Planet Pharma is hiring : Technical Editor II in Hillsboro

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Job Description

This position is supporting analytical transfer documentation in the Analytical Development and Quality Control department. This position supports the Analytical Development team in the cell and gene therapy division, authoring and reviewing documents such as method validation protocols, reports, test methods, and SOPs, while ensuring GMP standards are met.

Job Description

This position is supporting analytical transfer documentation in the Analytical Development and Quality Control department. This position supports the Analytical Development team in the cell and gene therapy division, authoring and reviewing documents such as method validation protocols, reports, test methods, and SOPs, while ensuring GMP standards are met.

You are responsible for working closely with relevant stakeholders as well as cross-site SMEs to draft, review and approve technical documents.

Job Duties / Responsibilities

• Author and edit a wide range of technical documents, including but not limited to :
• Standard Operating Procedures (SOPs)
• Validation protocols and reports for analytical methods
• Test methods and work instructions
• Change control records
• Ensure all documentation adheres to strict regulatory guidelines (e.g., FDA, EMA, ICH, cGMP) company policies, and quality standards.
• Translate complex scientific and technical information into clear, concise, and user-friendly content for various audiences, including scientists, technicians, and quality assurance personnel.
• Manage the document lifecycle, including drafting, review cycles, approval, revision, and archival within an electronic document management system (EDMS).
• Collaborate closely with Subject Matter Experts (SMEs), such as scientists and lab managers, to gather information and ensure the technical accuracy of all content.
• Facilitate document review meetings and incorporate feedback from stakeholders and subject matter experts.
• Ensure a consistent and predictable approach to documentation, maintaining a unified style, terminology, and format across all documents.
• Review documents for scientific and technical accuracy, clarity, and adherence to Good Manufacturing Practice (GMP) standards.

Job Qualifications

You Will Stand Out If You Have

Pay Rate Range : 45-57 / hr depending on experience

The Planet Group of Companies is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.

Seniority level

Seniority level

Not Applicable

Employment type

Employment type

Full-time

Job function

Job function

Marketing, Public Relations, and Writing / Editing

Industries

Staffing and Recruiting

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