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.