Technical Writer

Billerica, MA

Posted: 11/21/2022 Industry: Scientific Job Number: 22-01349

Job Description

Job Description:
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.
  • 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

Education and Requirements:
  • 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
  • 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

Meet Your Recruiter

Alyssa Darden

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