Document Control Associate I, II, III, or Specialist I

Aktiv Pharma Group ('Aktiv') is a fast-growing, vertically integrated specialty pharmaceutical company with combination products CDMO capabilities, developing, manufacturing, and commercializing sterile-injectable products in a portfolio of proprietary, value-added, prefilled delivery systems. The company's team of 80 employees harmonize all aspects of combination product development and manufacturing with effectively synchronized operations, including chemistry, device development, manufacturing equipment development, material science, quality and regulatory, in-house cleanroom assembly operations, and in-house sterile fill-finish. Aktiv commercializes drug products independently as well as supporting other pharmaceutical companies address unmet needs and create competitive advantage in the market. Aktiv leading products are proprietary emergency medicine in autoinjectors.

Aktiv's mission is to deliver peace-of-mind to patients and their communities, and its values are truth, perseverance, caring, and goodness. The company's culture emphasizes diversity, equity, and inclusivity and implementing leadership across the entire organization. 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 believe that our DEI initiatives are an opportunity to make a difference beyond our organization, in our community and society. Aktiv is grateful to be taking part in the individual journey of its employees and is striving to support a balanced life experience. We are striving to create a safe and inviting work place in which our team would be excited to come in the door at the beginning of the work day, and leave at the end of their day with a sense of accomplishment and value.

We are currently hiring a Document Control Associate/Specialist for our Ft. Collins Facility

The Position: The Document Control Associate/Specialist is responsible for the implementation and management of controlled documents in accordance with Aktiv standard operating procedures and applicable GMP regulations.

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.

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

Employee Benefits Include:

• The compensation range for the Document Control Associate I, II, III, or Specialist I is $60,000 - $70,000 annually.
• 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!
• This position will be on location, but flexible work arrangements can be discussed.

Essential Duties/Responsibilities

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

• Maintains controlled document files (hard copy and electronic).
• Maintains a GMP-compliant document management system.
• Plans and executes multiple tasks to ensure controlled documents are managed per procedures and applicable regulations.
• Issues controlled documents in accordance with applicable procedures.
• May manage activities in the Training and Document Management System (TMS) according to procedure.
• May act as Subject Matter Expert (SME) for document control.
• May provide training to personnel on the document management system per relevant procedures.
• May represent document control at internal meetings and during audits.
• May act as administrator for electronic systems used for document management.
• Develops and tracks goals and facilitates continuous improvements of the document management system.
• Provides support on various other projects as necessary, ensuring appropriate document control is maintained.
• Collaborates and communicates cross-functionally, to support alignment of processes, systems and procedures within document control and user experience within document control.
• Ensures partnerships are built and maintained with areas that document control supports to drive high quality throughput via efficient and effective document control processes.
• Maintain relationships with internal and external departments. Communicate any resource constraints when identified.
• Other duties as required and necessary to ensure the success of the organization.

Job Qualifications

Competencies, Knowledge, Skills, and Abilities:

• Knowledge of manual and electronic document management and quality management system (s)is required (Training and Document Management System (TMS) preferred).
• Knowledge of and skill in using computers, computer software and hardware applications, including Microsoft products (Word, Access and Excel) and electronic document management systems.
• Strong and effective, written and verbal communication skills.
• Ability to effectively present information and respond to questions from internal customers.
• Skilled in maintaining attention to detail while performing multiple tasks. Ability to handle multiple responsibilities simultaneously and still meet high quality and timeliness standards under pressure.
• 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 industry GMPs for pharmaceuticals and medical devices
• Strong interpersonal, teamwork and customer interfacing skills; ability to build productive working relationships across a diverse spectrum of people.
• Self-motivated, and able to organize and prioritize multiple tasks strong organization and time management skills; Ability to change direction and respond to new situations which require immediate attention.
• Ability to consistently promote, support, work, and act in a manner in support of Aktiv Pharma Group's mission, vision, and values.
• This position is based in Ft Collins, however there is a need to maintain the ability to work between locations, as requested.

Experience and Education:

• High School diploma required
• College degree (Bachelor/Associate) or other secondary training preferred
• 1 to 4 years of experience in a Document Control or Quality position
• An equivalent combination of education and experience may be substituted on a year-to-year basis.

Additional Requirements/Licenses/Certifications:

• Must have reliable transportation. Currently have multiple locations.