Technical Writer/Trainer presso AVEVA DRUG DELIVERY SYSTEMS INC

Description

Job Summary:

The incumbent will provide documentation support for various Production, R&D and Technical Service functions as determined by project assignments.  The position will work closely with Production members and outside departments to coordinate and facilitate the various needs of the department.  Accomplishments will be objectively determined by the successful and timely completion of coordination and support activities, including documentation creation and implementation.  The position exists to support the ongoing creation and execution of the product pipeline for the company.

Job Responsibilities

• Responsible for creating and managing project documentation, including change control documents, raw material specification, forms, master batch records, protocols, and other documents as assigned to support Production needs.
• Responsible for coordinating raw material and API orders with the Purchasing Department as required to support project needs. 
• Responsible for assisting with the procurement and tracking of raw materials, parts, and equipment, as needed for different projects.
• Responsible for assisting in communication of general R&D and Technical Services requirements to other departments.
• Responsible for supporting or assisting with the activities relating to Production process and GMP batch preparation
• Responsible for operating in accordance with the company’s Code of Conduct and Business Ethics, and all established regulatory, compliance and safety requirements.
• Other related responsibilities as assigned by Production management.

Major Duties

• Creation of specifications for raw materials and supplies for Production projects, and collection of documents required to support raw material assessments
• Creation of Production, R&D and Technical Services documentation including Master Batch Records, Forms, Protocols, summaries, and other related documentation
• Procurement and tracking of materials, parts, equipment, and supplies supporting Production development projects
• Review and confirmation of the status of materials, parts, equipment and facilities, as needed for development projects
• Work with offsite groups to assist with the transfer of information to the Aveva site in support of Production Projects
• Assist with the preparation activities pertaining to Production process trials and GMP batch preparation, including materials requisitions, preparation of trial notebooks, and QA / Trackwise documentation.
• Work with Project Management to assist with the alignment of Production needs and deliverables within the project.

Qualifications

Education

• Bachelor’s degree from an accredited university in Biology, Chemistry, Engineering or similar field.

Knowledge, Skills and Abilities

• Strong organizational and communication skills, ability to work effectively with internal and external team members and work effectively as a team member
• Ability to track project tasks and deliverables
• Strong writing skills and ability to write clear, concise, documents of a technical nature
• General knowledge of the pharmaceutical work environment, such as GMP and safety practices
• Computer skills including MS Word, Excel, PowerPoint, and other relevant software programs

Experience

• Bachelor’s degree and minimum of two (2) to four (4) years of pharmaceutical-related experience
• High school graduate, and six (6) or more years of pharmaceutical-related experience.