We have a current opportunity for a Technical Writer on a 6-month contract basis with an opportunity to extend. The position will be based in Waltham, MA, and requires candidates to be on-site at least 4 days a week. We are only able to place candidates on a W2 basis. For further information about this position please apply.
Responsibilities
- Collaborate with manufacturing, plant services, engineering to ensure timely documentation, root cause analysis, and QA closure of Stage II OOS investigations and OOT investigations
- Work directly on technical investigations relating to product quality complaints
- Participate in other quality investigations and risk assessments as requested to perform review of documents, processes, testing, etc.
- Author/revise standard operating procedures (SOPs) and batch records, as required
- Other duties as assigned
Education
- BS in chemistry or related scientific field, or equivalent education and experience
- Superior internal and external customer service/people skills
- Ability to manage multiple responsibilities and projects in a fast paced environment, while performing in an efficient manner
Experience
- Minimum 2-4 years related experience in a pharmaceutical manufacturing environment
- Working knowledge of cGMPs
- Experience with the manufacture and testing of radiopharmaceuticals is strongly preferred
- Strong familiarity with regulatory / compliance environment (cGMP, GLP) associated with parenteral drug manufacture
- Strong working knowledge of MS Office software
