GMP Quality Assurance Specialist

Job Description

The Biologics Quality Assurance Auditor provides critical compliance and quality improvement support for phase 1/2a Investigational New Drug biologics manufacturing and facility operations. Working closely with the Quality Assurance Manager, this role plans, schedules, and conducts audits, oversees documentation, and supports the broader quality management program. The auditor ensures that biologics manufacturing and facility activities remain compliant with applicable regulations, policies, procedures, and phase-appropriate current Good Manufacturing Practices (cGMP), while driving quality and process improvement initiatives across the organization.

Responsibilities

• Operate within established Quality Management Systems applicable to Investigational New Drugs and Good Tissue Practices.
• Maintain up-to-date knowledge of phase-appropriate FDA and international cGMP regulations for Regenerative Medicine, Cell Therapy, and Good Tissue Practices.
• Lead data review processes to support biologic IND product release, ensuring accuracy, completeness, and compliance.
• Deliver training on GMP and Good Documentation Practices to manufacturing and support personnel.
• Lead Quality Assurance functions related to quality programs, including process audits, laboratory audits, and protocol approvals, as assigned.
• Coordinate with Biologics Manufacturing Operations and the Quality Assurance Manager to plan and conduct vendor and supplier facility audits.
• Support the Quality Assurance Manager in mentoring and training QA staff as needed.
• Support the Quality Assurance Manager during client and regulatory audits, including preparing for and participating in records reviews.
• Manage, review, and approve controlled documents, including but not limited to procedures, methods, and test protocols, to support effective biologics manufacturing and Good Tissue Practices.
• Provide additional quality assurance, auditing, and compliance support to the Quality Assurance Manager as requested.
• Collaborate closely with cross-functional teams in areas such as cell therapy, research, flow cytometry, and tissue culture to support quality objectives.
• Handle multiple tasks and priorities simultaneously in a rapidly growing department while maintaining high standards of quality and compliance.

Qualifications

• Bachelor’s or Master's degree in a scientific discipline.
• Must have Quality Assurance experience in heavily regulated environments and working with CAPAs and deviations.

Job Type & Location

This is a Permanent position based out of Columbus, OH.

Pay And Benefits

The pay range for this position is $28.00 - $30.00/hr. Individual compensation offered for this position within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, geographic location, internal equity, and other pertinent job-related factors.

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 20,000 consultants and 5,000 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. We are proud to be an Engineering News-Record (ENR) Top 500 Design Firm for our engineering design services and a ClearlyRated Best of Staffing® winner for both client and talent service.

San Francisco Fair Chance Ordinance

Pursuant to the San Francisco Fair Chance Ordinance, for all positions located in the city and county of San Francisco, we will consider for employment qualified applicants with arrest and conviction records.

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