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Miles
Km80.5

Senior QA Specialist

ForSight VISION5, Inc.

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Location: Menlo Park, CA Posted Date: 4/11/2013 Position Type: Full time Job Code: Senior QA Specialist Required Education: Bachelors Degree Areas of Expertise Desired: Quality Assurance

Description

POSITION SUMMARY:
This position will establish and maintain quality engineering methodologies such as design control, change control, quality planning, complaint handling, auditing, CAPA and supplier management.  Provide quality engineering support/product risk management and technical problem-solving.

DUTIES AND RESPONSIBILITIES.
• Review and approval of facility, equipment and manufacturing process/change control documentation.
• Ensure that product and process changes are properly qualified prior to becoming effective. Review validation activities (IQ/OQ/PQ) including protocols and final reports related to manufacturing processes including inspection equipment and analytical test methods.
• Establish and manage the design and development process.
• Manage Product risk management file updates, risk assessments to support complaints, CAPAs, and related product risk assessments.
• Perform training to support compliance to internal procedures and external regulations.
• Develop and enhance measurement, inspection and test systems for existing products and processes. Maintain and develop quality assurance inspection and test procedures and work instructions.
• Coordinate and perform audits of both internal and external operations.  Identify compliance risks and report findings to appropriate management with recommendations for resolution.
• Design History Record/Batch record review and product release including review of analytical test data.

Requirements

• Minimum 10 years in drug delivery or combination (drug/device) products.
• BA/BS Degree in scientific discipline.
• Strong knowledge of both drug and device cGMP (21 CFR Parts 210, 211 and 820)
• Excellent written and verbal communication skills.
• Experience with analytical and statistical techniques such as DOE.
• Ability to critically evaluate and troubleshoot complex problems is essential.  Must take initiative and be solution oriented.
• Must be able to work in a team oriented, fast paced environment with multiple priorities.
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