Quality Assurance Auditor / Specialist
Actalent, Columbus, OH, United States
Job Description
We are hiring for a Quality Specialist/Auditor role here in the Columbus, Ohio area! This role will be working within compliance and integrity to support multiple different groups in gene therapy research.
An ideal candidate for this role will have a Bachelors or a Masters Degree and at least 3+ years of Quality Assurance experience, with at least a year of it being involved in investigations and deviations. Experience must come from a heavily regulated environment such as GMP, FDA, GLP, or anything similar.
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.
Minimum of 3 years of quality or regulatory experience.
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.
Benefits 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)
Workplace Type
This is a fully onsite position in Columbus,OH.
Application Deadline
This position is anticipated to close on May 8, 2026.
Diversity, Equity & Inclusion
At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I is embedded into our culture through:
Hiring diverse talent
Maintaining an inclusive environment through persistent self-reflection
Building a culture of care, engagement, and recognition with clear outcomes
Ensuring growth opportunities for our people
Actalent is an equal opportunity employer.
#J-18808-Ljbffr
We are hiring for a Quality Specialist/Auditor role here in the Columbus, Ohio area! This role will be working within compliance and integrity to support multiple different groups in gene therapy research.
An ideal candidate for this role will have a Bachelors or a Masters Degree and at least 3+ years of Quality Assurance experience, with at least a year of it being involved in investigations and deviations. Experience must come from a heavily regulated environment such as GMP, FDA, GLP, or anything similar.
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.
Minimum of 3 years of quality or regulatory experience.
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.
Benefits 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)
Workplace Type
This is a fully onsite position in Columbus,OH.
Application Deadline
This position is anticipated to close on May 8, 2026.
Diversity, Equity & Inclusion
At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I is embedded into our culture through:
Hiring diverse talent
Maintaining an inclusive environment through persistent self-reflection
Building a culture of care, engagement, and recognition with clear outcomes
Ensuring growth opportunities for our people
Actalent is an equal opportunity employer.
#J-18808-Ljbffr