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Document Control Analyst

Company: Thermo Fisher Scientific
Location: Carlsbad
Posted on: January 16, 2022

Job Description:

**Document Control Specialist** When you join us at Thermo Fisher Scientific, you'll be part of a smart, driven team that shares your passion for exploration and discovery. With revenues of $22 billion and the largest investment in R&D in the industry, we give our people the resources and opportunities to make significant contributions to the world. **Location/Division Specific Information** The role is responsible for Document Control Management of a recently built enzyme manufacturing facility serving pharmaceutical customers. This operation is part of our Biosciences Division (BID), part of our Life Sciences Solutions Group (LSG). BID is experiencing an outstanding growth supporting exciting markets: Academia, Research, Biotech, Pharma, Cell and Gene Therapy and Medical Devices. **How will you make an impact?** We are looking for a self-driven, experienced and resourceful Document Control Specialist to support with the buildout of our document control system, ensuring compliance to all applicable standards. **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. At Thermo Fisher Scientific, each one of our 70,000 extraordinary minds has a unique story to tell. Join us and contribute to our singular mission-enabling our customers to make the world healthier, cleaner and safer. Apply today! http://jobs.thermofisher.com _Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status._ Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.

Keywords: Thermo Fisher Scientific, San Diego , Document Control Analyst, Professions , Carlsbad, California

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