American Red Cross Quality Associate II in Philadelphia, Pennsylvania
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. Qualifications:
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. 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.
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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.