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Gilead

QA Specialist III

For Current Gilead Employees and Contractors:

Please log onto your Internal Career Site to apply for this job.

Job Description

Knowledge:
Demonstrates proficiency in Good Manufacturing Practices (GMPs) and/or Good Laboratory Practices (GLPs).
Demonstrates proficiency in application of QA principles, concepts, industry practices, and standards.
Demonstrates thorough knowledge of FDA / EMEA standards and quality systems, and the interface with other functions like manufacturing, distribution and maintenance.
Demonstrates strong knowledge of six sigma, LEAN and root cause analysis tools used for identifying and correcting deviations
Demonstrates audit and investigation skills, and report writing skills.
Demonstrates strong verbal, technical writing and interpersonal skills.
Demonstrates proficiency in Microsoft Office applications.
Specific Education & Experience Requirements:
6+ years of relevant experience in a GMP environment related field and a BS or BA.
4+ years of relevant experience and a MS.
Prior experience in pharmaceutical industry is preferred.
Specific Job Responsibilities:
Performs a wide variety of activities to ensure compliance with applicable regulatory requirements.
Participates in developing Standard Operating Procedures to ensure quality objectives are met.
Maintains programs and processes to ensure high quality products and compliance with current Good Manufacturing Practices (GMPs) and Good Laboratory Practices (GLPs).
Reviews routine manufacturing, environmental monitoring and quality control data for in-process and finished products.
Develops solutions to more complex problems and identifies deviations from accepted practice and evaluates impact assessment as required.
Works directly with operating entities to ensure that inspections, statistical process control analyses and audits are conducted on a continuing basis as specified to enforce requirements and meet specifications.
May facilitate external audits/inspection processes, supporting implementation of corrective actions as agreed.
Participates in the writing of annual product reviews.
May conduct or serve as a lead/coordinator of investigations and corrective and preventive action (CAPA) recommendations related to manufactured products.
Works with Research and Development during new product start-ups, and identifies routine checkpoints for new products and processes.
May assist with compliance audits as required.
Interfaces with contract manufacturers to address documentation and compliance issues.
Writes and/or implements changes to controlled documents (e.g., SOPs, specifications, methods, etc.) as needed.
Normally receives no instruction on routine work, general instructions on new assignments.


For Current Gilead Employees and Contractors:

Please log onto your Internal Career Site to apply for this job.

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