Quality Affairs – Technical Writer to create QA/QC Plans. The position is creating new or revising, editing and rewriting existing technical documents that establish how client QA program operates. The incumbent will take the lead in generating exceptional documents (e.g., quality events, out-of-specification reports, risk assessment, CAPA) to support the ongoing operations of the QA unit. The incumbent will understand QA analyses, practices, and the data that they generate and be able to compile data in an orderly and presentable fashion. They will write necessary publications, presentations, and other venues to clearly communicate the investigational findings and technical developments of the activities.
Generate controlled procedures from existing templates:
1. Quality Event Records (including deviation, planned deviation and product complaint investigations).
2. Out of Specification (OOS) investigations for internal and external analyses.
3. Risk Assessments.
5. Change Control documents.
6. Standard Operating Procedures (SOPs).
7. Audit reports.
8. Environmental Monitoring (EM) evaluation reports.
9. Master production batch records.
10. Master product specifications and Laboratory Test methods.
11. Qualification Protocols.
12. Stability Protocols, Interim Stability Reports and Final Stability Reports for products.
13. Memoranda of various sorts.
14. Other duties, as assigned.
Required Knowledge, Skills, and Abilities:
1. Must have technical experience writing and assessing Deviations, Investigations, Complaints and Out of Specifications.
2. Previous experience with CAPA programs, documentation, and metrics is required.
3. Excellent English writing, spelling, punctuation, and grammar skills.
4. Strong knowledge and understanding of US and international cGMPs, ICH, and other regulations applicable to clinical manufacturing.
5. Be able to interpret complex data and draw valid conclusions.
6. Be proficient in the use of spreadsheets, databases, presentation, and word processing software. Basic Microsoft Office proficiency is expected.
7. Strong interpersonal skills and ability to work and effectively communicate with cross-functional teams.
8. Be self-motivated, work well independently and as a team player and re-prioritize workload as required.
9. On rotating basis, be available to respond to off-hour emergency telephone calls from temperature monitoring software.