What are the responsibilities and job description for the Biologics Quality Assurance Manager position at Actalent?
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Description
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 will work in conjunction with the Quality Assurance Manager to plan, schedule and conduct audits and administrative tasks to support the quality management program. In addition to conducting activities that ensure the biologics manufacture and facility is compliant with applicable regulations, policies, procedures and expectations of phase appropriate current Good Manufacturing Practices (cGMP). The QA Auditor I will perform a variety of quality improvement and process improvement initiatives as requested by the Quality Assurance Manager.
1. Operate within the Quality Management Systems applicable to Investigational New Drugs, and Good Tissue Practices.
2. Maintain a current knowledge of applicable phase appropriate FDA and International cGMP regulations for Regenerative Medicine, Cell Therapy, and Good Tissue Practices.
3. Lead data review processes to facilitate biologic IND product release.
4. Perform GMP and Good Documentation Practices training for manufacturing and support personnel.
5. Ability to lead QA functions related to the Quality programs such as process, laboratory audits, protocol approvals, etc. as assigned.
6. Coordinate with Biologics Manufacturing Operations and QA Manager to perform vendor facility audits.
7. Support the QA Manager in mentoring and training QA staff as needed.
8. Support the QA Manager during client and regulatory audit, client audits for records review.
9. Manage, review and approve controlled documents including but not limited to SOPs, Methods, Test Protocols for the effective functioning of biologics manufacture, good tissue practices.
10. Provide additional support to the Quality Assurance Manager as required.
Skills
biology, Quality assurance, Auditing, Compliance, gmp, cell therapy
Top Skills Details
biology,Quality assurance,Auditing,Compliance,gmp,cell therapy
Additional Skills & Qualifications
MUST HAVE:
1. Bachelor’s degree in scientific discipline with a minimum of 1-2 years quality or regulatory experience.
2. Knowledge and expertise in the principles of Pharmaceutical Good Manufacturing Practices (GMP) or GLP
3. Excellent computer skills required: Microsoft Office Suite, SharePoint, Quality Management Systems.
4. Prior experience conducting audits, technical writing, SOP writing preferred
5. Ability to guide and train QA staff in various tasks.
6. Ability to travel for vendor/supplier audits and trainings (approx. 15%).
7. Strong interpersonal, organizational, leadership
8. Must be able to handle multiple tasks simultaneously in a growing department.
9. Strong computer skills
Experience Level
Expert Level
Job Type & LocationThis is a Contract to Hire position based out of Columbus, OH.
Pay and BenefitsThe 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)
Workplace TypeThis is a fully onsite position in Columbus,OH.
Application DeadlineThis position is anticipated to close on Mar 31, 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.
About Actalent
Actalent is a global leader in engineering and sciences services. For more than 40 years, we’ve helped visionary companies advance their goals. Headquartered in the United States, our teams span 150 offices across North America, EMEA, and APAC—with four delivery centers in India led by 1,000 extraordinary employees who connect their passion with purpose every day.
Our Bangalore, Hyderabad, Pune, and Chennai delivery centers are hubs of engineering expertise, with core capabilities in mechanical and electrical engineering, systems and software, and manufacturing engineering. Our teams deliver work across multiple industries including transportation, consumer and industrial products, and life sciences. We serve more than 4,500 clients, including many Fortune 500 brands. Learn more about how we can work together at actalentservices.com.
Salary : $28