QA Specialist III - Clinical QA Support Operations
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POST DATE 8/18/2016
END DATE 12/14/2016
Gilead Sciences, Inc
Foster City, CA
JOB DESCRIPTIONSPECIFIC RESPONSIBILITIES
With the commitment and drive you bring to the Pharmaceutical Development & Manufacturing (PDM) workplace, you will be part of a team that is changing the world and helping millions of people live healthier, more fulfilling lives. You will see the tangible results of your contributions, where every individual matters, and everyone has a chance to enhance their skills through on-going development. Our scientific focus has resulted in marketed products that are benefiting hundreds of thousands of people, a pipeline of late-stage drug candidates, and unmatched patient access programs to ensure medications are available to those who could otherwise not afford them. By joining PDM at Gilead, you will further our mission to address unmet medical needs and improve life by advancing the care of patients with life-threatening diseases.
* Responsible for daily activities and ensure continuous improvement in the area of inspection preparedness, training, EET/CAPA tracking, metric reporting, and system design, implementation, and optimization
* Lead/participate in project team to streamline Clinical QA processes and SOPs by reviewing existing workflows and identifying areas for improvement.
* Perform SOPs periodic review, write/revise SOPs and design process flowcharts
* Provide QA support for the design, implementation, integration, and continuous improvement of key software solutions (TrackWise, LIMS, EBS, and Gilead s batch disposition, business analytics, and CXO interface tools)
* Responsible for ensuring CAPA/ audit observations responses are appropriately implemented and closed in a timely manner
* Coordinate inspection and audit support for Clinical QA during internal / regulatory inspections and audits
* Review and may approve change control requests, investigations, and proposed corrective and preventative actions to ensure compliance with Gilead procedures, cGMP and all other applicable regulations
* Manage Clinical QA training requirements and curricula, OJT qualification programs, and New Employee Onboarding programs to drive improved employee qualification and training compliance
* Maintain systems for organizing, tracking, trending and reporting Deviation, CAPA, batch disposition and review metrics
* Prepare presentations for management review and routinely monitor performance to drive improvements
* Review existing quality workflows and assist in identifying areas for improvement. Write, revise and may review standard operating procedures.
* Other responsibilities as assigned
* In depth knowledge of Quality Systems and international cGMP standards
* In depth knowledge and experience with Operational Excellence Principles
* An accountable team player who is detail and quality oriented with an in-depth understanding of quality assurance principles, systems and procedures
* Excellent attitude with good verbal and interpersonal communication skills, excellent judgment, and multitasking skills who can work well in a dynamic environment
* Strong leadership and negotiation skills
* An accountable leader who is detail and quality oriented with a solid understanding of quality principles, methods, and procedures
* Critical and strategic thinking skills
* Working knowledge of GMPs and regulatory requirements (US, Canada, and EU)
* Experience generating key metrics
* Technical writing skills
ESSENTIAL DUTIES AND JOB FUNCTIONS
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.
KNOWLEDGE, EXPERIENCE AND SKILLS
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.
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.
If this is not the right move for you now but remain interested in a career at Gilead Sciences please connect with us via our talent community: https://gilead.avature.net/Gilead
Gilead Sciences, Inc. is a research-based biopharmaceutical company that discovers, develops and commercialises innovative medicines in areas of unmet medical need. With each new discovery and investigational drug candidate, we seek to improve the care of patients living with life-threatening diseases around the world. Gilead s therapeutic areas of focus include HIV/AIDS, liver diseases, cancer and inflammation, and serious respiratory and cardiovascular conditions.
As an equal opportunity employer, Gilead Sciences Inc. is committed to a diverse workforce. 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 firstname.lastname@example.org for assistance.
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