Document Control Specialist

Document Control Specialist

Audentes Therapeutics

Document Control Specialist

Details of the offer

Document Control Specialist
About Audentes Therapeutics
Audentes Therapeutics is a leading AAV-based genetic medicines company focused on developing and commercializing innovative products for serious rare neuromuscular diseases. We are leveraging our AAV gene therapy technology platform and proprietary manufacturing expertise to develop programs across three modalities: gene replacement, vectorized exon skipping, and vectorized RNA knockdown. Our product candidates are showing promising therapeutic profiles in clinical and preclinical studies across a range of neuromuscular diseases. Audentes is a focused, experienced and passionate team driven to improve the lives of patients.
Audentes leverages strong, global relationships with the patient, research, and medical communities, and we take pride in carefully selecting our colleagues. Listed below is a current opening for a smart, driven, experienced, and just plain nice individual who wants to join us on our journey.
The Role
Reporting to the Senior Manager, Document Control, the Document Control Specialist has responsibilities in all aspects of the support provided to the GxP regulated functional departments and their clients. Activities will include but are not limited to word processing of documents, maintaining GxP records in the QA Archive, processing records in the Electronic Document Management System(EDMS), and providing customer support. Participates in independent and team projects as defined by the department manager. This position will be located in South San Francisco.
Responsible for enhancing and maintaining the document change control system and other processes associated with document control. Execute strategic initiatives to improve the document management system.
Collaborate with cross-functional departments to ensure timely implementation of document change requests and change control associated tasks.
Issue effective documents including procedures, test methods, specifications, batch documentation and labels.
Reviews, edits, formats master documents according to approved procedures and templates, maintains document properties (metadata), monitors document status and approval notifications, distributions and archiving.
Issue batch records for manufacturing use and maintain issuance log.
Issue logbooks for GxP equipment and facilities use.
Issue lab notebooks and maintain issuance log.
Develop and implement training content for document management and issuance processes and procedures.
May coordinate and perform routine audits of documents maintained in order 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 in electronic document management system.
Provide on-going user support for the 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 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 Manager to ensure training files are appropriately stored in electronic document management system and archived as necessary.

Required Qualifications
BS degree and 8+ or Master's with 6+ years in Document Control, Quality Assurance or relevant work experience in the Biotechnology or Pharmaceutical industries or relevant, regulated environments
Demonstrated knowledge of GMP
Strong experience with Electronic Document Management Systems
Excellent oral and written communication skills
Exhibits a good understanding of general quality assurance concepts and practices
Highly organized with 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
Possess strong computer and Internet skills, including online document management experience and proficiency in Microsoft Office (Outlook, Excel, Word, & PowerPoint)
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.

Preferred Skills and Experience
Experience with Veeva Vault
Familiar with applicable US and international regulatory requirements (e.g. 21 CFR Parts 11, 210, 211, 820)

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.
(ref. 2020B-014)

Source: Jobsxl


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