- Oversee the receipt, filing, and maintenance of all GXP documents, including but not limited to standard operating procedures (SOPs), test methods, specifications, incident reports, CAPAs, Product Complaints, computer system validation, etc.
- Design and implement an enterprise-wide 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.
- Responsible for the integration of the Learning Management System (Training System) with the new document repository.
- Administration and 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 Quality Systems / 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.ADDITIONAL RESPONSIBILITIES:
- Ensure ALCOA principles of the Document Control system.
- Assign document numbers.
- Provide support in processing contract organization requests (e.g., coordinating review and approval of contract organization-controlled documents) in a timely and efficient manner.
- Review Documented procedures and other documents to ensure compliance to relevant cGMP/cGCP and cGLP requirements.
- Coordinate the approval process, including facilitation and execution of documentation through document change control process.
- Organizing, filing, scanning, and PDFing of all Quality System Documentation as required
- Update and Maintenance of all Document Control logs.
- Provide relevant training on Document Control procedures.
- Perform other related duties and responsibilities to support Document Control and QA as defined by management.
- Create, implement, and maintain Document Control System for Technical Protocols and Reports.
- File Stability and other misc. QC data.
Qualifications: - Knowledge of quality systems and regulatory compliance requirements within biopharmaceutical environment.
- Strong EDMS and computer skills to include Excel, Word, Adobe Acrobat, PowerPoint, Visio, DocuSign, and experience in LMS and eQMS systems and administration.
- 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 5 years of experience within the pharmaceutical/biotech field performing document management and electronic document management. Nurix Therapeutics, Inc. is committed to protecting and respecting your privacy and personal information, including information collected by Nurix when you apply for a job with Nurix or in the course of your employment with Nurix. By applying for a position at Nurix, you agree to our collection and use of personal information as described in our Privacy Policy ( ).
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Senior Specialist - San Francisco, United States - Nurix Therapeutics
Description
Summary:
The Quality Systems Senior Specialist / Associate Manager will manage documents (both electronic and paper copies) within Quality Assurance and other key departments at Nurix Therapeutics to ensure that all GXP regulated documents are filed systematically and are easily retrievable. The core function consists of, but is not limited to, managing, developing, operating, and maintaining the Document Control System (DOT COMPLIANCE) and SharePoint used to create, maintain, and control all Quality System Documentation, which includes, but is not limited to, SOPs, protocols, instructions, guidelines and related documents.Essential Duties and Responsibilities (including, but are not limited to):
