RSO Specialist II

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

Thermo Fisher Scientific's Viral Vector Services (WS) Is a rapidly growing, multifaceted gene therapy contract development and manufacturing organization (CDMO) that Is seeking sharp individuals to bring the highest quality processes, products and testing to our clients. Our employees are committed to making a difference in our organization, for our client partners and the patients we serve. We are looking for top talent with proven proficiencies and strong character to Join our team and help lead our organization Into the future.

Plainville. MA (5 Commerce Boulevard): In this role you will help support and implement the large capital facility project through the construction of a new pioneering commercial manufacturing facility.

How will you make an impact?

The Specialist is an associate with a minimal level of expertise and experience with general biopharmaceutical manufacturing equipment, principles and processes and has a good understanding of current GMP and safety standards. The Specialist collaborates with subject matter professionals and technical specialists to plan, develop, author, edit format illustrate, update, and build new standard operating procedures and other related documentation such as PBRs, logbooks, Job aids and technical reports in support of the cGMP Manufacturing facility. Responsibilities include maintaining established documentation design and quality standards, using performance tools (Human Performance) and leading documentation workflows to meet departmental needs.

Additional responsibilities may include administrative duties to manage and process-controlled documents for the manufacturing processes.

What will you do?

• Collaborates with area SMEs or technical specialist to build or revise existing procedures or documents for use In the manufacturing processes.
• Acquires and verifies accuracy of technical details, manages documentation workflows and schedules and proofreads drafts for adherence to established document design and quality standards.
• Performs administrative duties related to managing controlled document life cycles from issuance to Manufacturing through archival with Quality Assurance.
• Responsibilities may include maintaining the GMP manual of Standard Operating Procedures and management of logbooks for the manufacturing operations.
• Provides 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.
• Participates 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 3 years related experience
  • 2 years industry related experience with an Associate's Degree
  • 0 years Industry related experience with a Bachelor's Degree
• Strong interpersonal and communications skills written and oral.
• Must be skilled In the use of a personal computer and related software applications.
• Must have strong Interpersonal and communication skills and the ability to work effectively with a wide range of constituencies In diverse areas.
• Must be skilled In meetings and interviews to eliciting technical details from subject matter specialists.
• Must be able to provide effective written or verbal communication to peers, senior associates, and area management within their operational group.
• Must be able to develop logical structure for technical documents, content and illustrations
• Must be detail oriented while proofreading documents.
• Must be able to recognize, understand and respond to situations requiring further evaluation and report these events (process, safety, personnel, etc.) to senior specialists or area management.
• Must be able to understand operational documents for GMP compliance, accuracy and completeness.
• Gown aseptically and/or sterile gown as needed.

Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us (https://jobs.thermofisher.com/global/en/5-reasons-to-work-at-thermo-fisher-scientific). A one team of 100,000 colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory at Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.

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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.

Salary : $40 - $0