This position is open for a Technical Writer with a minimum of 5 years of experience in the pharmaceutical industry. The candidate must have solid GMP and regulatory experience and will be responsible for providing support in assessment, improvement, standardization and/or creation of SOPs.
Duties and Responsibilities
Skills and Specifications
- SOPs: Consolidate redundant information, change, improve and create new ones.
- Work with cross site personnel in teams to understand/make recommendation on network SOP’s.
- Participate in meetings to understand procedures, resolve problems, address issues and develop new strategies.
- Gathering data and compile documentation.
- Participate in brainstorming sessions to identify root causes of gaps/observations and corrective actions.
- Lead/support requirements for compiling documentation for evidence binders. Manage multiple priorities.
- Communicate with the staff and management on ways of implementing plans and recommendations.
- Must possess a solid understanding of FDA Validation guidelines and industry best practice for this field; and be able to implement Validation standards on a daily basis.
- Good problem solvers.
- Be able to sense needs when they arise.
- Be organized.
- Keep an eye for detail.
- Willing to work overtime including weekend depending on the nature of work available.
- Able to work with minimum or no supervision
- Strong interpersonal skills and must work in a team
- Fully Bilingual (English and Spanish)
Bachelors of Science in Science or Engineering.
Ultimate Solutions Corp is an Equal Opportunity Employer.