Specialist QA Document Control

Profile

About Astellas Gene Therapies
Astellas Gene Therapies is an Astellas Center of Excellence 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 their 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: ****About Astellas
Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. We are promoting the Focus Area Approach that is designed to identify opportunities for the continuous creation of new drugs to address diseases with high unmet medical needs by focusing on Biology and Modality. Furthermore, we are also looking beyond our foundational Rx focus to create Rx ® healthcare solutions that combine our expertise and knowledge with cutting-edge technology in different fields of external partners. Through these efforts, Astellas stands on the forefront of healthcare change to turn innovative science into value for patients. For more information, please visit our website at ****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
Requirements
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, Care Deeply, #GetStuffDone
-- 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
Benefits:
Medical, Dental and Vision Insurance
Generous Paid Time Off options, including Vacation and Sick time, plus national holidays including year-end shut down
401(k) match and annual company contribution
Company paid life insurance
Annual Corporate Bonus and Quarterly Sales Incentive for eligible positions
Long Term Incentive Plan for eligible positions
Referral bonus program
Equal Opportunity Employer Minorities/Women/Protected Veterans/Disabled
Type
Full-time
Location
NC, Sanford
Category
Quality Assurance

Company info

Sign Up Now - WashingtondcCrossing.com