QA Specialist II

About the role

This is an onsite role. Specific Job Responsibilities:

Responsibilities

• Performs a wide variety of activities to ensure compliance with applicable regulatory requirements.
• Participates in developing Standard Operating Procedures (SOPs) to ensure quality objectives are met.
• Maintains routine programs and processes to ensure high quality products and compliance with current Good Manufacturing Practices (GMPs) and Good Laboratory Practices (GLPs).
• Reviews manufacturing, environmental monitoring and quality control data for in-process and finished products.
• 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 participate in the writing of annual product reviews and the development of training programs regarding all aspects of producing quality products.
• 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 checkpoints for new products and processes.

Requirements

Knowledge:

• Demonstrates working knowledge of current Good Manufacturing Practices (GMPs) and/or Good Laboratory Practices (GLPs).
• Demonstrates working knowledge of quality assurance systems, methods and procedures.
• Demonstrates knowledge of FDA / EMEA standards and quality systems.
• Demonstrates basic 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 good verbal, written, and interpersonal communication skills.
• Demonstrates proficiency in Microsoft Office applications.

Qualifications

• 4+ years of relevant experience in a GMP environment related field and a BS. OR 2 + years of relevant experience in a GMP environment related field and a MS.
• Prior Experience In Pharmaceutical Industry Is Preferred.

Skills

Not specified.

Benefits

The salary range for this position is: $92,820.00 - $120,120.00. Gilead considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. These considerations mean actual compensation will vary.

Pay

$92,820.00 - $120,120.00

Schedule

Not specified.