Document Control Supervisor

5 days ago

Fishers, United States INCOG BioPharma Services Full time

Document Control Supervisor


INCOG Biopharma Services in Indianapolis, IN is hiring a Document Control Supervisor. INCOG is seeking a Supervisor that will be instrumental in developing and championing INCOG’s approach to the design, approachability, control, and training of content; ultimately being a major contributor for the Integrity of the management of data/information at the site. The Supervisor will manage the team responsible for the flow of documents, records, and subject matter experts, and own the logistical operations for all site inspections.


The primary function of this role will be to manage the Document Control team, and be responsible for the flow of documents, records, and subject matter experts, and own the logistical operations for all site inspections.


There is a growing need globally for more CDMOs (contract development and manufacturing organization) in the pharmaceutical industry to provide comprehensive services from drug development through drug manufacturing.


At INCOG, there are more than just a CDMO. A better way to create more meaningful experiences. A better way to create a culture that everyone can thrive and succeed in. At their core, that is who they are—a dedicated team that believes they can always be better.


Join the team at INCOG, a world-class CDMO for parenteral injectable drugs, shaping a new future for patients, for yourself, and for INCOG’s clients.


Job Functions:


  • Administrate the routing, review, release, and retirement of controlled documents in an electronic document management system (including Batch Records, Logbooks, QC Methods, etc), as well as the eLearning system.
  • Design the training and train new employees on the requirements and significance of Good Documentation Practices, controlled document management, and GxP training.
  • Lead behind-the-scenes activities for client and health authority inspections, including maintaining documents, records, and other logistics in a state of continual inspection readiness.
  • Administrate the Periodic Review of controlled documents program, and the annual logbook and curricula review cycles, and maintain the site licensure documentation and coordinate renewal routing.
  • Organize and lead the Document Control Technicians in their support of all applicable programs, provide them mentorship, and design and support their annual and career development goals.
  • Manage the processes for the repository and routing client-related controlled documents and the provision and of client-related records.
  • Provide technical writing and information design support in document authoring and document hierarchy decision-making, as well as technical support and tips and tricks to internal customers for Microsoft Word and Excel.


Candidate Requirements:


  • Bachelor’s degree in a scientific or language/communications field
  • At least 2 years’ experience in a regulated industry, including 1 year within the Pharmaceutical industry.
  • 1+ years’ experience as an Administrator of an electronic document management system, records management, i.e. issuance and reconciliation processes and storage controls.
  • At least 3 years’ experience designing, writing, and/or editing documents of a technical nature, and providing internal customer service, support/troubleshooting and/or training/presenting publicly.
  • Certification in Technical Writing or Information Management.


Why INCOG?


  • Paid time off, based on tenure
  • 11 paid holidays
  • 401(k) plan with company match up, vested immediately
  • Choice of health & wellness plans
  • FSA and HSA options
  • Onsite wellness facility
  • Employee engagement activities; food trucks, monthly luncheons, fundraising events, team building competitions, offsite celebrations


Don’t meet all the requirements? Don’t sweat We’re always looking for an excuse to discuss your next opportunity. You might just surprise yourself…


Lead Candidate wholeheartedly supports Equality and Diversity in employment and opposes all forms of unlawful or unfair discrimination on the grounds of age, disability, sex, gender reassignment, sexual orientation, pregnancy and maternity, race, religion or belief and marriage and civil partnerships.

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