Kaztronix
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Technical Writer
Billerica, MA US
Posted: 11/21/2022
2022-11-21
2023-04-29
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.
Education and Requirements:
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