Job Description:
Client is looking for a very engaged, and collaborative QA Tech Writer contractor who prides themselves on being a self-starter. Looking for this person to have a very active presence. Engage with SMEs and not wait on things to be sent to them. Looking to really take the initiative and be visible getting input from cross functional groups and take the proactive stance to drive the production of these documents. Must have technical knowledge of drug product / drug substance manufacturing, vendor management/suppliers, knowing how to evaluate risk and work with external CMO’s. Work will entail writing GMP procedures for the QA team. Writing Work instructions, policies, and facilitate the review and approval of these SOPs, Instructions, policies in their Veeva QualityDocs system: Additionally, ensuring documents are consistent with internal style guidelines for format, clarity, flow, organization, and readability. Manage work independently with support from cross functional teams in Manufacturing, Formulation, QA Ops, Quality Systems, Compliance or Clinical QA to establish comprehensive implementation plans for document revisions and associated change requests. Must be able to effectively facilitate opposing viewpoints as applicable and provide recommendations as needed. Again, looking for outgoing technical writer who can step in and drive this work forward.
Skills:
- Quality
- SOP
- Write/Author
- Veeva
- Drive/Lead
Education:
- B.S. Degree in relevant field required.
CA: QA Technical Writer (237665)
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