Quality And Regulatory Affairs Coordinator

Position Purpose:

Lions World Vision Institute, Inc. (LWVI) believes that all employees make a significant contribution to the companies’ success. This job description includes, however, does not limit the primary duties, qualifications, and job scope of the incumbent or LWVI. The Quality and Regulatory Affairs Coordinator (QRAC) supports the quality management system to ensure compliance with regulatory requirements including, but not limited to federal, state, local and international laws. This position will also be responsible for maintaining a high level of inventory accuracy and integrity for non-processed tissue (HCT/Ps).

Wage Range:

For the Greater Seattle Area, the range is $25.49 – 27.63.

Benefits:

• Paid time off with a starting maximum of 144.04 hours per year.
• 8 Company-paid Holidays per year.
• Include medical, dental, and vison plans for employees and their eligible dependents.
• Employer-paid Employee Assistance Program, Travel Assistance, Life, Accidental Death & Dismemberment, Short-Term Disability, and Health Reimbursement plans.
• Offerings of Supplemental Life and Accidental Death & Dismemberment for employee and their eligible dependents.
• A Regional ORCA Transit Pass for Seattle-based full-time employees.
• An employee may voluntarily designate a percentage of their salary towards employer-sponsored 401(k). LWVI will match the employee’s contribution up to 4% of the employee’s salary.
• Discounts on Pet Insurance and other items such as phone plans, movie tickets, etc.

Other Compensation

• This role is also entitled to shift differential payments.

Essential Duties and Responsibilities:

• Maintain current knowledge of FDA, relevant state, and OSHA regulations as well as AATB and EBAA standards; keep informed on industry changes, trends, and best practices.
• Assist with review and updates in the development and implementation of compliance-related policies, procedures, and forms.
• Maintain documentation of LWVI’s employee training and initial/annual competency records for all operations staff to ensure consistency as well as compliance with LWVI SOPs and Regulatory requirements.
• Perform routine internal audits of operational activities and maintain proper documentation reflecting performance against required quality standards. Investigate and analyze trends, perform root cause analysis, and ensure corrective and/or preventative measures are met.
• Execute periodic external audits of suppliers, service providers, contract laboratories, and other organizations performing a manufacturing step on behalf of LWVI.
• Perform quality control functions, including but not limited to, environmental monitoring and process validation activities.
• Initiates and completes investigations and documentation for adverse reactions, tissue recalls, withdrawals, deviations, departures, and required regulatory communication.
• Implementing occurrences with an approved corrective/preventative action plans including, but not limited to, tracking-trends, non-conformities, and tissue complaints to completion and closure while monitoring compliance systems to ensure their effectiveness.
• Aiding regulatory and accrediting agency inspections and external organization audits as needed.
• Performing all required follow-up documentation for confirmed positive infectious disease results.
• Maintaining proper equipment documentation. Including generating and reviewing IQ, OQ, PQ’s for all LWVI offices.
• Responsible for maintaining an overall knowledge of all operation processes, including referral, recovery, donor eligibility, processing, and distribution.
• Additional duties as assigned.

Education and Experience:

• Associate or Bachelor’s degree in a related field preferred.
• Minimum 1-year experience in quality or regulatory within tissue and/or eye banking preferred.
• Experience with the interpretation and practical application of FDA regulations, procedures, and guidelines that govern quality systems is preferred.
• Experience in process and equipment validation, technical writing, and organ and tissue services quality systems, is preferred.
• CEBT and/or CTBS certification preferred.

Knowledge, Skills and Abilities:

• Excellent oral / written communication and team-building skills, with the ability to collaborate effectively with all staff and contribute to a positive environment both in person and remotely.
• Ability to effectively communicate professionally as a representative of the organization with external partners, donor families, and leadership.
• Strong investigative and problem-solving skills.
• Outcome driven; can thrive in a fast-paced environment while effectively managing pressure in a professional manner.
• Ability to demonstrate adaptability and flexibility in prioritization, organizational, and multitasking skills.
• Ability to process details pertaining to death is essential.
• Ability to type >45 wpm with proficient use of basic Microsoft Office products, web browser, and a telephone system.
• Ability to work independently and as a part of a team.
• Ability to anticipate and critically think through problems.

Schedule and Travel:

The Quality and Regulatory Coordinator will periodically be required to travel by personal/company automobile, or air to meeting sites and other locations. Forty-hour work week. Must be available evenings, weekends, and holidays, when required. The coordinator will occasionally need to be in office.

Work Environment:

The work environment described here is representative of those employee encounters while performing the essential functions of the job. While performing the duties of the job, the employee is exposed to a laboratory-like environment and an office-like environment. The noise level is usually low. Open discussions about donor health and circumstances of death occur throughout the day. Equipment required for this position include but are not limited to, standard office space and equipment, standard PC equipment, printers, and telephone and/or headset.

Physical Requirements (for essential functions):

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodation may be made to enable individuals with disabilities to perform essential functions.

• Reaching. Extending hands and arms in any direction.
• Standing. Particularly for sustained periods of time.
• Fingering. Picking, pinching, typing or otherwise working primarily with fingers rather than with the whole hand.
• Grasping. Applying pressure to an object with the fingers and palm.
• Feeling. Perceiving attributes of objects, such as size, shape, temperature, or texture by touching with skin, particularly that of fingertips.
• Talking. Expressing or exchanging ideas by means of the spoken word. Those activities in which they must convey detailed or important spoken instructions to other workers accurately, loudly, or quickly.
• Seeing. Specific vision abilities required by this job include close vision and the ability to adjust focus. Far Acuity: the ability to see clearly at 20 feet or more. Near Acuity: the ability to see clearly at 20 inches or less. Depth Perception: the ability to judge distance and space relationships. Field of Vision: the ability to see peripherally. Accommodation: ability to adjust vision to bring objects into focus.
• Hearing. Perceiving the nature of sounds at normal speaking levels with or without correction. Ability to receive detailed information through oral communication, and to make the discriminations in sound.
• Repetitive motion. Substantial movements (motions) of the wrists, hands, and/or fingers.