Overview
QA Technical Investigation Writer (Pharma) Jobs in United States at Element Staffing Services
Title: QA Technical Investigation Writer (Pharma)
Company: Element Staffing Services
Location: United States
Element Staffing is currently hiring a Technical Investigation Writer for a pharma manufacturing client in North Carolina! This role can sit remote and is a 3-4 month contract opportunity.
Key Responsibilities:
- Investigate the quality deviations observed during raw material dispensing / manufacturing / packaging operations.
- Review GMP documents such as SOPs, Batch records, Logbooks to identify the root cause for the reported deviation using Kepner-Tregoe, Ishikawa, Fish bone, 5 Why methods.
- Partner with Technical Services, Engineering and Manufacturing team members to determine the scope, impact and risk associated with the deviations/non-conformances observed in Manufacturing and Packaging department.
- Work with QA Compliance team members to finalize investigation reports and identify necessary CAPA for the reported deviation/non-conformance in timely manner.
- Ensure timely implementation of CAPA resulting from deviations, customer complaints, Internal Audits. Monitor and ensure closure of all open deviations/non-conformances and CAPAs within defined timeframes.
- Review deviation trend to determine and propose appropriate actions needed to prevent reoccurrence of similar events.
- Review and revise GMP documents (SOPs/Work Instructions/Productions Records, etc.)
