Thermo Fisher Scientific Specialist II, Manufacturing Compliance in Cambridge, Massachusetts
Job Title: Compliance Specialist II, Manufacturing
Requisition ID: 168991BR
When you're part of the team at Thermo Fisher Scientific, you'll do important work. Surrounded by collaborative colleagues, you'll have the support and opportunities that only a global leader can give you. Our respected, growing organization has an exceptional strategy for the near term and beyond. Take your place on our strong team and help us make significant contributions to the world.
Location/Division Specific Information
How will you make an impact?
The 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 years' industry related experience with a Bachelor's Degree.
4 years' industry related experience with an Associate's Degree/Certificate Program.
6 years' industry related experience with a high school diploma.
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.
Strong interpersonal and communications skills; written and oral.
At Thermo Fisher Scientific, each one of our 75,000 extraordinary minds has a unique story to tell. Join us and contribute to our singular mission-enabling our customers to make the world healthier, cleaner and safer.
Apply today! http://jobs.thermofisher.com
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.
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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