Document Control Specialist
3 weeks ago
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 unlock the power of gene therapy to accelerate healthcare transformation.
We don’t follow footsteps. We create the path.
**Primary Duties**
The QA Document Control Specialist will work to develop, deploy, and support the Veeva Quality Document System, manages, and tracks all GMP documentation. Following Spark SOPs, the incumbent 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 individual 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 document management system.
**Responsibilities**
- Manage and maintain controlled documents in Electronic Document Management System (EDMS) ensuring documents go through controlled documents life cycle in accordance established procedures.
- Independently review SOPs, form content and exercise judgment to provide suggestions to document authors 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 identified vendors.
- Provide site training on EDMS workflow to other departments before granting user 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 EasyVista (EV) on all incidents and requests for the EDMS and close all tickets in a timely manner.
- Serve as an administrator of the EDMS including user account management, system configuration, troubleshooting and work with EDMS vendor(s).
- Provide documentation support during 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.
- Implement and utilize advanced Word processing and automation features of MS Office software.
**Education and Experience Requirements**
- BS / BA in Biology, Chemistry, Engineering, related science discipline or equivalent experience is required.
- Generally, 2-5 years of experience in working with documentation in a regulated industry.
- Computer literacy required; advanced Microsoft Office skills (Outlook, Word, Excel, PowerPoint)
- Knowledge of GMP concepts and guidelines.
- Experience with document control activities.
- Experience with document control systems.
- 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 adapt to frequent changes, delays, or unexpected events.
- Ability to follow established policies, 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.
- Experience in automating process utilizing MS Office products.
- This position must be able to think critically and solve documentation problems.
- 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.
- This position may require occasional shift work, including weekends, off hours and holidays as needed.
**Nearest Major Market**:Philadelphia
-
Document Control Specialist
3 weeks ago
Philadelphia, United States Spark Therapeutics Full timeJoin 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 unlock the power of gene therapy to accelerate healthcare transformation. We don’t follow footsteps. We create the path. **Primary Duties** The QA Document Control...
-
Project Controls Specialist Ii
3 weeks ago
Philadelphia, United States TYLin Full timeTYLin is a globally recognized, full-service infrastructure consulting firm committed to providing innovative, cost-effective, constructible designs for the global infrastructure market. With over 3,000 employees throughout the Americas, Asia, and Europe, the firm provides support on projects of varying size and complexity. Together, we enhance conventional...
-
Document Control Specialist
1 week ago
Philadelphia, United States Insight Global Full timeInsight Global is hiring for a Documentation Coordinator in Philadelphia. The Technical Writer will be respinsible for developing, reviewing, and revising documentation in a chemical manufacturing setting. Must Haves: Technical writing experience Preferably Chemical Manufacturing Industry SOP Writing Documentation control 1-2 years of technical writing...
-
Document Control Specialist
2 weeks ago
Philadelphia, United States Insight Global Full timeInsight Global is hiring for a Documentation Coordinator in Philadelphia. The Technical Writer will be respinsible for developing, reviewing, and revising documentation in a chemical manufacturing setting.Must Haves:Technical writing experiencePreferably Chemical Manufacturing IndustrySOP WritingDocumentation control1-2 years of technical writing...
-
Document Control Specialist
2 weeks ago
Philadelphia, United States Insight Global Full timeInsight Global is hiring for a Documentation Coordinator in Philadelphia. The Technical Writer will be respinsible for developing, reviewing, and revising documentation in a chemical manufacturing setting.Must Haves:Technical writing experiencePreferably Chemical Manufacturing IndustrySOP WritingDocumentation control1-2 years of technical writing...
-
Document Controller
2 months ago
Philadelphia, United States Airswift Full timeAirswift is hiring for a Document Controller / Admin to work on contract assignment through Airswift in our client's project engineering department in support of their facility expansion project. This position will be based in the engineering office in Philadelphia, PA. We're looking to hire the right person immediately.Job ResponsibilitiesAdministrative...
-
Document Controller
4 weeks ago
Philadelphia, United States Airswift Full timeAirswift is hiring for a Document Controller / Admin to work on contract assignment through Airswift in our client's project engineering department in support of their facility expansion project. This position will be based in the engineering office in Philadelphia, PA. We're looking to hire the right person immediately.Job ResponsibilitiesAdministrative...
-
Document Imaging Specialist
3 days ago
Philadelphia, United States CapLeo Global Full timePosition Title: Document Imaging Specialist Location: Ogletown Stanton Road, Newark, DE 19178 Duration: 13 weeks with possibility of extension Shift hours: 5 am - 1:30 pm Mon-FriJob Description: Responsible for preparation and scanning of medical records received by HIMS. Assures readiness of records for transport to offsite vendor for prep, scan and...
-
Document Control Clerk
1 week ago
Philadelphia, United States Herzog Full timeOverview: Herzog Contracting Corp. is currently seeking **Document Control Clerk **in **Philadelphia, PA** to join our team. The Document Control Clerk is responsible for operating various document reproduction equipment and maintaining document storage files for originals and/or revisions, and by utilizing the document control process. **Duties and...
-
Construction Inspectors
4 weeks ago
Philadelphia, United States Whitman, Requardt & Associates, LLP Full timeJob DescriptionJob DescriptionAt Whitman, Requardt & Associates, LLP, we are "People Focused and Project Driven". We have been in business for more than 105 years and we are known for our quality work and quality employees. This is your chance to join our team - help us to design the infrastructure and buildings that improve the world!We are looking for...
-
Document Specialist
3 weeks ago
Philadelphia, United States Cozen O'Conner Full timeThe Philadelphia office is seeking a full-time Document Specialist to work in office on Wednesday, Thursday and Friday, and remote Saturday and Sunday. Work hours are 9-5 ET. **DUTIES AND RESPONSIBILITIES** - Knowledgeable in Adobe Pro. In addition to this: - Converting PDFs to Word - Reduce file size - Using the editing tool in PDFs - Typewriter tool to...
-
Inventory Control Specialist
4 weeks ago
Philadelphia, United States Wapt Full timeOverview: **WuXi Advanced Therapies** is a leading global cell and gene therapy contract, testing, development, and manufacturing organization (CTDMO) that is dedicated to advancing the development and commercialization of cell and gene therapies. Our values include innovation, excellence, and collaboration, which are reflected in our mission to accelerate...
-
Quality Assurance Document Control
3 weeks ago
Philadelphia, United States Catalent Inc Full timeQuality Assurance Document Control Position Summary Catalent Pharma Solutions in Philadelphia, PA is hiring for a Quality Assurance Document Control. The Quality Assurance Document Control individual is responsible in preparing customer files, review and approve batch records, and release batch records and finished product. The Quality Assurance Document...
-
Inventory Control Specialist
4 weeks ago
Philadelphia, United States WAPT Full timeOverview WuXi Advanced Therapies is a leading global cell and gene therapy contract, testing, development, and manufacturing organization (CTDMO) that is dedicated to advancing the development and commercialization of cell and gene therapies. Our values include innovation, excellence, and collaboration, which are reflected in our mission to accelerate the...
-
Inventory Control Specialist
4 weeks ago
Philadelphia, United States WAPT Full timeOverviewWuXi Advanced Therapies is a leading global cell and gene therapy contract, testing, development, and manufacturing organization (CTDMO) that is dedicated to advancing the development and commercialization of cell and gene therapies. Our values include innovation, excellence, and collaboration, which are reflected in our mission to accelerate the...
-
Document Specialist
3 weeks ago
Philadelphia, United States M. BURR KEIM COMPANY Full timeWe have an immediate full-time opening for a Document Specialist / Customer Service Representative. Must be able to work full-time. **Position Summary** - Answer telephone calls and multi-task - Have proficiency in Microsoft Outlook and Word - Be friendly, outgoing, and have strong customer relation skills - Be detail oriented and follow instructions - Be...
-
Doc & Data Control Specialist - DCS24-09699
7 days ago
Philadelphia, United States NavitsPartners Full timeJob DescriptionJob DescriptionJob Title: Doc & Data Control Specialist Location: Anywhere in US - EST time zone preferable - EST working scheduleDuration: 11 MonthsExperience: Minimum of 5 years Sourcing or Supply Chain Management experienceResponsibilities:Review and management of engineering documentation that defines supplier requirements on a purchase...
-
Quality Control Specialist
4 weeks ago
Philadelphia, United States Adaptimmune Full timeJob DescriptionJob DescriptionAdaptimmune is a fully integrated cell therapy company, designed and built from the ground up with four U.K.- and U.S.-based biotechnology hub locations. Our comprehensive capabilities and teams include preclinical research, clinical development, translational sciences, autologous and allogeneic manufacturing, and in-house...
-
Inventory Control Specialist
4 weeks ago
Philadelphia, United States Onsite Personnel LLC Full timeJob DescriptionJob DescriptionResponsibilities: 2nd Shift Inventory Control Specialist: Sunday - Thursday: 4 PM - 12:30 AM:Records and Maintains control of all inventory items purchased and producedRun a series of inventory reports on daily, weekly, or monthly basisValidate received merchandise to description and package details from original purchase...
-
Quality Assurance Document Control Supervisor
4 weeks ago
Philadelphia, United States Catalent Full timeQuality Assurance Document Control Supervisor Position Summary Catalent Pharma Solutions in Philadelphia, PA is hiring a Quality Assurance Document Control (QADC) Supervisor. The QADC Supervisor will supervise the team and activities associated with batch record documentation, reviewing and approving batch records, and releasing batch records and finished...