Document Control Specialist II

Company: Revance
Location: Newark
Posted on: June 8, 2021

Job Description:

Position Summary:

Responsible for processing document changes and ensuring the adherence with standards of document requests. Assigns and monitors document numbers and reviews documents for accuracy and completeness. Works on assignments that are routine in nature. Normally receives minimal instruction on routine work and receives general instructions on new assignments.

Essential Functions:

• Ensures the correct and timely implementation of document requests in editing of controlled documentation. Verifies own work, checks format and compliance with company templates.
• Performs general word processing support and assists Revance personnel in resolving document format issues.
• Processes document workflows to ensure priority documents are promptly processed to meet timelines.
• Maintains, verifies, and ensures correct and complete database and logbook entries.
• Assists with maintaining systems to ensure integrity and security of all documents containing data relevant to product quality and/or quality systems.
• Provides administration and general troubleshooting support 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.
• Prepares and issues true copies of manufacturing batch records.
• Issuance and archival of 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.
• Supports and maintains archival of offsite storage
• Assists with the document periodic review process.
• Assists with the collection and maintenance of department metrics.
• Provides administrative support for the Select Agent process including correspondence, tracking and archival of Select Agent records.
• Prepares documents for regulatory filings and maintain organized filing system. Assists with Regulatory document publication needs including Regulatory filings (e.g., submissions, correspondence, etc.).
• Maintains and performs audit of control binders to ensure that adequate and accurate distribution has occurred. Implements corrective actions if discrepancies are found.
• Assists in 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.
• Recommends process improvements to improve the quality of the document control system.
• Applies company policies and procedures to resolve a variety of routine issues. Exercises judgment within defined procedures and practices to determine appropriate action.
• Keeps abreast of the basic 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.

Preferred Experience:

• Two to five years of document control experience in the pharmaceutical/biotech industry.
• Works under general supervision; showing a general level of independence.

Preferred Education:

• Typically an AA/AS or equivalent combination of related education and experience.

Preferred Additional Skills

• General knowledge of understanding of Document Control standards, practices, and principles.
• General 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 is proficient with 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.

We are an equal opportunity employer. We are a company where diverse backgrounds, experiences and viewpoints are valued. Revance does not discriminate in practices or employment opportunities on the basis of an individual's race, color, national or ethnic origin, religion, age, sex, gender, sexual orientation, marital status, veteran status, disability, or any other prohibited category set forth in federal or state regulations.

Keywords: Revance, Newark , Document Control Specialist II, Other , Newark, California