Aktiv Pharma Group is a fast-growing company focused on addressing unmet medical needs through a proprietary drug delivery system. We are currently hiring for a Quality Assurance Specialist. This position can be held at either our Broomfield or Fort Collins facilities.

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 quality oversite of the Deviation, CAPA, Change Control and Training QMS programs at both the Fort Collins and Broomfield Aktiv locations.

At Aktiv Pharma Group, we value the diversity of perspectives and backgrounds our employees bring. We are committed to achieving a diverse workforce through application of our equal opportunity employment policy and by providing a work environment free of discrimination and harassment. We work according to our values of truth, caring, goodness and perseverance, and encourage individuals with the required skill-sets and these values to apply.

The compensation range for the Quality Assurance Specialist is $80,000 - $95,000 annually. 

Aktiv Pharma Group offers a wealth of benefits to our employees and their families.

Employee Benefits Include:

• Medical Insurance (Cigna):
  • HDHP – Aktiv contributes the full monthly premium for the employee and their dependents.
  • Two additional premium medical plan options – Aktiv contributes a portion of the monthly premium for the employee and their dependents.
• Vision Insurance (Principal/ VSP Network)
  • Aktiv contributes the full monthly premium for the employee and their dependents.
• Dental Insurance (Principal)
  • Low Plan - Aktiv contributes the full monthly premium for the employee and their dependents.
  • High Plan - Aktiv contributes a portion of the monthly premium for the employee and their dependents.
• Legal & ID Shield
  • Aktiv contributes the full monthly premium for the employee and their dependents.
• Spending Accounts (Rocky Mountain Reserve)
  • FSA
  • HSA
  • DFSA
  • LP FSA
• Ancillary Benefits (Colonial Life)
  • Accident
  • Group Medical Bridge
  • Voluntary Life AD&D
  • Disability
• 401k (Human Interest)
• Unlimited Paid Time Off
• Bi-Monthly Internet and Cell Phone stipend
• Fully Paid Membership for the employee and their dependents to Lifetime Fitness
• Fully stocked office kitchen – Health conscious and Vegan!
• Remote Work Options

Essential Duties/Responsibilities

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, specifically the Deviation, CAPA, Change Control and Training programs.
• Creates and revises documents to facilitate adherence to applicable GMP regulations.
• Quality reviewer on documentation associated with the QMS including deviation investigations, CAPA, change controls and training curriculums.
• Provides training and guidance on the Deviation, CAPA and Change Control programs.
• Tracks the associated due dates with the Deviation, CAPA and Change Control programs to ensure compliance.
• Tracks compliance with training curriculums.
• Other duties as required and necessary to ensure the success of the organization.

Job Qualifications

Competencies, Knowledge, Skills, and Abilities:

• Working knowledge and understanding of GMPs for pharmaceuticals, medical devices and/or combination products specifically in the area of deviation, CAPA, change control, and training.
• Working knowledge and understanding of GMPs for aseptic drug processing (preferred)
• 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.
• 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.

Experience:

• A minimum of 5 years of experience in a quality assurance position
• At least 2 years in management of deviations, CAPA, change control and/or training preferred
• An equivalent combination of education and experience may be substituted on a year-to-year basis.

Additional Requirements/Licenses/Certifications:

• Must have reliable transportation.
• Valid driver’s license.