QUALITY ASSURANCE COORDINATOR I

Company: BioLab Holdings, Inc.
Location: Mesa
Posted on: November 13, 2024

Job Description:

Description

Job Overview:

The Quality Assurance Coordinator at BioLab Sciences assumes a pivotal role in the Quality Department's daily operations, reporting to the Quality Manager/Director. This position is responsible for ensuring strict compliance with local, state, federal, AATB, and other relevant regulatory agency rules and laws.

Responsibilities:

• Thoroughly familiarize yourself with the contents of the employee handbook, fostering a comprehensive understanding of company policies.
• Demonstrate adeptness in navigating FDA Regulations pertinent to HCT/Ps, AATB regulations, and other applicable regulatory agencies.
• Collaborate with the Quality Manager/Director to conduct internal and external audits, guaranteeing adherence to prescribed regulatory agencies and accreditation prerequisites.
• Display proficiency in crafting, revising, developing, implementing, and managing Standard Operating Procedures and Policies.
• Execute comprehensive monitoring tasks within the Quality Systems, encompassing environmental, personnel, and related functions.
• Exhibit expertise in leading and performing investigations, employing established problem-solving methodologies.
• Undertake responsibility for equipment management, including procurement, utilization, scheduling validations, calibration, requalification, and routine maintenance.
• Assure the accuracy and integrity of supply records, facilities cleaning records, and training records, with a meticulous audit process to ensure error-free documentation.
• Execute meticulous Quality Review of charts to ascertain accuracy and completeness, promptly reporting any non-conformances or deviations to the Quality Manager/Director.
• Assume a safety-sensitive role, with access to sensitive donor and health information, maintaining the utmost confidentiality.
• Foster effective collaboration within a team environment, contributing positively to shared objectives.
• Excel under pressure, showcasing strong leadership skills, resilience, and self-initiative.
• Possess an in-depth understanding of regulatory agencies and their evolving requirements, demonstrating a proactive approach to compliance.
• Embody character attributes that contribute to the company's growth and success, reflecting dedication to our values.
• Exhibit adaptability in the face of change, embracing shifts with a positive attitude.
• Showcase the ability to promptly analyze issues and address them in real-time with sound judgment. Qualifications:
  • Bachelor's Degree in a Science discipline, or a demonstrated understanding of FDA requirements for biologics, HCTPs, drugs, and combinations, or USDA production environments.
  • Proficient in Universal Precautions and familiar with HIPAA regulations.
  • Minimum of 2 years of Quality Assurance experience within a tissue bank, pharmaceutical, or chemical manufacturing setting.
  • Meticulous attention to detail, coupled with exceptional organizational and communication skills.
  • Consideration given to Quality certificates in lieu of education and/or experience, with the CTBS Certificate preferred.
  • Relevant work experience in a regulated manufacturing environment, indicating a practical understanding of compliance frameworks.
  • Proficient in technical writing skills, ensuring effective documentation practices.
  • Efficient time management skills, essential for multitasking and meeting deadlines.

Keywords: BioLab Holdings, Inc., Oro Valley , QUALITY ASSURANCE COORDINATOR I, Other , Mesa, Arizona