Thermo Fisher Scientific Specialist II, Manufacturing in Cambridge, Massachusetts
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.
At Viral Vector Services (VVS) a division of Thermo Fisher Scientific we deliver, from process development through commercial supply, we offer the expertise and resources necessary to help clients deliver innovative gene therapies. Placed in the forefront of our leading and cutting edge Cell and Gene Therapy business enabling clients to cure genetic, rare, and otherwise untreatable diseases.
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. Viral Vector Services is a dynamic gene and cell therapy contract development and manufacturing organization that is looking for leaders to bring the highest quality processes, products and testing to our clients. Our staff members are committed to making a difference in our organization, for our client partners and the patients we serve. We seek individuals with proven competencies and strong character to help lead our organization now and into the future.
How will you make an impact?
The Manufacturing Specialist II 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 II collaborates with subject matter experts and technical specialists to plan, develop, author, edit, format, illustrate, update, and create new standard operating procedures and other related documentation such as PBRs, logbooks, job aids and technical reports in support of the cGMP compliant Manufacturing facility. Responsibilities include maintaining established documentation design and quality standards, using performance tools (Human Performance) and managing 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 create or revise existing procedures or documents for use in the manufacturing processes.
Obtains 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 here?
2-4 years' industry related experience with a Bachelor's Degree
4-6 years' industry related experience with an Associate's Degree/Certificate Program
6-8 years' industry related experience with a high school diploma
Strong interpersonal and communications skills; written and oral.
Knowledge, Skills, Abilities
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 experts.
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.
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 .
Thermo Fisher Scientific is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, creed, religion, color, national or ethnic origin, citizenship, sex, sexual orientation, gender identity and expression, genetic information, veteran status, age or disability status.
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