American Red Cross Quality Assistant in Richmond, Virginia
**For VBS staff only
Reviews, assesses and monitors quality assurance programs, policies, processes, procedures and controls ensuring that performance and quality of products conform to establish standards and agency guidelines to ensure lasting customer satisfaction. Assists and/or leads operating entities in preparing for, hosting and closing out internal and external inspections/audits as necessary.
Performs quality assurance reviews, process improvement activities, participates on problem solving teams and review/approves corrective action plans and effectiveness checks. Assists and/or leads internal audits, external inspections and other assessments. May represent QA on projects, work groups or process improvement teams.
Perform all duties and responsibilities in compliance with standard operating procedures, Safety Quality Identity Potency Purity (SQUIPP), regulations outlined in the Code of Federal Regulations (CFR), Occupational Safety and Health Administration (OSHA) and other applicable Federal, state and local regulations.
Responsibilities:1. Reviews, assesses and monitors records, processes, and systems at the critical control points in the manufacturing process.2. Monitors the implementation and effectiveness of corrective actions.3. Stops the manufacture, testing and/or distribution of biomedical products or services if the process or product is compromised.4. Assists and/or leads operating entities in preparing for, hosting and closing out internal and external inspections/audits as necessary.5. Identifies manufacture, testing and/or distribution of biomedical products or services that are compromised and takes appropriate action.6. Participates in Operations and/or Quality Assurance meetings for review of quality concerns.7. Identifies and participates in process improvement and standardization activities and monitors change for effectiveness.8. May represent QA on projects, work groups or process improvement teams9. Participates in and/or leads internal quality reviews of critical areas, operations, and processes.10. Performs related duties as assigned.The above statements are intended to describe the general nature and level of work being performed. They are not intended to be an exhaustive list of all responsibilities and duties required of staff so classified. Scope:Follows established procedures for quality assurance operations, ARC directives, FDA regulations and other federal, state, and local laws.Performs job responsibilities as defined by SOPs independently and serves as resource for operational staff to advance quality improvement with minimal guidance and supervision. May assist with training QA staff.Deals with management and staff in the field, at BHQ, and outside the organization. Participates in QA activities of other operating facilities as required. Competencies:The duties and responsibilities mentioned in the job description are representative of the essential functions of the position. The performance management system incorporates competencies which are identified, discussed and evaluated in order to meet operational milestones and which are tied to job families and titles. Three types of competencies have been identified; Technical Competencies are job specific skills and methods, Core Competencies are the abilities and behaviors expected of all Biomedical Services employees, Leadership Competencies are specific abilities and behaviors required of those performing formal management roles or other leadership roles (i.e. Project Leaders). Management and staff should contact Human Resources for further details on the appropriate competencies for a specific position. Essential Functions/Physical Requirements:The duties are representative of the essential functions of the position. Physical requirements are those present in normal office environment conditions. Operational flexibility is required to meet sudden and unpredictable needs. Exposure levels are based on the essential functions as stated in this position description; however, in some instances, variances may occur due to the applicable nature of this position within a particular work site. Therefore the work site may determine the exposure level to be greater than or less than the below stated level.This position is an exposure determination 1 in view of the fact that normal work involves potential exposure to blood or blood components and/or human body fluids or tissue samples as a result of splashes, spills, and/or needlesticks or performance of or assistance in first aid.*The American Red Cross is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law. Bachelor's degree in applicable field of study or equivalent job experience. Three years experience in a GMP environment such as blood banking, pharmaceutical, medical devices or a hospital. Two years experience in QA, QC or Quality Auditing. Knowledge of federal regulatory requirements pertinent to pharmaceutical, biologic or medical device manufacturing. Good analytical and problem solving skills. Demonstrated effective verbal and written skills. Strong analytical and problem solving skills. Strong skills needed to advance compliance and quality in operations; must deal effectively with management and staff in areas, at BHQ, and outside the organization. Persuasive skill to achieve compliance with relevant procedures. Must display tact, diplomacy and professionalism in difficult situations. Must protect the confidentiality of sensitive information in the department. Must operate as a team member.
** This is a sourcing requisition that is used to identify potential candidates for several similar positions currently vacant. If you are contacted by a member of the Talent Acquisition Team, you may be directed to apply to a specific, active job opportunity. The candidate profile you build for this requisition can be used to apply for other American Red Cross opportunities.
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The American Red Cross is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law.
The American Red Cross is a diverse nonprofit organization offering its employee's professional development and growth opportunities, a competitive salary, comprehensive benefits, and a collaborative team spirit environment.