Technical Writer
On-siteAllentown, Pennsylvania, United States
Job Summary
Conduct process and vendor audits, review computer system validation data, and evaluate analytical reports for completeness and accuracy. Represent the department in client and regulatory inspections, lead corrective action development, and manage document setup and filing. Participate in inter-departmental meetings to contribute to policy-making decisions and provide training for laboratory staff. Verify sample identification, inventory submissions, and batch record documentation while potentially leading risk assessments and mentoring junior team members. Requires 5+ years of QA experience and Bachelor's degree. Standard office hours with potential exposure to biological fluids and electrical equipment.
Required Qualifications
- Bachelor's degree or equivalent and relevant formal academic / vocational qualification
- Previous lab or QA experience that provides the knowledge, skills, and abilities to perform the job (comparable to 5+ years)
- comprehensive expertise to the department covering one or more specialized quality management areas assuring all systems, processes and their outcomes comply with applicable international and national regulations
- GxP expertise
- Trackwise experience preferred
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