QA Specialist I
QA Specialist I
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Job Description
At Gilead Sciences Canada Inc. we take pride in being recognized as one of Greater Torontos Top Employer 2024. Click here to find out why Gilead Sciences Canada is a top employer!
Chez Gilead Sciences Canada Inc. nous sommes fiers dtre reconnus comme lun des meilleurs employeurs du Grand Toronto pour 2024. Cliquez ici pour en savoir plus sur les raisons de notre succs.
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
At Gilead Creating Possible drives everything we do. Its evident in our mission and core values. This is how we built a culture of excellence that is fuelled by a passion for improving the lives of people around the world and advancing the care of patients suffering from life-threatening diseases.
At Gilead we are driven to develop lifesaving products that make a difference for patients around the world. Every day we to transform the promise of science and technology into breakthrough innovative therapies that have the power to cure prevent or treat disease. As a research-based bio pharmaceutical company we are revolutionizing healthcare by bringing medicines to patients in the areas of unmet need including HIV AIDS liver diseases haematology and oncology and inflammation and respiratory diseases. When you join Gilead you join our mission to change the world by enabling people to live healthier and more fulfilling lives.
Specific Job Responsibilities:
Review executed production batch records analytical data and associated documentation including any deviation and investigation reports related to lot release of Clinical Trial Materials APIs and Commercial Drug Products in support of batch disposition with guidance from senior colleagues
Assist or coordinate with investigations corrective and preventive action (CAPA) recommendations and change controls.
Interface directly with cross functional teams and infrequently with alliance partners to manage quality related issues.
Maintains programs and processes to ensure high quality products and compliance with current Good Manufacturing Practices (GMPs) and Good Laboratory Practices (GLPs).
Participates in developing Standard Operating Procedures (SOPs) to ensure quality objectives are met.
May participate in the launch of new products for the Canadian market with guidance from senior colleagues.
Assist in departmental planning activities to ensure that deliverables are provided according to project timelines.
Performs a variety of activities to ensure compliance with applicable regulatory requirements.
Normally receives general instruction on routine work detailed instructions on new assignments.
Knowledge:
Demonstrates basic knowledge of current Good Manufacturing Practices (GMPs) and/or Good Laboratory Practices (GLPs).
Good working knowledge of Quality Systems and cGMP standards applicable to clinical development.
Demonstrates basic knowledge of Health Canada and ICH regulations and standards.
Ability to effectively participate in cross-functional teams.
May assist with compliance audits as required
An accountable team player who is detail and quality oriented with solid understanding of QA principles systems and procedures.
Demonstrates investigational skills such as root cause analysis
Demonstrates strong verbal written and interpersonal communication skills.
Demonstrates proficiency in Microsoft Office applications.
Specific Education & Experience Requirements:
2 years of relevant experience in a GMP environment related field and a BS.
Prior experience in pharmaceutical industry is beneficial.
Gilead Core Values:
Integrity (doing whats right)
Teamwork (working together)
Excellence (being your best)
Accountability (taking personal responsibility)
Inclusion (encouraging diversity)
For Current Gilead Employees and Contractors:
Please apply via the Internal Career Opportunities portal in Workday.
Required Experience:
Unclear Seniority
Employment Type
Full-Time
