Biologics Quality Assurance Specialist

Biologics Quality Assurance Specialist

INTERESTED CANDIDATES CAN SEND UPDATED RESUMES TO MAMCDONOUGH @ACTALENTSERVICES .COM OR TEXT MARISA . 1302 TO SET UP A PHONE INTERVIEW!

The Quality Assurance (QA) Auditor provides compliance and quality improvement support to the manufacture of phase 1/2a Investigational New Drug, Biologics manufacture, and facility operations. This role collaborates with the Quality Assurance Manager to plan, schedule, and conduct audits and administrative tasks to support the quality management program. The position ensures compliance with applicable regulations, policies, procedures, and expectations of phase-appropriate current Good Manufacturing Practices (cGMP).

The QA Auditor I will also engage in various quality improvement and process improvement initiatives.

• Operate within the Quality Management Systems applicable to Investigational New Drugs and Good Tissue Practices.
• Maintain a current knowledge of applicable phase-appropriate FDA and International cGMP regulations for Regenerative Medicine, Cell Therapy, and Good Tissue Practices.
• Lead data review processes to facilitate biologic IND product release.
• Perform GMP and Good Documentation Practices training for manufacturing and support personnel.
• Lead QA functions related to the Quality programs, such as process and laboratory audits, protocol approvals, etc., as assigned.
• Coordinate with Biologics Manufacturing Operations and QA Manager to perform vendor facility audits.
• Support the QA Manager in mentoring and training QA staff as needed.
• Assist the QA Manager during client and regulatory audits, as well as client audits for records review.
• Manage, review, and approve controlled documents necessary for the effective functioning of biologics manufacture and good tissue practices.
• Provide additional support to the Quality Assurance Manager as required.

• Bachelor's degree in a scientific discipline with a minimum of 1-2 years of quality or regulatory experience.
• Knowledge and expertise in the principles of Pharmaceutical Good Manufacturing Practices (GMP) or GLP.
• Proficiency in Microsoft Office Suite, SharePoint, and Quality Management Systems.
• Prior experience conducting audits and technical writing.
• Ability to guide and train QA staff in various tasks.
• Ability to travel for vendor/supplier audits and trainings (approximately 15%).
• Strong interpersonal, organizational, and leadership skills.
• Capability to handle multiple tasks simultaneously in a growing department.

• Experience with cell therapy, research, flow cytometry, and tissue culture.

The work environment is team-oriented, consisting of a diverse group of individuals. The current team is around four people but collaborates with several other teams, totaling approximately 23 people, with plans to expand by the end of the year. The role requires strong teamwork skills, as no work or testing is conducted in isolation. The position operates on a first shift schedule from Monday to Friday, 8:00 AM to 4:30 PM, with occasional overtime

This is a Contract to Hire position based out of Columbus, OH.

The pay range for this position is $28.00 - $28.00/hr.

Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following:

• Medical, dental & vision
• Critical Illness, Accident, and Hospital
• 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available
• Life Insurance (Voluntary Life & AD&D for the employee and dependents)
• Short and long-term disability
• Health Spending Account (HSA)
• Transportation benefits
• Employee Assistance Program
• Time Off/Leave (PTO, Vacation or Sick Leave)

This is a fully onsite position in Columbus, OH.

This position is anticipated to close on Feb 27, 2026.

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 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing due to a disability, please email actalentaccom for other accommodation options.