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Miles
Km80.5

QA Supervisor (Pharmaceuticals)

Lab Support, A Division Of On Assignment

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Location: Irvine, CA Posted Date: 4/29/2013 Position Type: Full time Job Code: CM 0002 Required Education: High school or equivalent

Description

Large, world renowned pharmaceutical company with a great reputation within the industry is seeking a Quality Assurance Supervisor.

The individual will oversee QA activity while maintaining ongoing communication with all Manufacturing Departments and will support QA Management on additional assignments and projects related to process improvement. The individual will have 2-6 direct reports.

Duties include:
• Provide department support of production (eg. Component prep, compounding, filing, packaging inspection) and in facility efforts, product related technical issues and qualification of new components. Assist in / perform lot specific investigations for management review.
• Oversee daily activities of QA technicians and perform timely review of their performance evaluations
• Oversee the manufacturing facilities regarding cGMP. Develop Action plans to improve the support of production.
• Perform and/or guide subordinates to perform QA department self-audits and develop action plans
• Review and approve filling/headspace paperwork and address manufacture variances from a Quality perspective
• Perform timely review of appropriate Production SOPs, validation reports, CSCRs, and QA Protocols
• Perform additional tasks as assigned by department management
• Oversee QA documentation system and audit proper utilization of forms, specs, and Standard Operating Procedures (SOPs)

Primary Outcomes
• Communicates Effectively - Demonstrates effective communication at all levels of the organization and across functions. Utilizes good listening skills to understand the words of others, ask questions to clarify and actively acknowledge key points
• Relationship Builder – Successfully builds productive, trusting, respectful relationships at all levels in the department
• Effective Conflict Resolution Skills – Effectively uses tact and diplomacy to resolve differences and conflicts within the organization. Promotes company values and goals as part of issue resolution.
• Continuous Improvement Focus - Contributes to process improvements for both Quality Assurance and general Manufacturing.

Requirements

• 4-year degree in Science or Life Science field, or equivalent relevant work experience; Advanced degree in Science or Life Science field, or equivalent relevant work experience preferred
• 3 years of pharmaceutical or related work experience; 3+ years in Manufacturing and Quality Assurance relating to parenteral pharmaceuticals preferred
• Knowledge in Root Cause Analysis, SPC, LIMS, and Leadership Training preferred
• Ability to work with computers and data based systems.
• Ability to write and understand technical information.
• Ability to understand data processed by typical manufacturing equipment
• Ability to schedule employees with a dynamic Manufacturing schedule.
• Ability to maintain a relatively consistent attitude toward work and toward other people
• Ability to communicate effectively toward direct reports, management, and senior management.
• Ability to present data and investigational information in front of small to medium size groups
• Ability to work independantly with minimal supervision.
• Ability to make quality decisions with minimal supervision
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