Job DescriptionThe Quality and Regulatory Services Coordinator / Safety Officer will perform the quality and regulatory affairs and safety duties and responsibilities by reviewing facility and department procedures, forms, training documents, product and equipment quality control (QC), change control processes, and validations, and assist with the development, as necessary. Duties and ResponsibilitiesThe list of essential functions, as outlined herein, is intended to be representative of the duties and responsibilities performed within this classification. It is not necessarily descriptive of any one position in the class. The omission of an essential function does not preclude management from assigning duties not listed herein if such functions are a logical assignment to the position. All employees must perform all assigned duties in compliance with internal SOPs, external regulations, and internal policies, bring compliance issues to management's attention, and assure quality customer service to all customers.
- Develop, perform, and report departmental and system audits.
- Perform safety audits, drills, and inspections.
- Personnel Training: Perform Good Manufacturing Practice (cGMP), and safety training, and assist in inter-departmental training, and competency evaluation.
- Maintain compliance by enforcing applicable regulations and standards set by regulatory agencies (FDA, CLIA, AABB, OSHA) and submit appropriate reports when required.
- Maintain Employee Signature sheets, Visitor Log, and alarm system codes for facility.
- Maintain Key Control for facility.
- Document Control: Maintain proficiency in Document Control within MediaLab. Revise and create SOPs, Forms, and Job Aids. Maintain SDS. Maintain Disaster Protocol.
- Perform Equipment Management for facility equipment, including safety equipment.
- Create, perform, and review validations.
- Oversee Error Management, including documentation, recognition, trend analysis, and root cause analysis.
- Oversee Donor Reaction, Employee / Visitor Injury, and Vehicle Damage investigations, including documentation, recognition, trend analysis, and root cause analysis.
- Oversee Hepatitis B vaccination program for employees.
- Oversee Pest Control and Janitorial chemical use within the facility.
- Monitor and conduct trend analysis of Quality Indicators and Safety Data.
- Manage process improvement, including change control and corrective / preventative actions.
- Coordinate and assist in maintaining safety and risk management functions that the operational and administrative departments of the blood center perform.
- Assist in external inspections.
- Support the Director of Quality and Regulatory Services.
- Evaluation of positive test results and lookback.
- Conduct donor counseling.
- Attend Healthcare Coalition and other safety related meetings and conferences, as necessary.
- Supports the QRS Mission Statement.
- Perform all other duties as assigned.
Qualifications Education: Associate or Bachelor's degree in a related field required, Medical Technologist / Technician or Quality Assurance Technician strongly preferred Experience: A combination of one or more years of experience in blood banking / laboratory or manufacturing with solid familiarity with cGMP, safety in a manufacturing setup, and OSHA regulations. Quality Assurance and Safety Officer experience preferred.