Current jobs related to Document Control Specialist - Indianapolis - RayzeBio
-
QA Document Control Specialist
3 weeks ago
Indianapolis, United States RBW Consulting Full timeQA Document Control Specialist Radiopharma CDMO Indianapolis - Onsite RBW are collaborating with a pioneering leader in the field of nuclear medicine, dedicated to developing innovative therapies for cancer treatment. With a rich history rooted in scientific excellence and a commitment to improving patient outcomes, they consistently push the boundaries of...
-
QA Document Control Specialist
3 weeks ago
Indianapolis, United States RBW Consulting Full timeQA Document Control Specialist Radiopharma CDMO Indianapolis - Onsite RBW are collaborating with a pioneering leader in the field of nuclear medicine, dedicated to developing innovative therapies for cancer treatment. With a rich history rooted in scientific excellence and a commitment to improving patient outcomes, they consistently push the boundaries of...
-
Document Control Specialist
7 days ago
Indianapolis, Indiana, United States Eurofins USA PSS Insourcing Solutions Full timeDocument Control Specialist Job Description**Key Responsibilities:*** Upload new and updated documents into the document repository and populate document properties* Create routing notices for document approval* Monitor routing notice status and set effective dates after document approval* Follow local standards for documentation practices and record...
-
Document Management Professional
2 weeks ago
Indianapolis, Indiana, United States Eurofins USA PSS Insourcing Solutions Full timeJob DescriptionAs a Document Control Specialist at Eurofins USA PSS Insourcing Solutions, you will play a critical role in ensuring the smooth operation of our document management processes.Key Responsibilities:Upload new and updated documents into our document repository and populate document properties accurately.Create routing notices for document...
-
Documentation Control Specialist
6 days ago
Indianapolis, Indiana, United States Rexel Full timeJob SummaryThe Documentation Control Clerk will be based out of our Indianapolis, IN location. This role is responsible for pulling and scanning drawings and ensuring accurate and efficient handling of important documents for the Parts Super Center business.Key ResponsibilitiesRetrieve drawings from designated storage areas based on requests from various...
-
Documentation Control Specialist
9 hours ago
Indianapolis, Indiana, United States Rexel Full timeJob SummaryThe Documentation Control Clerk will be based out of our Indianapolis, IN location and is responsible for pulling and scanning drawings and ensuring accurate and efficient handling of important documents for the Parts Super Center business.Key ResponsibilitiesRetrieve drawings from designated storage areas based on requests from various...
-
Document Control Specialist
2 weeks ago
Indianapolis, United States Eurofins USA PSS Insourcing Solutions Full timeJob DescriptionJob DescriptionCompany DescriptionEurofins Scientific is an international life sciences company, providing a unique range of analytical testing services to clients across multiple industries, to make life and our environment safer, healthier and more sustainable. From the food you eat, to the water you drink, to the medicines you rely on,...
-
Document Control Specialist
14 hours ago
Indianapolis, United States Eurofins Lancaster Laboratories Professional Scientific Services, LLC Full timeCompany DescriptionEurofins Scientific is an international life sciences company, providing a unique range of analytical testing services to clients across multiple industries, to make life and our environment safer, healthier and more sustainable. From the food you eat, to the water you drink, to the medicines you rely on, Eurofins laboratories work with...
-
Document Processing Specialist
2 weeks ago
Indianapolis, United States Phoenix Data Corporation, Inc. Full timeThe Document Processing Specialist is responsible for preparation, scanning, indexing, and other data imaging processes. This position may be cross trained on various aspects of the digitization process. All individuals will be going through an IRS Clearance once hired by Phoenix.Pay: $17.00/hourBenefits: Medical, Dental, Vision, Accident, Critical Illness,...
-
Document Processing Specialist
4 days ago
Indianapolis, Indiana, United States Phoenix Data Corporation, Inc. Full timeJob SummaryThe Document Processing Specialist is a key role at Phoenix Data Corporation, Inc. responsible for preparing, scanning, and indexing documents. This position requires attention to detail, technical skills, and the ability to work in a fast-paced environment.Key ResponsibilitiesPrepare documents for scanning, including receiving, unboxing, and...
-
Documentation Control Clerk
4 months ago
Indianapolis, United States Rexel Full timeThe position of Documentation Control Clerk will be based out of our Indianapolis, IN location! Summary The Documentation Control Clerk is responsible for pulling and scanning drawings and ensuring accurate and efficient handling of important documents for the Parts Super Center business. What You’ll Do Retrieve drawings from designated storage...
-
Indianapolis, United States Janssen & Spaans Engineering Full timeJanssen & Spaans Engineering (JSE) is looking for an Administrative Assistant with Document Control responsibilities. This will include a variety of administrative and clerical tasks. Duties include providing support to our managers, employees and clients, assisting in daily office needs and managing our companys general administrative/document control...
-
Indianapolis, United States Janssen & Spaans Engineering, Inc. Full timeJanssen & Spaans Engineering (JSE) is looking for an Administrative Assistant with Document Control responsibilities. This will include a variety of administrative and clerical tasks. Duties include providing support to our managers, employees and clients, assisting in daily office needs and managing our company’s general administrative/document control...
-
Administrative Assistant with Document Control
3 weeks ago
Indianapolis, United States Janssen & Spaans Engineering, Inc. Full timeJanssen & Spaans Engineering (JSE) is looking for an Administrative Assistant with Document Control responsibilities. This will include a variety of administrative and clerical tasks. Duties include providing support to our managers, employees and clients, assisting in daily office needs and managing our company’s general administrative/document control...
-
Document Specialist
4 weeks ago
Indianapolis, United States Integrated Resources, Inc ( IRI ) Full timeTemperature monitor management • Retrieve Electronic Data Logging Monitors (EDLMs) from incoming shipments and then transfer stored data from the EDLMs to a Client-approved, secured website on a controlled server. • Notify the Distribution Release team that the data is available for evaluation in the secured website. • Alert NALO Operations and QA of...
-
Document Specialist
4 weeks ago
Indianapolis, United States Integrated Resources, Inc ( IRI ) Full timeTemperature monitor management • Retrieve Electronic Data Logging Monitors (EDLMs) from incoming shipments and then transfer stored data from the EDLMs to a Client-approved, secured website on a controlled server. • Notify the Distribution Release team that the data is available for evaluation in the secured website. • Alert NALO Operations and QA of...
-
Technical Writer
4 weeks ago
Indianapolis, United States Bureau Veritas Full timeCompany Overview: ATL, A Bureau Veritas Company is a professional services organization with an ever-broadening service portfolio to support FDA-regulated products and companies worldwide. Providing scientific, engineering, and regulatory laboratory services, we seamlessly leverage our expertise within the consumer product goods, pharmaceutical, and...
-
Loan Documentation Specialist
5 days ago
Indianapolis, United States The National Bank of Indianapolis Corporation Full timeLoan Documentation SpecialistPrimary Duties and Responsibilities: The teammate is accountable for preparing and reviewing loan documentation and identifying exceptions, while providing the highest quality of service to every customer. Essential Functions: Prepares consumer and/or commercial loan packages for closing in a timely, accurate and complete...
-
Inventory Control Specialist
2 weeks ago
Indianapolis, United States Keurig Dr Pepper Full timeInventory Control Specialist - Indianapolis, IndianaHiring Immediately!The Inventory Control Specialist checks inventory figures, postings and documents to ensure accuracy. Shift and Schedule: Full-timeSunday - Thursday5:00AM - finished Flexibility to work overtime and weekends as needed is required Position ResponsibilitiesConduct a physical inventory of...
-
Quality Control Specialist
3 weeks ago
Indianapolis, Indiana, United States FFP Full timeJob OverviewAs a Quality Control Specialist at FFP on the 2nd shift, you will be integral in upholding the safety and excellence of our products. Your responsibilities will include conducting thorough inspections and evaluations of raw materials, in-process items, and finished goods. You will also engage in the maintenance and troubleshooting of databases,...
Document Control Specialist
4 months ago
Job Title: Document Control Specialist
Location: Indianapolis
NH: 39
Background
RayzeBio is a dynamic biotechnology company headquartered in San Diego, CA. Launched in late 2020 and recently acquired by Bristol Myers Squibb (BMS) as a wholly owned subsidiary, the company is focused on improving survival of people with cancer by harnessing the power of targeted radioisotopes. RayzeBio will operate as a standalone entity within the BMS organization, maintaining its biotech culture with the opportunity to leverage the best-in-class oncology capabilities of BMS. RayzeBio is developing innovative drugs against targets of solid tumors. The lead asset, RYZ101, is in Phase 3 testing for patients with gastroenteropancreatic neuroendocrine tumors (GEP-NETs), as well as earlier stage testing for patients with small cell lung cancer (SCLC) and breast cancer. Led by a successful and experienced entrepreneurial team, RayzeBio aims to be the global leader in radiopharmaceuticals.
Summary
The Document Control Specialist is responsible for the tactical oversight and maintenance of document control system for a new Radiopharmaceutical facility in Indianapolis, IN. The Document Control Specialist will be a primary contact point for document control support. This position will utilize quality assurance knowledge in maintaining the quality program to be ready for clinical development and GMP commercial operations. Additional responsibilities may include providing support for corporate activities.
Job Responsibilities
Essential duties and responsibilities include the following. Other duties may be assigned.
- Manage the process for the creation, review, approval, and issuance of GxP controlled site documents and records including batch records, logbooks, forms, procedures, protocols, templates, and reports.
- Manage electronic document management system (EDMS) document lifecycle workflows and assignment of reviewers / approvers and training tasks.
- Review the format and metadata of new documents to ensure compliance with approved templates, procedures and EDMS requirements.
- Provide guidance to document initiators, owners, and users to ensure compliance with all applicable procedures / regulations and assist users with EDMS workflow related issues.
- Manage the periodic review of controlled documents and partner with document owners to ensure periodic reviews are completed within the required timelines.
- Coordinate and liaise with other departments to facilitate uniform quality standards for the site.
- Ensure that compliance to the training program is maintained and updated as needed.
- Process DCR packages and review for correctness and completeness; monitor and update in-process documents.
- Create, assign, and archive QA controlled lab notebooks and logbooks.
Education and Experience
• Specialist: BS/MS in a Science related discipline preferred
o 3-5 years of quality assurance experience
• Pharmaceutical and GMP experience preferred.
• Experience working with FDA or other federal and state regulatory bodies.
Skills and Qualification
• Highly motivated and organized professional with the ability to work independently.
• Working knowledge of 21 CFR Parts 11, 210, and 211
• Very personable with strong communication skills
• Excellent professional ethics, integrity, and ability to maintain confidential information.