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Aktivax, Inc, Dba Aktiv Pharma Group Quality Assurance Specialist in Broomfield, Colorado

Aktiv Pharma GroupOur CompanyAktiv Pharma Group is a Specialty Pharmaceutical company developing andcommercializing drug products in a portfolio of proprietary prefilled deliverydevices, emphasizing improved usability, safety and drug stability. Ourhighly scalable Specialty Pharma model is based on a minimal core internaldevelopment team, supported by consultants and manufacturing subcontractors.Our leading development program is an emergency auto-injector for medicalcountermeasure treatment.Our MissionWe look to develop products and treatments that improve the lives of thecommunities we serve. Our mission is to bring peace of mind to individuals andtheir communities through the work we do. Our vision is to be recognized forour innovative solutions that care for patients and communities. Our valuesare Truth, Goodness, Caring and Perseverance.Our CultureWe emphasize a safe, inviting, and inclusive culture. We are striving fora combination between a demanding and challenging work style and promoting abalanced life for our employees. We expect people to work hard, but we alsoencourage play (skiing on good snow days, meeting after work for pool,morning smoothies). We want you to bring your whole self to work. Our valuesare central to our culture and we believe that every position in this companywill help lead us to greater innovation.Job PurposeThe Quality Assurance Specialist is responsible for the implementation andmanagement of the Aktiv Quality Management System (QMS) designed forcombination (drug-device) products in compliance with standard operatingprocedures and applicable GMP regulations. This role is specificallyresponsible for supplier quality management and internal document review.Responsibilities and DutiesReasonable accommodations may be made to enable individuals with disabilitiesto perform the essential functions.* Ensures compliant implementation of the QMS as directed by planning andexecuting multiple tasks to ensure QMS is managed per procedures andapplicable GMP regulations.* Creates and revises documents to facilitate adherence to applicable GMPregulations.* Implements and maintains the supplier quality management program includingperforming supplier assessments, issuing supplier corrective actionreports, and performing periodic reviews.* Quality reviewer on documentation associated with in house manufacturingactivities including Device History Records.* Dispositions medical device subassemblies manufactured in house.* As the Subject Matter Expert for assigned responsibilities, representsquality assurance at internal meetings and site audits.* Develops and tracks goals and facilitates continuous improvements of the QMS* Provides support on various other projects as necessary, ensuringappropriate GMP compliance is maintained.* Acts as a back up to Document ControlOther duties as required and necessary to ensure the success of theorganization.Other duties as required and necessary to ensure the success of theorganization.QualificationsCompetencies, Knowledge, Skills, and Abilities:* Knowledge of and skill in using computer software and hardwareapplications, including Microsoft products (Word, Access and Excel).* Skilled in effective communication, written and verbal.* Ability to effectively present information and respond to questions frominternal customers* Skilled in multitasking while maintaining attention to detail* Must be able to use individual discretion in completing work assignments,establishing priorities, and working collectively to accomplish deadlinesand objectives.* Working knowledge and understanding of GMPs for medical devices,pharmaceuticals, and/or combination products* Ability to consistently promote, support, work, and act in a manner insupport of Aktiv Pharma Group's mission, vision and values.Ability to change direction and respond to new situations which requireimmediate attention. Education or Formal Training:* College degree (Bachelor/Associate) preferredExperience:* 3 to 5 years of e