Senior Document Control Specialist - Newark, CA | Biospace
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Senior Document Control Specialist

Revance Therapeutics, Inc.

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Location:
Newark, CA
Posted Date:
9/15/2017
Position Type:
Full time
Job Code:
Salary:
Required Education:
Bachelors Degree
Areas of Expertise Desired:

Job Description


Position Summary:

Responsible for leading the maintenance of the document control system and GXP training program while ensuring adherence with checking standards and regulatory guidelines.  Works on assignments that are complex in nature where judgment is required in resolving problems and making recommendations. Normally receives no instruction on routine work and provides recommendations on new assignments. Understands and demonstrates the ability to perform complex document control processes. Provides proposals for continuous improvement and supports the implementation. Develops and leads special projects as requested.

Essential Functions:

•   Provides general guidance for Document Control personnel (including document archival, document processing, workflow prioritization and other daily tasks).
•   May directly supervise junior Document Control personnel.
•   Writes and revises standard operating procedures (SOPs) and work instructions for continuous improvement of documentation systems
•   Creates and maintains document templates while ensuring continuous improvement.
•   Analyzes document changes for completeness.  Ensures the correct and timely implementation of document control requests.  Verifies own work, checks format and compliance with company templates.
•   Performs advanced word processing support and assists Revance personnel in resolving complex document format issues.
•   Maintains the document workflow active log and coordinates the prioritization of urgent document workflows. Processes document workflows to ensure priority documents are promptly processed to meet timelines.
•   Maintains, verifies, and ensures correct and complete database and logbook entries.  Conducts audits on a periodic basis to ensure accuracy and compliance to department processes and procedures.
•   Ensures data integrity and security of all databases and documents containing data relevant to product quality and/or Quality Systems processes.
•   Provides administration and troubleshooting support (i.e. general to complex) for the Electronic Document Management System (EDMS).  Provides internal technical support and escalates as appropriate to EDMS vendor’s technical support
•   Maintains and assigns document numbers, part numbers and lot numbers.
•   Supports the issuance manufacturing batch records, laboratory notebooks and logbooks
•   Maintains master documents and records (both hardcopy and electronic) as required by applicable regulations such that required documentation is retrievable and files are accurate, complete and well organized.
•   Participates in cross-functional teams as a Document Control representative.
•   Provides oversight and maintenance for the archival of offsite storage
•   Supports the document periodic review process.
•   Supports the collection and maintenance of department metrics.
•   Coordinates the administration for the Select Agent process including correspondence, tracking and archival of Select Agent records.
•   Ensures department conducts audit of control binders to ensure that adequate and accurate distribution has occurred. Implements corrective actions if discrepancies are found.
•   Develops and maintains training materials and documentation manuals to ensure accuracy and current information.
•   Develops and delivers training relating to document control processes, templates and electronic systems to Document Control staff and Revance personnel.
•   Provides support with internal and regulatory audits and inspections as required.
•   Leads a special project team within the Document Control function, as needed.
•   Recommends improvements in current document control systems, provides written procedures, reviews and comments on related documentation procedures, and ensures their proper implementation.
•   Applies company policies and procedures to resolve a variety of moderately complex issues.  Exercises good judgment in selecting methods and techniques within defined procedures and practices to determine appropriate action.
•   Keeps abreast of the requirements for compliance in own area of work.  Participates as required in training on regulatory issues affecting own area of work.  Notifies manager of regulatory compliance questions and issues.
•   Follows Environmental, Health and Safety (EH&S) policies and procedures.  Takes responsibility for safety in immediate work area.  Notifies manager of all observed hazardous conditions or unsafe work practices.
•   Performs other related duties and assignments as required and defined by management.

Requirements


Preferred Experience:

•   At least eight years of document control experience in the pharmaceutical/biotech industry or equivalent combination.
•   Works under limited supervision; demonstrating a level of independence and providing recommendations for continuous improvements.
Preferred Education:
•   Typically a BA/BS or equivalent combination of related education and experience.

Preferred Additional Skills:

•   Advanced knowledge of understanding of Document Control standards, practices, and principles.
•   Advanced knowledge of understanding of Quality Systems and applicable GMP regulations and standards.
•   Demonstrates ability to perform detail-oriented work with a high degree of accuracy.
•   Effective written and oral communication skills.
•   Effective time management and interpersonal skills.
•   Possesses initiative and is proactive.
•   Experience with databases and has advanced knowledge of the Microsoft suite (i.e. Word, Excel, Visio, PowerPoint, etc.) and Adobe.
•   Excellent organizational and planning skills.
•   Must work effectively within teams with rapidly changing priorities.
•   Builds productive internal and external working relationships.
•   Demonstrates good coping skills and analytical problem solving skills.

Physical Requirements:

•   Document storage and retrieval may require lifting boxes of documents, carrying documents from one place to another and storing boxes on shelves or in file cabinets.
•   Handling documents requires repetitive motion using a variety of scanning and computer equipment.
•   Should have good keyboarding skills and manual dexterity.