs in Rockville, MD at Cellphire Therapeutics, Inc.
Title: Quality Assurance Specialist
Company: Cellphire Therapeutics, Inc.
Location: Rockville, MD
Cellphire Therapeutics, Inc. is a Rockville, Maryland-based biotechnology company developing next-generation therapeutics. The company is applying its proprietary cell stabilization technology to all cell types, including platelets, to develop lifesaving products. Its lead product, Thrombosomes®, a freeze-dried hemostatic agent derived from human platelets, is currently in a Phase I clinical trial. Cellphire’s technology has potential applications across a wide range of medical applications from trauma to wound care, imaging, targeted drug delivery, and regenerative medicine. www.cellphire.com
Benefits That Matter
- Competitive base salary + bonus
- Equity opportunities
- Comprehensive medical, dental, and vision
- 401(k) with company match
- Generous PTO and holidays
Position Overview
The QA Associate III plays a critical role in ensuring compliance with cGMP, regulatory requirements, and internal quality systems. This position is responsible for performing advanced Quality Assurance functions including batch record review, deviation management, and quality system support. The role works cross-functionally with Manufacturing, Quality Control, and Regulatory teams to ensure product quality and operational excellence in a fast-paced biotechnology environment.
What You Will Do
- Coordinates and maintains the electronic training system.
- Review of GxP records to ensure accuracy, completeness, and compliance with ALCOA+ principles and internal procedures. Tracking and reconciliation of record inventories and error trending.
- Supplier qualification and management.
- Materials disposition
- Internal assessments of GxP functional areas and systems to ensure compliance to SOPs. Identification and communication of deficiencies and follow up to ensure mitigation.
- Line clearance and quality oversight for product manufacturing and labeling operations.
- Applies principles of continuous improvement (e.g., quality control tools, quality management and planning tools, continuous improvement methods and lean tools) to product and process development/improvement and CAPA projects.
- Updates knowledge by studying trends in the developments in quality management; participating in educational opportunities; reading professional publications; maintaining personal networks; participating in professional organizations.
- Enhances department and organization reputation by accepting ownership for accomplishing new and different requests; explores opportunities to add value to Cellphire.
Ideally, you’ll have
- Bachelor’s Science degree or Associate's degree with 2+ years of additional relevant experience
- 5+ year of QA experience
- Experience in commercial GMP organizations
- Experience in improving and maturing a company’s quality systems, project lead role a plus
- Experience ensuring and optimizing compliance with FDA regulations, specifically 21 CFR Parts 210/211 (cGMP, 21 CFR Part 600 (Biologics). Experience with 21 CFR Part 4 (Combination Products) a plus
- Experience in training management a plus
- Professional certifications in quality topics (e.g., ASQ Certification) a plus
You'll excel if you have experience with
- Biologics, cell therapy, or blood-derived products
- Sterile or aseptic manufacturing environments
- Electronic Quality Management Systems (eQMS)
- Regulatory inspections and audit support
- Continuous improvement methodologies
Pay Range USD $80,000.00 – USD $110,000.00 / Yr.
Disclaimer: Please note that job responsibilities, reporting lines, and duties outlined in this job description are subject to change to meet the evolving needs of the organization.
Cellphire is an Equal Opportunity Employer.
Thrombosomes® has not been approved or licensed by the U.S. Food and Drug Administration (FDA) but has been authorized for emergency use under an Emergency Use Authorization (EUA). The product is authorized only for the duration of the declaration that circumstances exist justifying the authorization of emergency use.
