This job has expired

Document Control Specialist

Employer
Spark Therapeutics
Location
Philadelphia, Pennsylvania. Hybrid and remote options available for select opportunities.
Salary
Salary not provided
Closing date
May 21, 2022

View more

Discipline
Other, Manufacturing/QA/QC
Organization Type
Pharma
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Job Details

Primary Duties:

The Quality Assurance (QA) Specialist, Document Control will work with QA Systems lead to develop and deploy the Veeva Quality Doc System, manages and tracks all GMP documentation. Following Spark SOPs, the QA Specialist is responsible for adhering to the Spark document lifecycle procedures and archives all records in accordance with the records retention schedule, as well as retrieving all documents as requested. The QA Specialist, Document Control will collaborate with the Document Control team in providing administrative support in processing different types of documents in the EDMS along with managing multiple projects within Document Control department and help support/ maintain changes to the DMS.

Responsibilities:

  • Manage and maintain controlled documents in Electronic Document Management System (EDMS) ensuring documents go through controlled documents life cycle in accordance established procedures with little or no assistance/direction
  • Independently review SOP and form content and exercise judgments to provide suggestions to author to ensure alignment with Spark controlled document procedures and best practices
  • Track controlled documents to ensure reviews and approval are completed within the EDMS
  • Manage file rooms inventory, filing, scanning and Offsite documents archival with Iron Mountain.
  • Provide site training on EDMS workflow to other departments before granting users access.
  • Coordinate the review, finalization, and archival of Spark policies, procedures and other controlled documents
  • Train and provide oversight to Document Control contractor(s) staff in processing documents in the EDMS, issuance logbooks, notebooks, and batch records.
  • Manage the Easyvista (EV) on all incidents and requests for the EDMS and close all EV’s tickets in a timely manner.
  • Serve as an Administrator of the EDMS including user account management, system configuration, troubleshooting and work with EDMS vendor.
  • Provide documentation support during an audits and regulatory inspections.
  • Edit and proofread controlled documents for consistency of document format and template requirements, and adherence to Quality Systems processes and procedures.
  • Follow GxPs and Spark SOPs and Policies
  • Implement and utilize advanced Word processing and automation features of MS Office software
  • Other assigned responsibilities as established by the QA Systems Lead

Education and Experience Requirements:

  • B.S./B.A. in biological sciences, physical sciences or equivalent experience
  • 2-5 years of experience in working with documentation in a regulated industry
  • Computer literacy required; Advanced MS Office skills (Outlook, Word, Excel, PowerPoint)

Key Skills, Abilities, and Competencies:

  • Knowledge of GxP concepts and guidelines
  • Experience with document control activities required
  • Experience with advanced Document Control system not necessary, but is a plus
  • Requires strong written, oral, interpersonal, and communication skills and English fluency
  • Effective knowledge of maintaining a document and data control system
  • Effective organization and planning skills
  • Demonstrated ability to deal with frequent changes, delays or unexpected events
  • Must be able to follow established policies and procedures, and comply with regulatory requirements related to documentation
  • Demonstrated ability to perform detail-oriented work with a high degree of accuracy and completeness
  • Must have general understanding of FDA regulatory requirements as they relate to documentation
  • Extensive MS Word processing and formatting experience required
  • Experience in automating process utilizing MS Office products.
  • Must have a strong attention to detail
  • Ability to effectively communicate and share knowledge with a team
  • Learning Management System experience, a plus

Complexity and Problem Solving:

  • This position must be able to think critically and solve documentation problems.

Internal and External Contacts:

  • This position will interact with all Internal Spark employees that use the EDMS as well as interact with external vendors that support long term storage of documents for Spark.

Other Job Requirements:

  • The position may require occasional shift work, including weekends, off hours and holidays as needed.

#LI-2326

Please be aware that Spark mandates COVID-19 vaccination of all employees regardless of work location. Accommodations may be made in accordance with applicable law.


Nearest Major Market: Philadelphia



Join the Spark Team

We were born of innovation, springing from the curiosity, imagination and dedication of remarkable scientists and healthcare visionaries. Our shared mission is to challenge the inevitability of genetic disease by discovering, developing, and delivering treatments in ways unimaginable - until now.

We don't follow footsteps. We create the path.

Company

At Spark Therapeutics, a fully integrated, commercial company committed to discovering, developing and delivering gene therapies, we challenge the inevitability of genetic diseases, including blindness, hemophilia, lysosomal storage disorders and neurodegenerative diseases.

Founded in March 2013 as a result of the technology and know-how accumulated over two decades at Children’s Hospital of Philadelphia (CHOP), our investigational therapies have the potential to provide long-lasting effects, dramatically and positively changing the lives of patients with conditions where no, or only palliative, therapies exist. Greater understanding of the human genome and genetic abnormalities have allowed our scientists to tailor investigational therapies to patients suffering from very specific genetic diseases. This approach holds great promise in developing effective treatments to a host of inherited diseases. Our initial focus is on treating orphan diseases.

Headquartered in dynamic Philadelphia, we are a diverse, experienced team united in our goal to break down barriers for people and families affected by genetic diseases. As our name suggests, our investigational, one-time therapies are designed to spark healthy biology, and deliver potentially life-altering transformation for people and families affected by genetic disease. Spark is a member of the Roche Group.

Find Us
Website
Telephone
215-989-1149
Location
3737 Market Street
Suite 1300
Philadelphia
PA
19104
United States
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