Quality Inspector - 1st shift
On-siteSellersville, Pennsylvania, United States
Sellersville, Pennsylvania, United StatesOn-siteFull TimeEnterprise
Full TimeEnterprise
Job Summary
Issue batch records aligned with production schedules and perform potency calculations. Conduct line clearance assessments, verify equipment status, and review Environmental Monitoring data for regulatory compliance. Perform raw material sampling, AQL inspection, and batch record reconciliation. Escalate critical BMS alarms to management and approve calibration activities in ProCal. Draft, revise, and review Quality Assurance SOPs and deviation reports to ensure regulatory alignment. Complete assigned training on SOPs and stay current with industry trends and regulatory updates.
Required Qualifications
- Bachelor of Science
- 1-3 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)
- Strong analytical, attention to detail investigative, and problem-solving skills
- Excellent communication (written and verbal) and interpersonal skills
- 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 preferred
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