Quality Assurance Technical Writer
The Quality Assurance Technical Writer will author documentation including Standard Operating Procedures (SOPs), Specifications, and Clinical Documents following current Good Manufacturing Practices (cGMP).The individual will work cross-functionally with all Wellstat departments, contract manufacturers (CMOs), and clinical sites to ensure timely completion of documentation in accordance with schedules and timelines.
- Analyze upstream and downstream processes and make recommendations for efficient and effective supporting document structure.
- Collaborate with area managers to develop and refine documentation.
- Work on assignments that are complex in nature where action and a high degree of initiative are required to resolve challenges associated with new processes and make recommendations.
- Write, review, and/or edit all types of documentation produced within a GMP environment including but not limited to:
- Raw material and finished product specifications
- Test and inspection methods
- Standard operating procedures
- Manufacturing work instructions
- Master batch records
- Qualification protocols and reports
- Track documentation deliverables and manage to timelines.
- Provide training related to new or revised documents, as needed.
- Assist in documentation audits and publish audit reports.
- Assist QA management with special projects or other duties as assigned.
- Demonstrated technical writing skills with the ability to create clear and concise written instructions and intuitive recording forms.
- Practical knowledge of FDA regulations including GMP and GDP.
- Prior evidence of successful participation on work teams where combined contribution, collaboration, and results were expected.
- Expertise with Microsoft Word, Excel, Adobe Acrobat, and PowerPoint, to perform critical job functions.
- Strong organization skills, with the ability to organize, plan, prioritize work, and manage multiple projects effectively, within agreed-upon timelines.
- Strong interpersonal skills, with the ability to positively interface with individuals at all levels of the organization.
- Strong communication skills, including written, verbal, and presentation.
- Strong team orientation, with the ability to self-start, as well as work independently.
- Strong attention to detail with the ability to perform tasks with a high degree of accuracy.
- A minimum of 5+ years’ process operations experience in a manufacturing facility subject to GMP regulations with 3+ years’ experience with technical writing.
- Experience generating quality system and operations-related documentation in a GMP environment.
- BS in a life science-related discipline is preferred; or combination of education and work experience.
During the COVID-19 pandemic, it is expected that the successful candidate will work onsite in Rockville, MD at least two days per week. Thereafter, the onsite work schedule is likely to be five days onsite.
Wellstat Management Company, LLC is an equal opportunity employer and offers an excellent salary and benefits package.