As part of the Thermo Fisher Scientific team, you'll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner, and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world's toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer.
Location/Division Specific Information
At Viral Vector Services 0/VS) a division of Thermo Fisher Scientific we deliver, from process development through commercial supply, we offer the expertise and resources vital to help clients deliver innovative gene therapies. Placed in the forefront of our leading and groundbreaking Cell and Gene Therapy business enabling clients to cure genetic, rare, and otherwise untreatable diseases.
Discover Impactful Work:
In the RSO II Specialist role, they will have the basic knowledge and experience in biopharmaceutical manufacturing equipment, principles, and processes. They work with experts to create and update procedures and other documentation for the cGMP Manufacturing facility. They will use strong interpersonal, communication and teamwork skills to efficiently implement manufacturing documentation including master production records, standard operating procedures, work instructions, job aids, and learning documents.
A Day in the Life:
Collaborate with area SMEs or technical specialists to build or revise existing procedures or documents for use in manufacturing.
Acquire and verify the accuracy of technical details, lead documentation workflows and schedules, and proofread drafts for adherence to established document design and quality standards.
Perform administrative duties related to leading controlled document life cycles from issuance to Manufacturing through archival with Quality Assurance.
Responsibilities may include maintaining the GMP manual of SOPs and management of logbooks for the manufacturing operations.
Provide training to junior associates on established writing standards for documentation design and quality.
Training provided may also include company policies, programs, and procedures commensurate with their experience as a qualified trainer.
Participate in initiatives to support innovation and continuous improvement activities and improved compliance with quality procedures, policies, and regulations.
How will you get there?
Minimum High School Diploma required with 5+ years of related experience.
An Associate's Degree or equivalent experience with 3-4 years of industry-related experience.
1-2 years of industry-related experience with a Bachelor's Degree or equivalent experience.
Strong interpersonal and communications skills; written and oral.
Must have strong interpersonal and communication skills and the ability to work efficiently with a wide range of constituencies in diverse areas.
Must be skilled in meetings and interviews to elicit technical details from subject matter specialists.
Provide effective written or verbal communication to peers, senior associates, and area management within their operational group.
Develop logical structures for technical documents, content, and illustrations.
Required to be diligent when proofreading documents.
Recognize, understand, and respond to situations requiring further evaluation and report these events (process, safety personnel, etc.) to senior specialists or area management.
Understand operational documents for GMP compliance, accuracy, and completeness.
Gown aseptically and/or sterile gown as needed.
Technical and operational SME (Subject Matter Experts) in multiple systems (e.g., upstream, downstream)
Support and coordinate critical and non-routine operations.
Join our team of 100,000+ colleagues who share common values and work together to make the world healthier, cleaner, and safer! Experience the benefits of working at Thermo Fisher Scientific and #StartYourStory with us!
