QA Document Control Specialist
The Document Control Specialist will manage documents (both electronic and paper copies) within Quality Assurance, Regulatory Affairs, and other key departments at Neurocrine to ensure that all GXP regulated documents are filed systematically and are easily retrievable. Duties will include processing GXP records, lifecycle management of records, maintenance of the document database, and troubleshooting document issues and requests.
Essential Duties and Responsibilities (including, but are not limited to):
- Receive, file, and maintain all GXP documents, including but not limited to standard operating procedures (SOPs), test methods, specifications, incident reports, CAPAs, Product Complaints, computer system validation, etc.
- Manage a Document Repository that tracks the receipt, revisions and archiving of all GXP documents; and prepare supportive process workflows and procedures to maintain efficiency and access for all users.
- Maintain GXP audit files and assist with entry, tracking, and archiving of audit records.
- Oversee and administer document lifecycle management as well as the Document Change Request process.
- Assist in the maintenance of training records and documentation within our Learning Management System.
- Assist with and/or write SOPs for the creation and development of processes, archiving, and operations related to Document Control.
- Perform review of documents submitted through the change control process for format, completeness, review and approvals. Issue controlled document copies to internal and externals requestors.
- Process document requests to be used in-house or sent to CSPs in a timely manner.
- Provide guidance and training to staff regarding document control processes.
- Other essential duties as assigned.
- Knowledge of quality systems and regulatory compliance requirements within pharmaceutical or biotech environment.
- Strong EDMS and computer skills to include Excel, Word, Adobe Acrobat, PowerPoint, Visio, DocuSign, Compliance Wire, Open Text CS10, Veeva Vault, and Veeva Quality Docs.
- Attention to detail, critical thinker, and effective organization skills required.
- Strong communication and proficient soft skills.
- Works well in a team environment with the ability to drive results.
- Ability to solve problems and work collaboratively in a team environment.
Education and/or Experience:
- BS. Degree in a related scientific field desired. A minimum of 4 years of experience within the pharmaceutical/biotech field performing document management and electronic document management.