Director of Quality Assurance

HOUCHIN COMMUNITY BLOOD BANK•Bakersfield, CA

10d

About The Position

PURPOSE OF POSITION: The Director of Quality Assurance (QA) is responsible for ensuring all areas of the blood center are operating in compliance with applicable government regulations, accrediting agency standards or consignee requirements related to the collection, processing, testing and distribution of blood products and services. The QA Director participates as a member of the management team in planning, program formulation, and systems development. The QA Director is responsible for designing, implementing, and monitoring the quality assurance program for all operating levels of the blood center.

Requirements

Extensive experience in a regulatory environment with 5+ years in a management position in quality/compliance/regulatory audit preferable in laboratory, blood services, cell therapy or healthcare industry.
Bachelor’s Degree in life sciences area
Detailed understanding of blood bank operations and quality assurance requirements. (AABB, cGMP, CLIA and CFR)
Strong technical writing, verbal communication, and presentation skills
High attention to detail, strong documentation practices, and sound data integrity/GDP principles
Working knowledge of Quality Management Systems and regulated laboratory operations, with documented experience in: SOP lifecycle management Equipment qualification and validation Deviation investigation and CAPA Personnel training and competency assessment Database management
Ability to closely follow quality standards
Analytical and decision-making skills
Ability to lift, carry, push, and pull up to 45 pounds
Work in air-conditioned building
Frequent use of computer, mouse and terminal with sitting and/or sitting continuously throughout the day
Occasional standing and may bend for periods of time

Nice To Haves

Certified Quality Auditor (ASQ CQA), desired
Specialist in Blood Banking (SBB), desired

Responsibilities

Establish and maintain aggressive compliance program that meets federal regulations, industry standards and consignee or customer requirements.
Oversee planning and implementation of quality assurance and operation projects.
Review current and new regulations, standards or proposed changes with regard for potential impact on operations or standard operating procedures.
Review new and revised standard operating procedures and validations for compliance with appropriate regulations and standards.
Lead and coordinate regulatory, accreditation and consignee inspections. Coordinate response with appropriate department managers.
Oversee, prepare and review correspondence related to FDA licensure and licensure applications.
Lead and oversee internal audit process to maintain continuous inspection readiness across processing, equipment, documentation, and personnel competency systems. Audits may include site/mobile locations, processes, documentation, and supplier or service provider audits.
Establish and oversee training, qualification, and competency programs, including job descriptions, personnel qualification criteria, competency assessment programs, training records, and continuing education requirements, to ensure compliance with regulations and standards. Actively educate staff on cGMPs, regulations, standards, procedures and processes.
Establish and maintain oversight of system for prevention, detection, investigation, tracking and corrective action of errors. Perform appropriate notification (e.g. FDA BPDRs or customer notifications) as appropriate. Oversee investigations including: Deviation Events, Correction Reports, BPDRs, etc.
Oversee document control process and procedures. Work with the department designees to ensure planning, implementation, tracking and review of all related documents follows appropriate policies and procedures.
Oversee documentation of manufacturing equipment for installation activities and after repair qualification activities following FDA and AABB requirements.
Perform annual facility submission to the FDA (e.g. Annual report and registration)
Maintain authority to approve or reject blood components, supplies and production records.
Perform duties and promote compliance with all applicable regulatory and accrediting agencies. Ensure OSHA regulations and cGMP are adhered to. Work with all departments to ensure that standard operating procedures are followed, ensuring the safety of blood and products are compliant with FDA and AABB requirements. Provide QA/compliance review of forms and documents as needed.
Oversee Quality Assurance Committee and create management updates.
Maintain a record retention schedule according to FDA and AABB requirements. Maintain an adequate organizational structure to ensure manufacturing is in accordance with FDA and AABB requirements.
Assist management team in reviewing processes and recommending changes to improve quality. Assist with the review of product quality, monthly quality control testing, and proficiency testing results and reporting.
Understands and adheres to the policies and standards as developed by Houchin Community Blood Bank. Participates in appropriate departmental and organizational meetings as assigned.