We have a current opportunity for a Technical Writer on a 6-month contract basis on a W2. The position will be based in Billerica. For further information about this position please apply.
Location: Billerica, MA
Type: On-site, can be hybrid
Contract length: 6 months, opportunity to extend
The Technical Writer provides support in the root cause analysis and closure of OOS investigations, OOT investigations and product quality complaints; ensures compliance with current Good Manufacturing Practices (cGMP) and Quality Management System standards.
Responsibilities
- Explain technical ideas in simple language
- Meet with customer representatives to establish technical specifications
- Create user documentation for a variety of material
- Collaborate with manufacturing, plant services, engineering to ensure timely documentation, root cause analysis, and QA closure of Stage II OOS investigations and OOT investigations
- Participate in other quality investigations and risk assessments as requested to perform review of documents, processes, testing, etc.
Qualifications
- Experience in the technology industry
- BS in chemistry or related scientific field, or equivalent education and experience
- Minimum 2-4 years related experience in a pharmaceutical manufacturing environment
- Working knowledge of cGMPs
- Strong familiarity with regulatory / compliance environment (cGMP, GLP) associated with parenteral drug manufacture
- Strong working knowledge of MS Office software
- Strong written and verbal communication skills
- Ability to understand highly technical information
