QA Specialist, Document Control at Astellas Gene Therapies (Orlando, FL)

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Why Work for Us

Are you ready to use your experience and expertise to make an impact on patients’ lives? Astellas Gene Therapies is a biotechnology company developing new genetic medicines for rare, life-threatening diseases. We are working urgently to progress our medicines and need additional team members to help us do so. Because our mission is so important, our values are to: Be BOLD: Find a Way, Care Deeply, and Get Stuff Done. If you’d like to be a part of this important mission, please apply to join our team.

About Astellas Gene Therapies

Astellas Gene Therapies is developing genetic medicines for patients with rare, life-threatening diseases. Based on our innovative approach to developing genetic medicines, as well as our industry-leading internal manufacturing capability and expertise, we have become the Astellas Center of Excellence for the newly created Genetic Regulation Focus Area. We are currently exploring three gene therapy modalities: gene replacement, exon skipping gene therapy, and vectorized RNA knockdown, with plans to expand our focus and geographic reach under Astellas. We are based in San Francisco, with manufacturing and laboratory facilities in South San Francisco and Sanford, North Carolina. For more information, please visit our website: www.audentestx.com.

Our Values:

  • Be BOLD (Find a Way)
  • Care Deeply – for our patients, each other and our work
  • #GSD (Get Stuff Done)

What is the catalyst for you in your professional career? Are you ready to be a part of a bold, innovative company, to make a change and to make a difference? Listed below is a current opening for a smart, driven, experienced, and just plain nice individual who wants to join us and be a part of our journey.

The Role

Reporting to the Senior Manager, QA Document Control & Training, the Specialist, Document Control has responsibilities the technical and administrative support of the GxP regulated functional departments and their clients. Activities will include, but are not limited to, management of the Electronic Document Management System (EDMS) and its contents, word processing and formatting of documents, maintaining GxP records in the QA archive, and providing end user customer support. Participates in independent and team projects as defined by the department manager. This position will be located in Sanford, NC.

Primary Responsibilities

  • Implementation, maintenance and continuous improvement of the document management system and other processes associated with control of documents and records
  • Execute strategic initiatives to improve controlled document management and issuance processes, governance procedures and electronic systems
  • Collaborate with cross-functional departments to ensure timely implementation of document change requests and change control associated tasks.
  • Facilitate the life cycle of master documents (including but not limited to SOPs, Batch Records, Test Methods, Protocols, Reports, Specifications, etc.) by functioning as a document workflow coordinator
  • Review, edit, format master documents according to approved procedures and templates, maintains document properties (metadata), monitor document status and approval notifications, distributions and archiving
  • Collaborate with cross-functional departments to ensure timely implementation of document change requests and change control associated tasks
  • Issue effective documents including logbooks, procedures, test methods, specifications, batch documentation and labels and maintain issuance logs
  • May coordinate and perform routine audits of documents maintained to ensure that all documents are accounted for and current
  • Execute duties associated with controlled document change requests (i.e. document formatting, approvals, effectiveness, and distribution)
  • Assist with end-user training for new users and provide on-going user support for electronic document management system
  • Provides day-to-day operation support for departments (e.g. scheduling, reporting, records archiving)
  • Manage storage database run reports for retention and metrics
  • Assist with metric generation and reporting for Quality management
  • Conducts quality assurance tests to ensure images meet quality standards; appends or correct images in response to quality assurance findings
  • Coordinates with Training personnel to ensure training materials and files are appropriately stored in electronic document management system and archived as necessary
  • Supports internal and external audits and may support delivery of document control system overview to board of health inspectors during regulatory inspections
  • May also support the preparation and hosting of internal audits and regulatory (e.g. FDA, EMA, DHHS, etc.) inspections

About you

Must Have/Required

  • S. degree and 8+ years of experience or M.S. degree and 6+ years of experience in a related function, preferably in a biologics manufacturing facility
  • Possess strong computer and Internet skills, including online document management experience and proficiency in Microsoft Office (Outlook, Excel, Word, & PowerPoint)
  • Experience with Electronic Document Management Systems
  • Excellent oral and written communication skills
  • Demonstrated knowledge of cGMPs
  • Exhibits a good understanding of general quality assurance concepts and practices
  • Highly organized with a strong attention to detail
  • Successful history of solving problems of moderate complexity
  • Proven ability to manage both day-to-day operations, as well as project work in a fast-paced environment
  • Familiar with project management methodology and process
  • Models our Core Values: Be Bold: Find a Way, Care Deeply, Get Stuff Done – is experienced as someone who exemplifies the culture we want to create; operates with transparency; is trusted

May Have/Preferred

  • Experience in a small company and high growth, fast-paced environment
  • Experience with Veeva Vault, MasterControl and implementation of an EDMS
  • Familiar with applicable US and international regulatory requirements (e.g. 21 CFR Parts 11, 210, 211, 820)
  • Experience supporting regulatory inspections

All qualified applicants will receive consideration for employment without regard to race, sex, color, religion, sexual orientation, gender identity, national origin, protected veteran status, or on the basis of disability.

More Information on Astellas Gene Therapies
Astellas Gene Therapies operates in the Biotech industry. The company is located in San Francisco, CA. Astellas Gene Therapies was founded in 2012. It has 395 total employees. To see all jobs at Astellas Gene Therapies, click here.
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