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