Work Schedule
Standard (Mon-Fri)
Environmental Conditions
Office
Job Description
Join our team at Thermo Fisher Scientific Inc. as an FSP-Scientific/Technical Writer and become a key player in our engineering department! This outstanding opportunity allows you to work in a world-class environment, contributing to groundbreaking advancements and ensuring flawless documentation.
Key Responsibilities:
- Ensure compliance with cGMPs, SOPs, and Thermo Fisher standards of documentation to support sterile manufacturing.
- Coordinate the preparation of GMP/GLP documents such as Standard Operating Procedures, Production Forms, batch records, Logbooks, and Laboratory Notebooks.
- Support in developing metrics and key indicators for the area.
- Support the daily activities to ensure the manufacture of quality parenteral products for development and clinical needs.
- Report and maintain metrics as appropriate.
Technical Writing and Review:
- Prepare, revise, and archive technical documents such as area rationales, templates, SOPs, equipment procedures, risk assessments, and contamination control strategies.
- Ensure zero instances of data falsification or data integrity issues.
- Generate and report metrics for Sterile Ops led processes.
Safety and Quality:
- Inspect work area for safety regulations and recommend improvements.
- Implement safety, quality, and business improvements.
- Participate in GMP and safety self-inspection activities.
Communication and Collaboration:
- Communicate proactively regarding the status of critical compliance systems and problem resolution.
- Lead by example, working collaboratively and embracing our company’s Code of Conduct.
Support and Training:
- Provide technical support and act as a Subject Matter Expert on GQP topics.
Continuous Improvement:
- Leverage continuous improvement activities to support adherence with industry regulations, Global Quality Policies, and business procedures.
- Lead strategies to improve the qualities and efficiencies of Sterile Ops processes and systems.
- Maintain a strong understanding of current technologies and professional concepts.
Additional Responsibilities:
- Apply aseptic manufacturing principles to implement new technologies/processes.
- Apply available tools to support ongoing adherence to industry regulations and data integrity principles.
- Analyze and resolve diverse issues promptly, advancing when needed.
- Schedule and plan work to meet priorities, setting specific daily and weekly goals.
- Perform administrative tasks such as procedure and template revision, records filing, and archiving.
- Demonstrate computer proficiency, including Word and Outlook.
- Maintain good hygiene and hand-washing practices.
- Occasionally work overtime as needed.
- Be a committed team player, accepting a team-based culture.
- Identify business risks for management consideration.
Education:
- Bachelor’s degree in Chemistry, Chemical Engineering, Pharmaceutical Sciences, or a related field.
- Minimum of 2+ years of experience providing the knowledge and skills to perform the job.
- Preferred understanding of GMP manufacturing.
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