Quality Assurance Coordinator I

Description

Job Title

Quality Assurance Coordinator I

Department

Compliance & Quality Assurance

Reports To

Quality Systems & Operations Manager

Location

On-Site - Mesa, AZ

FLSA Classification

Non-Exempt

Salary Range

22.26 - 30.24

Company Summary

BioLab Holdings is a biotechnology company committed to raising the standard of caring by developing, manufacturing, and commercializing breakthrough products with patient care in mind. At the heart of our work is a mission to optimize the standard of wound care through innovations grounded in science, compassion, and collaboration. We support healthcare distributors, providers, and patients worldwide who share our same initiatives to deliver clinical performance and real-world impact.

Position Summary

The Quality Assurance Coordinator I supports the daily operations of the Quality Department and assists in maintaining compliance with applicable regulatory requirements. This role helps ensure adherence to local, state, and federal regulations as well as applicable industry standards, including FDA and AATB requirements. The position contributes to quality system monitoring, documentation review, audit support, and regulatory compliance activities.

Essential Functions

• Become familiar with and adhere to company policies, procedures, and the employee handbook.

• Maintain working knowledge of applicable FDA regulations related to HCT/Ps, AATB standards, and other relevant regulatory agencies.

• Support internal and external audits by assisting with documentation preparation, compliance verification, and follow-up activities.

• Assist in drafting, revising, implementing, and maintaining Standard Operating Procedures (SOPs) and company policies.

• Conduct monitoring activities within the Quality Management System, including environmental and personnel monitoring functions.

• Assist with investigations and root cause analysis related to deviations, non-conformances, and quality events.

• Review and maintain supply records, facility cleaning records, and training documentation to ensure accuracy and completeness.

• Perform quality reviews of records and documentation to verify compliance and identify potential discrepancies.

• Report deviations, documentation errors, and non-conformances to Quality leadership.

• Handle sensitive donor and health information while maintaining strict confidentiality and compliance with HIPAA requirements.

• Collaborate effectively within a team environment to support departmental and organizational objectives.

• Demonstrate strong organizational, analytical, and problem-solving skills.

• Maintain awareness of evolving regulatory requirements and support compliance initiatives.

• Adapt to process changes and evolving quality system requirements.

• Perform other duties as assigned.

Minimum Qualifications

Education:

Bachelor's degree in a science-related discipline preferred, or equivalent combination of education, training, and experience demonstrating knowledge of regulated manufacturing or biologics environments.

Experience:

• 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, Skills, and Abilities

• Knowledge of FDA regulations, HCT/P requirements, and AATB standards preferred

• Understanding of Universal Precautions and HIPAA requirements

• Strong attention to detail and organizational skills

• Effective written and verbal communication skills

• Technical writing and documentation experience preferred

• Ability to manage multiple priorities and meet deadlines in a fast-paced environment

• Quality certifications (such as CTBS) may be considered in lieu of certain education or experience requirements

Physical Requirements

While performing the essential functions of this position, the employee may be required to remain in a stationary position for extended periods of time while working at a desk or workstation. The role requires regular use of a computer and standard office equipment such as keyboards, calculators, and printers.

The employee may occasionally be required to move or handle office materials such as files, documents, and binders weighing up to 25 pounds. The position also requires the ability to review documents, data, and information presented in electronic or printed formats.

Reasonable accommodations may be made to enable qualified individuals with disabilities to perform the essential functions of the position.

Work Environment

Work is performed in climate-controlled indoor environments that include office workspaces as well as laboratory and warehouse-style processing areas. The role requires movement throughout the facility and may involve periods of sitting, standing, and walking while performing job duties. Employees may work around laboratory or production equipment and may encounter biological materials, chemicals, and other regulated substances associated with laboratory and manufacturing operations. Personal protective equipment (PPE), such as slip-resistant footwear, disposable gloves, safety glasses, or masks, may be required depending on the work area and task being performed. Employees are expected to follow established safety procedures and maintain compliance with applicable workplace safety and regulatory requirements.

Travel Requirements

No Travel Required

What we offer: Looking for a company to work for can be a daunting task, but we believe that we stand out from the rest. Our company offers a positive and inclusive work environment, opportunities for growth and development, and a commitment to work-life balance. Join us and become part of a team that values your contributions and invests in your success.

Employment Statement

The Company is an equal opportunity employer and complies with all applicable federal, state, and local employment laws. Employment decisions are made without regard to race, color, religion, sex, national origin, age, disability, genetic information, veteran status, sexual orientation, gender identity, or any other status protected by applicable federal, state, or local law.

In accordance with the Americans with Disabilities Act, reasonable accommodations may be made to enable qualified individuals with disabilities to perform essential job functions or participate in the application process. Applicants needing accommodation should contact Human Resources.

Applicants must be legally authorized to work in the United States at the time of hire. The Company participates in employment eligibility verification as required by law.

The salary range for this position represents the anticipated compensation at the time of posting and may vary based on experience, qualifications, and geographic location where applicable.

Employment with the Company is at-will, meaning that either the employee or the Company may terminate employment at any time, with or without cause or notice, subject to applicable law.