Quality Assurance Coordinator

The Quality Assurance Coordinator I supports daily Quality Department operations and helps maintain compliance in a highly regulated laboratory and production environment. This temporary role, offered as a 3‑month contract with potential for extension or conversion, focuses on product handling, documentation control, and quality system activities that ensure product traceability, regulatory compliance, and operational efficiency. The position provides hands-on experience with quality systems, exposure to FDA and AATB requirements, and the opportunity to contribute directly to healthcare compliance.

Responsibilities

• Support the daily operations of the Quality Department in a regulated laboratory and production environment.
• Become familiar with and adhere to company policies, procedures, and the employee handbook.
• Maintain a working knowledge of applicable FDA regulations related to HCT/Ps, AATB standards, and other relevant regulatory requirements.
• Assist with internal and external audits by preparing documentation, verifying compliance, and supporting follow-up activities.
• Draft, revise, implement, and maintain Standard Operating Procedures (SOPs) and company policies under guidance.
• Conduct monitoring activities within the Quality Management System, including environmental monitoring and personnel monitoring functions.
• Assist with investigations and root cause analysis for deviations, non-conformances, and quality events.
• Review and maintain supply records, facility cleaning records, and training documentation to ensure accuracy, completeness, and compliance.
• Perform detailed quality reviews of records and documentation to verify adherence to procedures and identify discrepancies.
• Report deviations, documentation errors, and non-conformances promptly to Quality leadership.
• Handle sensitive donor and health information with strict confidentiality and in full compliance with HIPAA requirements.
• Perform repetitive, detail-oriented tasks for extended periods while maintaining a high level of accuracy.
• Navigate and use ERP systems (such as BC or similar), MasterControl, and Excel to manage and track quality data and documentation.
• Collaborate effectively within a professional, team-oriented environment to support departmental and organizational goals.
• Maintain awareness of evolving regulatory requirements and support initiatives to enhance regulatory compliance.
• Adapt to process changes and evolving quality system requirements in a dynamic, regulated setting.
• Demonstrate strong organizational, analytical, and problem-solving skills in day-to-day quality activities.
• Contribute to donor chart reviews and tissue banking documentation as required.
• Perform other quality-related duties as assigned to support overall compliance and operational efficiency.

• At least 1 year of experience in tissue banking and donor chart review.
• 1–2 years of Quality Assurance experience in a regulated environment such as tissue banking, pharmaceutical manufacturing, medical devices, or chemical manufacturing preferred.
• Experience working within FDA-regulated environments or similar regulatory frameworks preferred.
• Knowledge of FDA regulations, HCT/P requirements, and AATB standards preferred.
• Understanding of Universal Precautions and HIPAA requirements.
• Ability to perform repetitive, detail-oriented tasks for up to 8 hours per day while maintaining accuracy.
• Strong attention to detail and accuracy in reviewing labels, forms, and components.
• Proficiency with ERP systems (BC or similar), MasterControl, and Excel.
• Strong organizational, analytical, and problem-solving skills.
• Effective written and verbal communication skills.
• Ability to work positively and collaboratively in a team environment.
• Demonstrated compliance mindset and commitment to following procedures in a regulated setting.

• Bachelor’s degree in a science-related discipline preferred, or an equivalent combination of education, training, and experience in regulated manufacturing or biologics environments.
• Previous quality assurance, quality control, or compliance experience in a regulated environment preferred.
• Technical writing and documentation experience preferred.
• Familiarity with quality platforms and electronic quality management systems.
• Experience with tissue banking, donor chart reviews, and related documentation processes.
• Previous laboratory or lab technician experience preferred.
• Familiarity with ERP systems beyond BC is a plus.
• Knowledge of quality system monitoring, including environmental and personnel monitoring activities.
• Ability to adapt to process changes and evolving quality system requirements.
• Professional demeanor and ability to work effectively in a structured, process-driven environment.
• Experience in quality, compliance, or other regulated environments for 1–2 years preferred.

This is an on-site role in a clean, regulated laboratory and production environment with a strong emphasis on professionalism, accuracy, and compliance. The standard schedule is Monday through Friday, 8:00 a.m. to 4:30 p.m. The position is offered as a minimum 3‑month contract with the possibility of extension or conversion to a lab production role upon successful completion of the project and business needs. You will work in a collaborative team setting that uses ERP systems (such as BC or similar), MasterControl, Excel, and other quality platforms to manage documentation and quality processes. The environment supports focused, detail-oriented work, frequent interaction with quality and laboratory staff, and consistent adherence to established procedures and regulatory standards.

Job Type & Location

This is a Contract position based out of Mesa, AZ.

The pay range for this position is $22.00 - $26.00/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 Mesa,AZ.

This position is anticipated to close on Apr 30, 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 : $22 - $26