QUALITY ASSURANCE COORDINATOR I
Company: BioLab Holdings, Inc.
Location: Mesa
Posted on: October 29, 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., Gilbert , QUALITY ASSURANCE COORDINATOR I, Other , Mesa, Arizona
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