Quality Assurane Specialist III - Clinical Products
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POST DATE 9/2/2016
END DATE 11/3/2016
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.
May serve as QA lead on project teams, in complex quality investigations/deviations/clinical compliant investigations and Corrective Action/Preventive Action (CAPA)
Perform batch approval and release as assigned.
Review clinical manufacturing, packaging, and labeling drug product batch records, in-process quality control data, assess completeness of change controls, deviations, and test results for timely disposition of drug products intended for human clinical use and issue material status notifications
Interact with key stakeholders such as Formulation and Development, Clinical Packaging & Labeling, Clinical Supplies Management, and Regulatory Affairs to ensure that clinical drug products are manufactured in accordance with established procedures, cGMPs, and appropriate regulations.
Interface directly with contract manufacturers and alliance partners to resolve quality related issues with minimal supervision
Train junior staff and may perform other supervisor responsibilities as requested
Facilitate and participate in deviations, corrective action and preventive action (CAPA) activities, and complaints for assigned projects.
Assist management with gap assessments, streamline and improve existing workflow and quality procedures.
May serve as QA representative in coordinating with other Gilead divisions and/or contract manufacturers to conduct quality investigations and identify corrective actions.
Maintain electronic records in Trackwise, Oracle Enterprise Business Suite (EBS), Gilead Electronic Batch Review Systems, Veeva Vault, etc., and paper archives as needed Other duties as requested
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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