Quality Assurance and Compliance Specialist III - Laboratory

JOB SUMMARY

Assists the Vice-President, Quality and Regulatory Affairs and Director, Compliance and Regulatory Affairs with developing, implementing and executing quality assurance processes and practices that support the manufacture of FDA-regulated biologic blood, cell and tissue products and other related regulatory activities. Assists in managing and monitoring systems and processes, in support of the San Diego Blood Bank Quality and Compliance programs, promoting an organizational culture of excellence. Ensures that performance and quality of products conform to established standards and regulatory requirements. Requires the ability to analyze complex issues, work independently and the flexibility to meet changing business and stakeholder needs.

RESPONSIBILITIES

• Review, assess and monitor quality assurance programs, policies, processes, procedures and controls ensuring that performance and quality of products conform to establish standards and regulatory requirements.
• Perform regulatory review and approval of standard operating procedures, validations and other regulated documents.
• Assist in the maintenance and improvement of the San Diego Blood Bank quality and compliance programs.
• Develop and revise policies, standard operating procedures (SOPs) and other documents.
• Prepare audit tools, conduct internal audits, submit audit report and perform follow up on related corrective action plans.
• Host and/or assist departments in preparing for external inspections.
• Coordinate quality assurance and compliance-related activities with management and front-line staff.
• Assist with new/renewal applications for accreditation, licensure, certification, registration and waivers, as well as FDA license amendments.
• Assist with donor record audit reviews, including relevant investigation and resolution of errors or discrepancies.
• Initiate Quality Incident Reports after identifying errors and quarantine products as needed.
• Perform final review of Quality Incident Reports as needed.
• Assist with the investigation of Quality Incident Reports within the scope of his/her knowledge as needed.
• Review, evaluate and determine, within the scope of his/her expertise, the disposition of product.
• Determine if a recall, market withdrawal, regulatory and consignee notification is necessary due to a deviation from SOP and/or regulatory requirements.
• Review Cord Blood unit records.
• Assist with the development and implementation of performance improvement initiatives.
• Participate in corrective and preventive action teams, assist with investigation and root cause analysis and verify that actions are implemented and effective.
• Analyze data, identify trends and report findings to management.
• Participate in appropriate departmental meetings, and attend other meetings as assigned.
• Represent the San Diego Blood Bank at conferences and meetings as assigned.
• Enhance professional growth and development through participation in educational programs, current literature review, in-service meetings and workshops.
• Participate in regulatory/accrediting agency inspections.
• Educate staff on laws, regulations and standards that govern the San Diego Blood Bank.
• Ensure compliance with all applicable state and federal laws and regulations and with the standards of accrediting/certifying agencies.
• Understand and adhere to the policies and standards as developed as part of the San Diego Blood Bank Compliance Program.
• Perform other related duties as assigned or requested.

WORKING ENVIRONMENT

• Normal office environment.

PHYSICAL REQUIREMENTS

• May be subject to prolonged sitting; reaching horizontally.
• Must be able to work on a computer 4 - 8 hours a day. Must have ability to move around office and stand for prolonged periods.
• Must have ability to travel to mobile or fixed collection sites and to off-site meetings.

EQUIPMENT USED

• Normal office equipment such as computers, telephones, copy machines, fax machines and scanners.

QUALIFICATIONS

Education:

• Bachelor's degree in a work-related field/discipline from an accredited college or university. o Advanced degree preferred.

Experience:

• Must have five (5) years of progressively responsible and directly related experience. Experience should include participation in FDA and State site inspections, experience with GMP requirements, application of quality assurance principles, and healthcare compliance. Additional experience in cellular therapy services, umbilical cord banking, molecular testing and/or clinical research preferred.
• Certifications/Licenses: o ASQ, CPHQ, or Health Care Compliance Certification Board (CHC, CHRC) certification required or must be obtained within 2 years of hire. o Licensed RN or CLS preferred.

Skills:

• Knowledge of operational characteristics, services and activities of a quality program and in principles and practices used in healthcare/laboratory management, governmental compliance, internal audits, risk management, or regulatory affairs.
• Ability to approach challenges with confidence.
• Ability to perform tasks per GMP regulations including following detailed SOPs, maintaining training, deviation reporting and good documentation practices.
• Ability to perform accurate detail-oriented work.
• Ability to organize activities effectively, use effective problem-solving techniques, and make sound decisions.
• Ability to communicate effectively with internal and external customers.
• Good organizational and time management skills; must be able to establish priorities and multi-task.
• Ability to work well with others.
• Must possess good verbal and written communication skills and teaching abilities.
• Must have good knowledge of standards and regulations that apply to blood banking, umbilical cord banking, cellular therapy services, clinical laboratory, and clinical research.
• Proficient in Microsoft Suite applications (Excel, Word, PowerPoint).

The above statements are intended to describe the general nature and level of work being performed. This job description is not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified