At Gilead, we’re creating a healthier world for all people. For more than 35 years, we’ve 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 world’s biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference. Every member of Gilead’s 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 we’re 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** _Quality Assurance Specialist II_ **Job Responsibilities** + Write/implement changes to controlled documents (SOPs, WRKs, FRMs, etc.). + Collate clinical batch release documents from IQS, GVault, GTrack and GRASP. + Maintain logs (Clinical and Commercial DP, API, Change control, etc.). + Download temperature data from ColdStream and Skelton Website. + Perform daily review of Drug Product inventory (Cycle Count), save inventory reports in the applicable folders, and notify the QA team of any inventory discrepancies. + Prepare Canadian monthly metrics for aging EETs. + Prepare Canadian quarterly metrics for drug product release, API release, complaints, deviations and EETs and QMR’s. + Track the escalations and coordinate review and approvals. + Track the quarterly complaint trend reports and forward to the Canadian senior QA management for approval. + Assist in completing the Canadian annual vendor qualification. + Prepare shipping/sampling documentation, coordinate with 3PL and testing laboratory the shipping and receipt of the samples for testing. + As part of drug product APQR, prepare annual retain inspection forms, coordinate the retain inspection with 3PL, approve completed retain inspection forms, and update APQR Canadian retains section with the results from the retain inspection. + Release of commercial drug product to the Canadian market. + Release of clinical drug product for use at the Canadian clinical trial sites. + Release of API’s in Canada for the global market. + Disposition of returns and oversight of monthly returns reconciliation. + Tracking and arranging for destruction of short-dated drug product. + Perform other duties as assigned. + Normally receives no instruction on routine work, general instructions on new assignments. + Performs a wide variety of activities to ensure compliance with regulatory requirements. + May assist with compliance audits as required. **Knowledge:** + Demonstrates proficiency in Good Manufacturing Practices (GMP’s) and/or Good Laboratory Practices (GLP’s) + Demonstrates proficiency in applications of QA principals, concepts, industry practices and standards + Demonstrates thorough knowledge of Health Canada standards and quality systems, and interfaces with other functions like supply chain, commercial operations and analytical operations. + Demonstrates strong verbal, technical writing and interpersonal skills **Basic Qualifications:** + BSc with 4+ years of relevant experience in a GMP environment. OR + MS with 2+ years of relevant experience in a GMP environment. **Preferred Qualifications:** **Prior experience in pharmaceutical industry, specifically a pharmaceutical importer is preferred.** The salary range for this position is: $102,085.00 - $132,110.00. 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: https://www.gilead.com/careers/compensation-benefits-and-wellbeing * Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans. **For jobs in the United States:** Gilead Sciences Inc. is committed to providing equal employment opportunities to all employees and applicants for employment, and is dedicated to fostering an inclusive work environment comprised of diverse perspectives, backgrounds, and experiences. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, sex, 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 contact ApplicantAccommodations@gilead.com for assistance. For more information about equal employment opportunity protections, please view the 'Know Your Rights' (https://www.eeoc.gov/employers/eeo-law-poster) poster. NOTICE: EMPLOYEE POLYGRAPH PROTECTION ACT (http://www.dol.gov/whd/regs/compliance/posters/eppac.pdf) YOUR RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE ACT PAY TRANSPARENCY NONDISCRIMINATION PROVISION (https://www.dol.gov/sites/dolgov/files/OFCCP/pdf/pay-transp\_%20English\_formattedESQA508c.pdf) 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 Current Gilead Employees and Contractors:** Please apply via the Internal Career Opportunities portal in Workday. Gilead Sciences, Inc. is a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for more than three decades, with the goal of creating a healthier world for all people. The company is committed to advancing innovative medicines to prevent and treat life-threatening diseases, including HIV, viral hepatitis and cancer. Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, California.