Qa Specialist Iii Jobs

At Gilead we believe every employee deserves a great leader. As a people leader now or in the future, we expect that you will model and create an environment of inclusion, be intentionally focused on the hiring, development, growth and retention of talent, and empower teams to align and achieve goals.

• Develops solutions to more complex problems and identifies deviations from accepted practice and evaluates impact assessment as required.
• Works directly with contract manufacturers and alliance partners to manage quality related issues with minimal supervision.
• Participates in developing Standard Operating Procedures (SOPs) to ensure quality objectives are met.
• Conducts or serves as a lead/coordinator of deviations, laboratory investigations, and corrective and preventive action (CAPA) recommendations. May represent QA on Material Review Boards, escalations, and will need to communicate critical events in a timely manner.
• Reviews executed production batch records, environmental monitoring data (as required), analytical data, and associated documentation, including any deviation and investigation reports related to lot release of Gilead product in support of product disposition.
• Reviews and approves master batch records, labels, specifications and other pre-production documents for Gilead product in compliance with FDA and international health agency requirements.
• Writes, revises, and reviews standard operating procedures
• Normally receives very little instruction on routine work, general instructions on new assignments.
• Assists in compliance audits as required.
• Maintains electronic records (IQS) and paper archives (lot history records, reports, and logbooks) as needed
• Performs a wide variety of activities to ensure compliance with applicable regulatory requirements.
• Leads laboratory quality activities for analytical operations, quality control, and contract labs across clinical and commercial partners.
• Interacts with key stakeholders such as Formulation and Process Development, and Regulatory Affairs to ensure that Gilead products are manufactured in accordance with established procedures, cGMPs, and appropriate regulations.
• Assists in departmental planning activities to ensure that deliverables are provided according to project timelines
• Maintains programs and processes to ensure high quality products and compliance with current Good Manufacturing Practices (GMPs) and Good Laboratory Practices GLPs).
• Reviews and approves method validation/method transfer activities from Phase 1 through commercial.
• Review and approve stability protocols and reports as well as analytical and stability data in regulatory findings and data generated by and for Gilead Sciences.

• Ability to lead a project team
• Must be a critical thinker and can exercise sound judgment in compliance with defined procedures and current industry practices and must recognize deviations from accepted practice
• An accountable team player who is detail and quality oriented with solid understanding of quality assurance principles, systems, and procedures
• Ability to act as a mentor to junior staff
• Self-starter, able to work independently
• Strong working knowledge of Quality Systems and cGMP standards
• Strong problem solving, leadership, and negotiation skills
• Excellent attitude with strong verbal, written, and interpersonal communication skills
• Experience in an outsourced pharmaceutical manufacturing model and working with CMOs to drive improvement
• Background in analytical method validation and method transfer activities
• Strong background in laboratory investigations, deviations, and associated CAPAs
• Experience in pharmaceutical manufacturing and analytical testing
• Able to travel infrequently (less than 10%)
• Ability to work on complex issues where analysis requires an in-depth assessment, consideration of many variables, and potential consequences

• Reviews routine manufacturing, environmental monitoring and quality control data for in-process and finished products.
• May facilitate external audits/inspection processes, supporting implementation of corrective actions as agreed.
• Maintains programs and processes to ensure high quality products and compliance with current Good Manufacturing Practices (GMPs) and Good Laboratory Practices (GLPs).
• May assist with compliance audits as required
• Participates in the writing of annual product reviews.
• 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.
• Participates in developing Standard Operating Procedures to ensure quality objectives are met.
• Interfaces with contract manufacturers to address documentation and compliance issues.
• Works with Research and Development during new product start-ups and identifies routine checkpoints for new products and processes.
• Normally receives no instruction on routine work, general instructions on new assignments.
• Writes and/or implements changes to controlled documents (e.g., SOPs, specifications, methods, etc.) as needed.
• May conduct or serve as a lead/coordinator of investigations and corrective and preventive action (CAPA) recommendations related to manufactured products.
• Performs a wide variety of activities to ensure compliance with applicable regulatory requirements.
• Develops solutions to more complex problems and identifies deviations from accepted practice and evaluates impact assessment as required.

• 4+ years of relevant experience and a MS.
• 6+ years of relevant experience in a GMP environment related field and a BS or BA.

• Demonstrates strong knowledge of six sigma, LEAN and root cause analysis tools used for identifying and correcting deviations
• Demonstrates strong verbal, technical writing and interpersonal skills.
• Demonstrates proficiency in application of QA principles, concepts, industry practices, and standards.
• Demonstrates audit and investigation skills, and report writing skills.
• Demonstrates proficiency in Good Manufacturing Practices (GMPs) and/or Good Laboratory Practices (GLPs).
• Demonstrates proficiency in Microsoft Office applications.
• Demonstrates thorough knowledge of FDA / EMEA standards and quality systems, and the interface with other functions like manufacturing, distribution and maintenance.
• Prior experience in pharmaceutical industry is preferred.

The salary range for this position is: $112,030.00 - $144,980.00. Gilead considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. These considerations mean actual compensation will vary. This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary based on role), paid time off, and a benefits package. Benefits include company-sponsored medical, dental, vision, and life insurance plans*.

• Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans.