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QA Specialist I - Trenton, United States - Gilead Sciences
Description
QA Specialist IUnited States - New Jersey - Parsippany
Quality
Regular
Job Description
At Gilead, were creating a healthier world for all people.
For more than 35 years, weve tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe.
We continue to fight against the worlds biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference.
Every member of Gileads team plays a critical role in the discovery and development of life-changing scientific innovations.
Our employees are our greatest asset as we work to achieve our bold ambitions, and were looking for the next wave of passionate and ambitious people ready to make a direct impact.
We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite.
As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations.
Join Gilead and help create possible, together.Job Description
Role and Responsibilities:
Gilead Sciences is looking for a QA Specialist I, for the position of Quality Operational Lead, to join our External QA Team.
This position will provide QA oversight of Biologics Contract Manufacturing Organizations in support of Drug Substance / Drug Product manufacturing activities across clinical or commercial programs for external manufacturing operations.
Review 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 Clinical/Commercial Drug Substance/Drug Product in support of product disposition.
Review and approve master batch records, labels, specifications and other pre-production documents for Clinical/Commercial Drug Substance/Drug Product in compliance with FDA and international health agency requirements.
Support investigations and corrective and preventive action (CAPA) recommendations.Interface directly with contract manufacturers and alliance partners to manage quality related issues
Interact with key stakeholders such as Formulation and Process Development, MSAT, Manufacturing, Engineering, and Regulatory Affairs to ensure that Clinical/Commercial Drug Substance/Drug Products are manufactured in accordance with established procedures, cGMPs, and appropriate regulations.
Reviews manufacturing, environmental monitoring and quality control data with guidance from senior colleagues.Works with operating entities with guidance from senior colleagues 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 assist lead/coordinator with investigations and corrective and preventive action (CAPA) relating to manufactured products.May work with Research and Development during new product start-ups, with guidance from senior colleagues.
Supports writing and revising standard operating procedures.
Normally receives general instruction on routine work, detailed instructions on new assignments.
Knowledge, Experience and Skills:
Good working knowledge of Quality Systems and cGMP standards applicable to commercial and clinical development
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 judgement, and multitasking skills who can work well in a dynamic environment
Self starter, able to work independently
Able to travel infrequently (less than 5 %)
Requirements:
2+ years of relevant experience in a GMP environment related field and a BS ( OR)
0+ years of relevant experience in a GMP environment related field and a MS
Prior experience in pharmaceutical industry is beneficial.
Demonstrates basic knowledge of current Good Manufacturing Practices (GMPs) and/or Good Laboratory Practices (GLPs).
Demonstrates basic knowledge of FDA / EMEA standards and quality systems.
Demonstrates good verbal, written, and interpersonal communication skills.
Demonstrates working knowledge in Microsoft Office applications.
Job Description
At Gilead, were creating a healthier world for all people.
For more than 35 years, weve tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe.
We continue to fight against the worlds biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference.
Every member of Gileads team plays a critical role in the discovery and development of life-changing scientific innovations.
Our employees are our greatest asset as we work to achieve our bold ambitions, and were looking for the next wave of passionate and ambitious people ready to make a direct impact.
We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite.
As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations.
Join Gilead and help create possible, together.Job Description
Role and Responsibilities:
Gilead Sciences is looking for a QA Specialist I, for the position of Quality Operational Lead, to join our External QA Team.
This position will provide QA oversight of Biologics Contract Manufacturing Organizations in support of Drug Substance / Drug Product manufacturing activities across clinical or commercial programs for external manufacturing operations.
Review 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 Clinical/Commercial Drug Substance/Drug Product in support of product disposition.
Review and approve master batch records, labels, specifications and other pre-production documents for Clinical/Commercial Drug Substance/Drug Product in compliance with FDA and international health agency requirements.
Support investigations and corrective and preventive action (CAPA) recommendations.
Interface directly with contract manufacturers and alliance partners to manage quality related issues
Interact with key stakeholders such as Formulation and Process Development, MSAT, Manufacturing, Engineering, and Regulatory Affairs to ensure that Clinical/Commercial Drug Substance/Drug Products are manufactured in accordance with established procedures, cGMPs, and appropriate regulations.
Reviews manufacturing, environmental monitoring and quality control data with guidance from senior colleagues.
Works with operating entities with guidance from senior colleagues 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 assist lead/coordinator with investigations and corrective and preventive action (CAPA) relating to manufactured products.
May work with Research and Development during new product start-ups, with guidance from senior colleagues.
Supports writing and revising standard operating procedures.
Normally receives general instruction on routine work, detailed instructions on new assignments.
Knowledge, Experience and Skills:
Good working knowledge of Quality Systems and cGMP standards applicable to commercial and clinical development
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 judgement, and multitasking skills who can work well in a dynamic environment
Self starter, able to work independently
Able to travel infrequently (less than 5 %)
Requirements:
2+ years of relevant experience in a GMP environment related field and a BS ( OR)
0+ years of relevant experience in a GMP environment related field and a MS
Prior experience in pharmaceutical industry is beneficial.
Demonstrates basic knowledge of current Good Manufacturing Practices (GMPs) and/or Good Laboratory Practices (GLPs).
Demonstrates basic knowledge of FDA / EMEA standards and quality systems.
Demonstrates good verbal, written, and interpersonal communication skills.
Demonstrates working knowledge in Microsoft Office applications.
The salary range for this position is: $78, $101, 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*.For additional benefits information, visit:
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 contactfor assistance.
For more information about equal employment opportunity protections, please view the 'Know Your Rights'
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.
For jobs in France:
Conformment la Loi Informatique et Liberts (06/01/78), nous vous informons du fait que les donnes personnelles renseignes pourront faire l'objet d'un traitement informatique par Gilead et pourront tre transmises aux Organismes Sociaux.
Par ailleurs, vous disposez d'un droit d'accs, de rectification et de suppression des donnes vous concernant.Vous pouvez exercer ce droit en contactant:
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Job Level
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