Quality Inspector - 3rd shift
On-siteSellersville, Pennsylvania, United States
Job Summary
Issue batch records aligned with production schedules, perform potency calculations, and conduct line clearance assessments verifying documentation and equipment status. Review Environmental Monitoring data, BMS alarms, and water system releases for compliance, escalating critical issues to management. Execute raw material sampling, AQL inspections, and batch reconciliations while reviewing logs to ensure adherence to GMP, GDP, and Data Integrity standards. Prepare batch records for first release, approve calibration activities, and draft or revise Quality Assurance SOPs and deviation reports. Complete assigned training on SOPs and job-related tasks. This third shift position operates from 10pm to 7am.
Required Qualifications
- Bachelor of Science
- 3 years of experience in pharmaceutical quality assurance, regulatory affairs, or GMP auditing
- In-depth knowledge of GMP, GDP, GLP, and relevant international regulations (FDA, EMA)
- Proficiency in MS Office and quality management systems (QMS)
- Ability to travel to facilities for inspections (as required)
Desired Qualifications
- Prior experience in providing on-the-floor quality oversight and conducting inspections or working in a regulated pharmaceutical environment
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