Job Listing Description

Document Control Analyst/ Labeling Specialist

PDS Tech is seeking candidates for a Document Control Analyst position in Carlsbad, CA

What will you do?            

Day-to-day support of the document control workflow, which is the vehicle to execute the request for changes within a ISO 9001 and Pharmaceutical GMP Quality Management System.
Support the coordination, preparation and implementation of controlled documents via Document Change Orders (DCOs) and Engineering Change Requests (ECRs).
Review and edit product documentation for consistency in content. Interact with appropriate departments/sites to resolves discrepancies.
Assist with global document review boards ensuring that document changes which impact multiple sites are appropriately updated congruently to prevent process drift.
Drive continuous improvement of Document Control process by employing Practical Process Improvement concepts, managing metrics, reporting and communicating internally to Leaders and diverse audiences.
Determine required approvers and route corresponding DCO/ECR in Agile. On completion of change, ensure manufacturing documentation is available at the point of use. Provide notification to appropriate departments, where applicable.
Prepare physical binder of Quality Management System (QMS) documents for audit support.
Train staff to document control processes, Good Documentation Practices (GDP), etc.
Compile master data for entry into Agile document management system
Transfer documents to new approved templates
Perform other duties and cross training, as assigned
How will you get here?


Associate’s degree from accredited college/university or equivalent experience. Bachelor’s degree in Science, Engineering, Biochemistry, Biotechnology, Biology, or Biomedical Engineering preferred.

Requires a minimum of 2-3 years relevant experience in a regulated document control environment.
Strong working knowledge of computer applications and current software (Microsoft Excel, Outlook, Word, Project and PLM/ERP system).
Knowledge, Skills, Abilities

Experience with Agile and MasterControl electronic document control systems preferred.
Works independently on new and on-going assignments.
Identifies and solves problems using established business rules and procedures.
Detail oriented and accurate.
Strong verbal and written communication skills.
Continuous improvement minded.
Knowledge of quality standards (e.g., 21 CFR Part 820, ISO 9001, ISO 13485, MDSAP, excipient manufacturing regulations) and 21 CFR part 210/211, ICH Q7 and Eudralex volume 4 experience preferred.
Job Number: 2110126151
Job Location: Carlsbad, CA
Duration: 9 months
Input Date: 03/05/2021
Last Updated: 04/08/2021
Attention: Clyde Callwood
Address: 3922 COCONUT PALM DR STE 100
City, State: TAMPA, FL 33601
800 Phone: 866/224-2745

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