QA Manager
Open Scientific
- Deer Park, Texas, United States
- Deer Park, Texas, United States
Über
Pay: $70,000 to $80,000
Responsibilities & Duties
Responsible for all quality systems for label manufacturer of clinical trials and investigational drug products.
Responsible for a staff of 22 individuals, including 3 Managers and 2 supervisors.
Develop, write, revise and approve all SOPs.
Solely responsible for customer audits, including audit responses.
Instituted company-wide calibration program, effectiveness training, mock recalls, AQL statistical sampling plans, line clearance methods and specifications for components.
Developed code system for customer complaints, investigations, utilized in trending analysis.
Developed training matrices for all employees.
Responsible for cGMP and SOP training programs.
Write and execute validation protocols - Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification on various equipment.
Complete customer Quality Agreements, Technical Agreements and questionnaires.
Revised and enhanced preventative maintenance program, ensuring overall compliance.
Maintain Material Safety Data Sheet (MSDS) manuals, facility pest control and emergency lighting programs.
Additional Information All your information will be kept confidential according to EEO guidelines.
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Sprachkenntnisse
- English
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