Thermo Fisher Scientific Quality Specialist I in Fremont, California

Job Description

When you’re part of the team at Thermo Fisher Scientific, you’ll do important work, like helping customers in finding cures for cancer, protecting the environment or making sure our food is safe. Your work will have real-world impact, and you’ll be supported in achieving your career goals.

The Quality Specialist will maintain aspects of Document Control by processing and implementing labeling changes to conform with current Good Manufacturing Practices (cGMP), Design Control Procedures, and approved corporate/company-wide procedures. This individual will create, process, and implement change requests in an electronic system. Compile and maintain control records and related files to release documents to manufacturing and other departments. Update master documents to reflect approved changes; update master indexes/files to ensure they supersede old revisions. Receive minimum instructions on routine tasks, and directed instructions on new assignments.

Key Responsibilities:

The Quality Specialist is responsible for document handling ensuring compliance to ISO and FDA Document Control requirements per site SOP. Notify Supervisor of document control system issues and recommend compliant solutions. Support operation by assigning part numbers for parts and controlled documents, and entering Item Master Request (IM), Bill of Material (BOM) into the Material Resource Planning (MRP) software. Review and create change packages, assign change numbers, track open changes and maintain document control files (paper and electronic). Generate new and revised documents that are accurate and supplied in a timely manner. Participate in Document Control validation projects as related to streamlining, and continuous improvement of document structure and templates. This position has the authority to reject incomplete documents submitted for processing. This position will also receive and file Device History Records and ensure records are accurate and completed per Good Documentation Practices. Support metrics requirements across the facility related to records, documents and changes. As requested provide document numbers and lab notebooks and tracking number to R&D.

Minimum Requirements/Qualifications:

  • High school diploma or equivalent; degree is a plus.

  • Minimum of 1-3 years work related experience.

  • Previous training and experience in Document Control a plus.

  • Experience in Material Resource Planning (MRP) or Enterprise Resource Planning (ERP) software a plus.

  • Exposure to reviewing accuracy of native labeling files and revision control is highly desirable.

  • Ability to work in high-pressured deadline oriented environment.

  • Good skills at alpha and numeric sequencing and filing with good proofreading/editing skills.

  • Must be detail-oriented requiring a high degree of accuracy.

  • Proactive in suggesting improvements in workflow.

  • Must have excellent customer service and listening skills.

  • Basic arithmetic skills including the ability to calculate figures and amounts and to interpret the data.

  • Must have the skills to work as a strong contributor in a team effort.

  • Ability to manage multiple customers such as project management, manufacturing operations, document control is required.

  • Ability to quickly respond to outside customer demands working with Thermo Fisher Scientific internal organizations will be essential.

  • Proficiency with Word, Excel, Access, and PowerPoint.

  • Proven track record in working with major document management system such as Agile. Experience initiating and working in change management process will be required.

This position has not been approved for Relocation Assistance.

At Thermo Fisher Scientific, each one of our 55,000 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 at 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.