- 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.
- 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.
-
Document Control Specialist
2 days ago
Insight Global Philadelphia, United StatesInsight 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 Manufac ...
-
Inventory Control Specialist
2 weeks ago
Wapt Philadelphia, Pennsylvania, United States PermanentOverview: · 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, exc ...
-
Inventory Control Specialist
2 weeks ago
WAPT Philadelphia, United StatesOverview · 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, exce ...
-
Project Controls Specialist
1 week ago
Excel Engineering Inc Phila, United StatesJob TypeFull-timeDescriptionExcel Engineering, Inc. is seeking a team-oriented, highly motivated individual for a full-time Project Controls Specialist. This is for our power utility client in Minneapolis, MN.The candidate will provide cost tracking/cost forecasting on client maj ...
-
Inventory Control Specialist
2 weeks ago
Onsite Personnel LLC Philadelphia, United StatesJob Description · Job DescriptionResponsibilities: 2nd Shift Inventory Control Specialist: Sunday - Thursday: 4 PM - 12:30 AM:Records and Maintains control of all inventory items purchased and produced · Run a series of inventory reports on daily, weekly, or monthly basis · Valid ...
-
Inventory Control Specialist
2 weeks ago
WuXi AppTec Philadelphia, United StatesOverview · 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, exce ...
-
Inventory Control Specialist
1 day ago
Honor Foods Philadelphia, United StatesJoin Our Team as an Inventory Control Specialist · Purpose of This Position: As an Inventory Control Specialist, you'll play a crucial role in ensuring the accuracy of our inventory and maintaining product quality. Your daily and weekly tasks will involve counting inventory, anal ...
-
Logistics Control Specialist
3 weeks ago
PCi Corporation Philadelphia, United StatesLife changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients. · We are PCI. · Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to ...
-
GLP Quality Control Specialist
3 weeks ago
Cabaletta Bio Philadelphia, United StatesPhiladelphia, PACabaletta Bio (Nasdaq: CABA) is a clinical-stage biotechnology company focused on developing and launching targeted, potentially curative, cellular therapies for patients with autoimmune diseases. The CABATM platform includes two strategies to treat and potentiall ...
-
Inventory Control Specialist
3 weeks ago
Cooper University Hospital Camden, New Jersey, United States PermanentAbout Us: · At Cooper University Health Care, our commitment to providing extraordinary health care begins with our team. Our extraordinary professionals are continuously discovering clinical innovations and enhanced access to the most up-to-date facilities, equipment, technologi ...
-
Sr Quality Control Specialist, Flow Cytometry
3 weeks ago
Proclinical Staffing Philadelphia, United States Full time, FreelanceProclinical is seeking a dedicated Senior Quality Control Specialist. This role is pivotal in reviewing test methods and raw data for lot release and requires a solid understanding of Quality Control. The ideal candidate will have practical knowledge of GMPs and regulatory requir ...
-
Quality Control Specialist
2 weeks ago
Adaptimmune Phila, United StatesJob Description Job Description Adaptimmune 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, t ...
-
Iovance Biotherapeutics, Inc. Philadelphia, United StatesIovance Biotherapeutics is a growing, late-stage company focused on the development and commercialization of novel cancer immunotherapies. Iovance is seeking a Specialist, Quality Control, Operations Strategy, who will support the long-term sustainability of the Lean Labs initiat ...
-
Quality Control Specialist
3 weeks ago
Adaptimmune Therapeutics, plc Philadelphia, United StatesThe Quality Control Specialist will be responsible for conducting /coordinating in-process environmental monitoring of cGMP suites, finished product safety tests (endotoxin, sterility), and stability testing associated with Adaptimmune drug products. Control Specialist, Quality C ...
-
Quality Control Specialist
3 weeks ago
Adaptimmune Philadelphia, United StatesAdaptimmune 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, autologou ...
-
Inventory Control Specialist
2 weeks ago
Wapt Philadelphia, United StatesOverview: · **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, ...
-
Inventory Control Specialist
23 hours ago
KRG Enterprises, Inc. Philadelphia, United StatesCustom store fixture and millwork manufacturer in Northeast Philadelphia, PA is seeking an Inventory Control Specialist for Hardware Department. Detail oriented, self-motivated individual needed for fast paced environment. Requires basic knowledge of furniture hardware and fasten ...
-
Quality Control Specialist
1 week ago
Amer Technology, Inc Philadelphia, United States_**Work schedule: 2nd Shift, 100% onsite**_ · - **Wed - Sat, 12pm - 10pm (2)**_ · - **Sun - Wed, 12pm - 10pm (1)**_ · The training period will be 3-4 weeks and will be Monday through Friday on 1st shift. · **Consultant's day to day responsibilities**: · - Initiating investigation ...
-
inventory control specialist
3 weeks ago
Cooper University Health Care Camden, United States· INVENTORY CONTROL SPECIALIST · Camden, NJ · Job ID 16306 Job Type Full Time · Shift Day · Specialty Purchasing · Apply · About us · At Cooper University Health Care, our commitment to providing extraordinary health care begins with our team. Our extraordinary professionals ar ...
-
Inventory Control Specialist I
3 weeks ago
BFS Group Gloucester City, United StatesInventory Control Specialist I · Gloucester City NJ Millwork - 850 Charles St , 850 Charles St, Gloucester City, New Jersey, United States of America Req #38832 · Tuesday, March 26, 2024 · Ignite your career at Builders FirstSource, America's largest supplier of building material ...
Document Control Specialist - Philadelphia, United States - Spark Therapeutics Inc
Description
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
Spark Therapeutics does not accept unsolicited resumes/candidate profiles from any source other than directly from candidates. Any unsolicited resume/candidate profile submitted through our website or to personal email accounts of employees of Spark Therapeutics are considered property of Spark Therapeutics and are not subject to payment of agency fees.
