15 days old

Quality Assurance Specialist

Aktiv Pharma Group
Broomfield, CO 80021
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  • Job Code
    123434556
Aktiv Pharma Group

Our Company

Aktiv Pharma Group is a Specialty Pharmaceutical company developing and commercializing drug products in a portfolio of proprietary prefilled delivery devices, emphasizing improved usability, safety and drug stability. Our highly scalable Specialty Pharma model is based on a minimal core internal development team, supported by consultants and manufacturing subcontractors. Our leading development program is an emergency auto-injector for medical countermeasure treatment.

Our Mission

We look to develop products and treatments that improve the lives of the communities we serve. Our mission is to bring peace of mind to individuals and their communities through the work we do. Our vision is to be recognized for our innovative solutions that care for patients and communities. Our values are Truth, Goodness, Caring and Perseverance.

Our Culture

We emphasize a safe, inviting, and inclusive culture. We are striving for a combination between a demanding and challenging work style and promoting a balanced life for our employees. We expect people to work hard, but we also encourage play (skiing on good snow days, meeting after work for pool, morning smoothies). We want you to bring your whole self to work. Our values are central to our culture and we believe that every position in this company will help lead us to greater innovation.

Job Purpose

The Quality Assurance Specialist is responsible for the implementation and management of the Aktiv Quality Management System (QMS) designed for combination (drug-device) products in compliance with standard operating procedures and applicable GMP regulations. This role is specifically responsible for supplier quality management and internal document review.

Responsibilities and Duties

Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

  • Ensures compliant implementation of the QMS as directed by planning and executing multiple tasks to ensure QMS is managed per procedures and applicable GMP regulations.
  • Creates and revises documents to facilitate adherence to applicable GMP regulations.
  • Implements and maintains the supplier quality management program including performing supplier assessments, issuing supplier corrective action reports, and performing periodic reviews.
  • Quality reviewer on documentation associated with in house manufacturing activities including Device History Records.
  • Dispositions medical device subassemblies manufactured in house.
  • As the Subject Matter Expert for assigned responsibilities, represents quality 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, ensuring appropriate GMP compliance is maintained.
  • Acts as a back up to Document Control

Other duties as required and necessary to ensure the success of the organization.

Other duties as required and necessary to ensure the success of the organization.

Qualifications

Competencies, Knowledge, Skills, and Abilities:

  • Knowledge of and skill in using computer software and hardware applications, including Microsoft products (Word, Access and Excel).
  • Skilled in effective communication, written and verbal.
  • Ability to effectively present information and respond to questions from internal 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 deadlines and 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 in support of Aktiv Pharma Group's mission, vision and values.

Ability to change direction and respond to new situations which require immediate attention. Education or Formal Training:

  • College degree (Bachelor/Associate) preferred

Experience:

  • 3 to 5 years of experience in a quality assurance position
  • An equivalent combination of education and experience may be substituted on a year to year basis.

Additional Requirements/Licenses/Certifications:

  • Reliable transportation required.
  • Valid driver's license required.

Aktiv Pharma Group is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity or national origin.



PI123434556
Posted: 2020-09-09 Expires: 2020-10-11

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Quality Assurance Specialist

Aktiv Pharma Group
Broomfield, CO 80021

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