QA Specialist I

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At Gilead, Creating Possible drives everything we do. It’s 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, API’s 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 what's right)

• Teamwork (working together)

• Excellence (being your best)

• Accountability (taking personal responsibility)

• Inclusion (encouraging diversity)