American Red Cross Quality Assurance Officer in St Paul, Minnesota
We are currently seeking aQuality Assurance Officer in St. Paul, MN!
Works as a senior quality employee dedicated to a specific facility/function to ensure that manufacturing processes and products are consistently high in quality and meet regulatory requirements. Primary focus is quality/regulatory technical support for a specific facility/function. Quality Assurance (QA) representative that is integrated into the operations facility/function to provide support, guidance and oversight to the operations function they are dedicated to support. Works collaboratively with other departments to achieve quality objectives and business results.
- Responsible for problem solving, compilation of quality metrics and communication of compliance status to management and staff for facility/function.2. May prepare for, host and close out internal and external inspections/audits and participate in the response to audit observations.3. Represents QA and/or leads projects, work groups or multi-functional process improvement, change control, consolidation and standardization teams.4. Works collaboratively with operations and Problem Management in problem solving activities or functions.5. Evaluates operational processes and proposes quality improvements. 6. Stop the manufacture and/or distribution of biomedical products/services should it be determined that the safety, purity, quality and/or potency of the product or process has been compromised.7. Perform 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.
Bachelor's degree in applicable field of study or equivalent related experience. Seven years of experience in a GMP environment such as blood, plasma, tissue, drug or medical device firm; to include four years functional experience in QA, QC or QA Auditing, plus minimum of one recognized accreditation in a Quality related field. Demonstrated superior verbal and written skills. Knowledge of operations in a biologics, pharmaceutical or medical device manufacturing environment. Knowledge of federal regulatory requirements and quality assurance practices/principles related to medical industry manufacturing operations. Courses and practical experiences in leadership role. Must display tact, diplomatic and professionalism in difficult situations. Must protect the confidentiality of sensitive information in the department. Must operate as a team member.
Apply now! Joining our team will provide you with the opportunity to make a difference every day.
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.