AKESOgen, Inc. is growing! Our company is seeking to hire a Quality Coordinator. The Quality Coordinator assists the Quality Manager with quality and compliance in the company. This person ensures adherence to regulatory requirements and company policies and procedures. Additionally, they safeguard the interests of the company, customers and all staff. This person ensures that assigned staff are trained and competent to perform their duties.
Description and Duties:
- Assist with the implementation of written policies and procedures and standards of conduct to promote commitment to compliance and quality
- Assist with the organization Quality Management Program
- Assist with the development of regular effective training and education for all staff
- Maintain open lines of communication and provide a process for receiving complaints without fear of retaliation or retribution
- Conduct internal auditing and monitoring to monitor compliance and reduce opportunity for error
- Investigate and remediate identified areas of nonconformance with the guidance of the quality manager
- Implement continuous improvement initiatives based on current and upcoming regulatory compliance requirements.
- Supports management team in the development of quarterly and annual performance improvement metrics and summaries for distribution to various groups within the organization.
- Responsible for the timely completion of corrective action plans.
- Participate in internal/external audits as needed
Responsibilities include but are not limited to:
- Centrifuge tachometer checks
- Thermometer calibrations/verification
- Daily tutela monitoring and follow up with leads/sups
- Fridge and Freezer qualifications
- Room maintenance daily/weekly review
- Gather all room maintenance for monthly sign off and file
- Instrument maintenance and book checks – keep up with Preventative Maintenance schedule
- Thermocycler verification
- Heat block verification
- CAPAS and Root cause Analysis, investigations
- CAPA effectiveness checks
- Daily environment rounding
- Assistance with audit responses
- State/CLIA/CAP Licensure renewals
- Training plans – keeping up to date on check offs, scheduling, completions
- Competency – keeping up to date and monitoring completions
- Media lab – monitor training and doc control for sign offs
- CAP and NYS readiness preparation of checklists
- Assist with external audits and inspections
- Assist with performing and write ups of internal audits
- BS degree in a health-related discipline with experience in quality assurance, regulatory affairs, auditing, clinical research, GCP and/or CLIA/CAP.
- Minimum 5 years of relevant experience in the disciplines noted above
- Ability to communicate effectively with all levels in the organization and with internal and external customers
- Excellent communications skills both verbal and written
- Proficient in internet and computer skills as required for the position
- Adherence to standard universal precautions
- Exposure to biological and chemical hazards