QA Manager

Company Description Open Scientific provides contract staffing and direct hire recruitment services for the scientific, engineering, laboratory and manufacturing sectors.

Job Description

An ever growing company is looking for an experienced QA Manager. The ideal candidate has at least 5 years of management experience in the pharmaceutical/nutraceutical/food industry.

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.