Job description
The Technical Writer, Technical Operations department is responsible for providing the coordination and completion of technical documentation such as Batch Records, SOP, Change Controls and Risk Assessments. In addition, this role is responsible for tracking the documents in Master Control. You are a recognized subject matter expert as a technical writer with experience in the general cGMP environment for pharmaceutical drug products. The expectation of the role is to support R&D Scientists and Technology Transfer Engineers in their efforts to conduct product development experiments and new product/process introductions.
Responsibilities
- Revision/creation of SOP's Master Batch Records, Summary reports, Protocols, etc. based on technical information provided by internal SME's (process flow diagrams, client batch records/protocols, data summaries etc…)
- Tracking assigned Change Controls, CAPA's, Issue Reviews etc. open tasks and collaborate with internal and external stakeholders to manage due dates and required input
- Evaluation of client provided documents, internal/external reports and feedback to properly inform internal document creation and revision
- Work closely with the Quality Assurance team to maintain current templates for documents based on documentation and compliance best practices
- Support continuous improvement efforts to revise all document templates as required
- Support issuance of change controls in Master Control e-QMS for introduction of new processes and changes to existing processes
- Work in conjunction with area owners to ensure document design meets internal and external expectations
- Management of multiple projects and concurrent timelines while adhering to standard timelines, and escalating actions appropriately for resolution in a timely manner
- Support active project execution as required in support of R&D Scientists and Technology Transfer Engineers
Requirements
- 2+ years work experience in a pharmaceutical or life science related field
- Proficiency with technical writing in cGMP or FDA regulated manufacturing environment
- Bachelor's degree in science, technology, or related field preferred.
- Ability to work in a fast-paced environment and manage multiple projects and objectives for on-time event closure
- Understanding of aseptic manufacturing processes
- Able to be proactive, action-oriented, and adapt to change
- Able to identify and flag risks in a timely manner to keep deliverables on track
- Strong written and verbal communication skills
- Ability to read and comprehend complex subjects related to pharmaceutical manufacturing
- Ability to document complex ideas in way that others can easily understand
- Strong typing and computer skills, including efficiency using Microsoft Office Suite (Word, Excel, PowerPoint), and familiarity with cGMP quality systems
- Ability to understand and apply GMP regulations as they relate to pharmaceutical manufacturing
Physical / Safety Requirements
- Duties will require work on multiple shifts, including nights and weekends on occasion
- Ability to wear protective gear (e.g., gowns, gloves, face masks)required to enter our cleanrooms and production spaces.
- Ability to stand for long hours at a time to observe production as needed.
