Careers
Job Posting: Sr. Document Control Coordinator
Indianapolis, IN
Contract
Position Overview
This Document Control position is concerned with the generation and maintenance of Document Control records and departmental SOPs and batch records. The incumbent will be responsible for the day to day tasks in this key quality system through adherence to company and departmental procedures.
Major Position Activities & Responsibilities
- System Administrator of the electronic documentation system: supporting users by answering questions, one-on-one training, trouble shooting, working with IT on specific cases, and providing support for any changes made to the system via Modification Change Controls
- Administrator for Training System: updating/creating training materials (JQRs and TACs), creating curriculums/training for procedures/updates/processes, and assigning training to the required individuals
- Technical judgment in decision making and technical training of departmental peers
- Initiating/owning/investigating exceptions and issues related to Document Control in the Quality Tracking System
- Processing change orders, drafting documents, editing and processing of documents in the electronic document system
- Answering questions, customer assistance with drafting/ requests from individual users
- Issuance and logging of batch records, checksheets and associated forms
- Maintaining electronic document repositories and document sharefile directories
- Logging in/auditing/searching/filing of documents
- Issuance, tracking and archiving of all LUMAC, QC Data, and other GMP logbooks
- Preparation of departmental metrics
- Document Control representative on inter departmental teams and projects
- Expediting requests to the Doc Center
- Updating/creating Document Control SOPs
- Processing/expediting document requests from Regulatory, and placing them into the designated site for each submission
- Performs special projects and other duties as assigned
- Providing documentation support during regulatory inspections/external audits of the facility
- Serves as a delegate for Manager, Training and Document Control when needed
Scope
- This position is non-supervisory, and performance is tracked through various departmental and company metrics. The incumbent is expected to trouble shoot Doc Center problems.
Background Qualifications
- 4-year college degree or equivalent experience in document control or related field
- 1 year or more Pharmaceutical experience with cGMPs preferred
- Previous experience with electronic document management system(s)
- Desktop publishing including proficiency in WORD, Excel, Access, Photo Editor, and Adobe Acrobat preferred
- Ability to successfully follow up on projects to achieve resolution and completion
- Excellent communication skills, both written and verbal
- Detail-oriented, flexible, able to interact well with varied organizational levels, and excellent teamwork skills
- Some lifting of file boxes required up to 30 lbs.
