Quality Assurance Coordinator

Job Title:

Quality Assurance Coordinator I (Contract)

Job Description

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), Master Control, 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.

Essential Skills

+ 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), Master Control, 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.

Additional

Skills & Qualifications

+ 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.

Work…