The Specialist 1 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 1 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.
- 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.
Knowledge, Skill and Requirements:
- 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.
EDUCATION AND QUALIFICATIONS:
- 1-3 years' industry related experience with a Bachelor's Degree
- 2-4 years' industry related experience with an Associate's Degree/Certificate Program
- 3-5 years' industry related experience with a high school diploma
- Strong interpersonal and communications skills; written and oral.
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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.
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