Document Control Specialist II
Posted on: June 8, 2021
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.
- 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
- Maintains and assigns document numbers, part numbers and lot
- Prepares and issues true copies of manufacturing batch
- 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
- Provides administrative support for the Select Agent process
including correspondence, tracking and archival of Select Agent
- Prepares documents for regulatory filings and maintain
organized filing system. Assists with Regulatory document
publication needs including Regulatory filings (e.g., submissions,
- 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
- 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.
- Two to five years of document control experience in the
- Works under general supervision; showing a general level of
- 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
- Builds productive internal and external working
- Demonstrates good coping skills and analytical problem solving
- 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
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