Quality Assurance Consultant

Title: Part-Time QA Consultant

Location: Philadelphia United States

Job Description:

Piper Companies is seeking a QA Consultant to join a Biotechnology company located in Philadelphia, PA through a part-time, hybrid (but primarily remote) contract. The QA Consultant will require an average of 20 hours of work per week. This role is critical to ensuring the development and execution of a Quality Management System (QMS) that not only meets but surpasses FDA and GMP regulatory standards as we advance our innovative technology toward commercialization.

Responsibilities of the QA Consultant include:

• QMS Development & Oversight: Develop, implement, and sustain Quality Management System (QMS) procedures and SOPs specifically designed for cell-derived nanoparticle (CDNP) manufacturing.
• Regulatory Compliance: Ensure all processes, materials, and documentation adhere to FDA Advanced Manufacturing Technology (AMT) regulatory requirements.
• Audit Leadership: Lead internal quality audits and coordinate team readiness for external regulatory inspections.
• Document Governance: Review and approve GMP documentation, including batch records, deviation reports, CAPAs, and change control documentation.
• Risk Assessment & Mitigation: Conduct risk assessments across manufacturing operations and the supply chain to proactively identify and mitigate quality risks.
• Quality Advisory Support: Provide strategic quality and quality-by-design (QbD) guidance to Technical Operations and R&D teams.

Qualifications for the QA Consultant include:

• Education: Bachelor's or Master's degree in Biology, Biotechnology, Chemistry, or a closely related scientific discipline.
• Experience: 7-10+ years of progressive experience in Quality Assurance and/or Quality Control within the biopharmaceutical industry, with emphasis on cell therapies or biologics.
• Regulatory Expertise: Demonstrated hands-on experience with FDA and EMA regulations, including GMP compliance requirements for Advanced Therapy Medicinal Products (ATMPs).
• Core Competencies: Strong analytical and critical-thinking skills, exceptional attention to detail, and the ability to interpret complex regulatory requirements into efficient, practical procedures.
• Adaptability & Growth Experience: Proven success working in startup or high-growth environments, including building or scaling a QMS from early-stage development through clinical readiness.

Compensation for the QA Consultant includes:

• Pay Rate: $75-90/hour
• Comprehensive Benefits: Medical, Dental, Vision, 401k, Sick Leave as required by law

Keywords: quality assurance, consultant, QA, QA consultant, biotech, biotechnology, QMS development, CDNP, FDA, AMT, GMP, CAPA, risk assessment, quality by design, biology, chemistry, quality control, QC, ATMP

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