Hiring company: Gilead
QA Specialist II - Development and Commercial OSD QA
Gilead Sciences, Inc. is a research-based biopharmaceutical company founded in 1987. Together we deliver life-saving therapies to patients in need. With the commitment and drive you bring to the workplace every day, you will be part of a team that is changing the world and helping millions of people live healthier, more fulfilling lives. Our worldwide staff is a close community where you can see the tangible results of your contributions, where every individual matters, and everyone has a chance to enhance their skills through ongoing development. Our scientific focus has resulted in marketed products that are benefiting hundreds of thousands of people, a pipeline of strong late-stage drug candidates, and unmatched patient access programs to ensure medications are available to those who could otherwise not afford them. By joining Gilead, you will further our mission to address unmet medical needs and improve life by advancing the care of patients with life-threatening diseases.
Working in Quality Assurance at Gilead:
Quality Assurance delivers on Gilead’s commitment to bring life-changing therapies to patients through the robust QA processes and systems. Our approach is agile, innovative and collaborative and our teams are genuinely committed to the rapid delivery of safe life changing therapies. As part of the broader Pharmaceutical Development & Manufacturing (PDM) team you will be part of a team that is changing the world and helping millions of people live healthier, more fulfilling lives.
Essential Duties and Job Functions:
· Participates in developing Standard Operating Procedures (SOPs) to ensure quality objectives are met.
· Review and approve master batch records, labels, specifications and other pre-production documents for Clinical Drug Product in compliance with FDA and international health agency requirements.
· Performs a wide variety of activities to ensure compliance with applicable regulatory requirements.
· 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.
· Review and approve executed batch records, all other post-production documents and disposition of the lot.
· 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.
· Normally receives very little instruction on routine work, general instructions on new assignments.
Knowledge, Experience and Skills:
· 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 working knowledge of requirements for reviewing and approving production documentation.
· Knowledge and understanding 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.
· Knowledge of Risk Management principals and Risk based Quality system approaches.
· Demonstrates audit and investigational skills, and report writing skills.
· Strong verbal, written, and interpersonal communication skills.
· Biologics or Pharmaceutical industry experience is preferred.
Basic Qualifications:
· Bachelor’s degree and 4+ years of relevant experience in a GMP environment OR 2 + years of relevant experience and a MS.
For jobs in the United States:
As an equal opportunity employer, Gilead Sciences Inc. is committed to a diverse workforce. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, gender, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job related characteristics or other prohibited grounds specified in applicable federal, state and local laws. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact careers@gilead.com for assistance.
Following extensive monitoring, research, consideration of business implications and advice from internal and external experts, Gilead has made the decision to require all U.S. employees and contractors to receive the COVID-19 vaccines as a condition of employment. “Full vaccination” is defined as two weeks after both doses of a two-dose vaccine or two weeks since a single-dose vaccine has been administered. Anyone unable to be vaccinated, either because of a sincerely held religious belief or a medical condition or disability that prevents them from being vaccinated, can request a reasonable accommodation.
For more information about equal employment opportunity protections, please view the ‘EEO is the Law’ poster.
NOTICE: EMPLOYEE POLYGRAPH PROTECTION ACT
YOUR RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE ACT
PAY TRANSPARENCY NONDISCRIMINATION PROVISION
Our environment respects individual differences and recognizes each employee as an integral member of our company. Our workforce reflects these values and celebrates the individuals who make up our growing team.
Gilead provides a work environment free of harassment and prohibited conduct. We promote and support individual differences and diversity of thoughts and opinion.
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