Manufacturing Documentation Specialist II

    Thermo Fisher Scientific Inc.
    Miami, FL
    Full-time
    Similar jobs pay $9.49 - $15.26

    Job Description

    How will you make an impact?

    Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue exceeding $25 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, improving patient diagnostics and therapies or increasing productivity in their laboratories, we are here to support them. Our global team of more than 75,000 colleagues delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services and Patheon. For more information, please visit www.thermofisher.com.

    Responsibilities:
    • Administratively support Manufacturing Batch Record procedures for document issuance, control and review
    • Creating and / or revising procedures and work instructions and process them in quality document management system
    • Maintain files and records supporting site Document Control quality management process.
    • Revise and route document change requests and document approval activities in accordance with GMP and quality standards.
    • Maintains and coordinates documentation as required for manufacturing such as Batch Records, Logbooks, Forms, and other documentation activities as required. Prepare all documentation as assigned.
    • Supports the creation of SOPs, manufacturing batch records and other GMP required documentation by formatting and word processing, as needed.
    • Receives and verifies manufacturing batch records. Shall review work orders/batch records and be able to verify all components and correct lot numbers to be used are correct.
    • Supports the review of documents for completeness and accuracy. Review final batch record/work orders information for completeness.
    • Keeps abreast of the basic requirements for compliance in own area of work and complies with those requirements. Brings regulatory compliance questions/issues to the attention of management.
    • Promotes a safe work environment. May provide recommendations on maintaining the safety of the work environment. Participates in Environmental Health and Safety programs. Addresses corrective actions whenever a hazard is identified. Notifies supervisor of all observed hazardous conditions or unsafe work practices.
    • Provide recommendations to support systems that continuously improve product/process quality and product availability, reduce cost, and increase production capability.
    • Performing Shop Floor transactions in the Enterprise Resource Planning (ERP) System.
    • Performing financial variance reviews prior to full completion of Work Orders.
    • Plan, develop, organize, write and edit operational procedures and manuals
    • Create user documentation for a variety of material, including job aides and work instructions
    • Work with internal teams to obtain in-depth understanding of all equipment and documentation requirements.
    • Excellent interpersonal skills are required. Teamwork is essential as coordination between Documentation Control personnel is mandatory.
    • Overtime/Off Shift On-site support may be required
    • All other duties as assigned by Supervisor
    Education & Experience
    • Minimum 3 years in working with computer application and handling electronic document management systems in a GMP Environment.
    • Knowledge in Microsoft Office tools and Document Quality Management System.
    • Associate Degree or equivalent experience 3 years with demonstrated proficiency / knowledge in documentation systems in a regulated GMP environment. Basic knowledge of scientific terms, concepts and acronyms useful. Ability to learn, apply and train others in new systems as introduced.
    • Strong computer literate and experience using "Windows" computer software applications such as Word and Excel.
    • Experience in a electronic document management systems and/or Training System.
    • At least 3 years of Pharmaceutical or Medical Device experience desired.
    • Strong communication skills both verbal and written
    • Strong attention to detail
    • Ability to work independently
    • Self-starter
    Working Conditions:
    • Exposure to industrial machinery, sharp and moving parts, electrical and other energy sources.
    • Personal Protective Equipment (PPE) required including but not limited to lab coats, hair / beard covers, shoe covers, gloves, ear protection, eye protection and specialized cleanroom suits and head coverings as required.
    • Exposure to high frequency noise
    • Ability to work in environment with interruptions/urgent requests and resume previous activities seamlessly.
    If you are an individual with a disability who requires reasonable accommodation to complete any part of our application process, click here for further assistance.

    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.
    Posting ID: 558255721Posted: 2020-05-21