QA Specialist I

QA Specialist I
Canada - Alberta - Edmonton

Gilead Sciences, Inc. is a research-based bio-pharmaceutical company that discovers, develops and commercializes 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. Gileads therapeutic areas of focus include HIV/AIDS, liver diseases, cancer and inflammation, and serious respiratory and cardiovascular conditions.

Making an impact on a global scale
Inclusion is one of the companys five core values. Thats because we know that we are stronger and more innovative at Gilead when we are informed by a diverse set of backgrounds, experiences and points of view. Gilead Sciences is a biopharmaceutical company that discovers, develops and commercializes innovative therapeutics in areas of unmet medical need. The company's mission is to advance the care of patients suffering from life-threatening diseases worldwide.

When you join Gilead, you join our mission to change the world by enabling people to live healthier and more fulfilling lives. Come join a mission-driven bio-pharmaceutical organization that values inclusion and diversity, has a strong portfolio of products, and is constantly #CreatingPossible

['QA Specialist I

Gilead Sciences, Inc. is a research-based biopharmaceutical company founded in 1987. Together we deliver life-saving therapies to patients in need. With the commitment and drive you bring to the workplace every day, you will be part of a team that is changing the world and helping millions of people live healthier, more fulfilling lives. Our worldwide staff is a close community where you can see the tangible results of your contributions, where every individual matters, and everyone has a chance to enhance their skills through ongoing 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 Gilead, you will further our mission to address unmet medical needs and improve life by advancing the care of patients with life-threatening diseases.

Gilead Alberta QA department is seeking a highly motivated individual who is able to work effectively in a multi-disciplinary team environment.

Job Responsibilities:

• Performs a variety of activities to ensure compliance with applicable regulatory requirements.
  
• Reviews executed batch records and batch equipment cleaning records for Active Pharmaceutical Ingredients (APIs). Reviews environmental monitoring and quality control data.
  
• Performs routine review and in-depth review of analytical data packages for Active Pharmaceutical Ingredients (APIs), API intermediates, raw materials, equipment cleaning verification and water testing.
  
• Conduct QA walkthroughs in site operational areas; may participate in site internal audit and support inspection readiness activities.
  
• Works with managers to identify procedural GAPs in current workflow and perform tasks to mitigate risks.
  
• Preparing compliance statements and Certificates of Analysis
  
• Assists in leading/coordinating with investigations and corrective and preventive actions (CAPAs) related.
  
• Coordinates with operational departments to ensure materials and documentation are compliant and available for manufacturing.
  
• Normally receives no instruction on routine work, general instructions on new assignments.
  

Knowledge and Skills:

• Ability to work on routine, non-routine and complex projects/assignments where analysis of situation or data requires a review of simple and identifiable factors.
  
• Ability to exercise judgment within well-defined and established procedures and practices to determine appropriate action - identifies problems and generates alternatives and recommendations within defined processes.
  
• Coordinating, planning, organization, and implementation of projects within specified objectives.
  
• Thinking critically and creatively, wile being able to work independently.
  
• Prioritizing tasks to ensure the critical tasks are completed on time and met requirements.
  
• Superior communication skills (verbal, written) and strong interpersonal skills are required.
  
• Demonstrates working knowledge in Microsoft Office applications, especially Word, Excel, and PowerPoint.
  
• Previous experience in pharmaceutical industry is beneficial.
  

Minimum Qualifications:

Bachelor's degree and 2+ years of relevant experience in a GMP environment related field; or Associate's degree and 3+ years of relevant experience.


For Current Gilead Employees and Contractors:
Please log onto your Internal Career Site to apply for this job.
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To apply, visit https://gilead.wd1.myworkdayjobs.com/en-US/gileadcareers/job/Canada---Alberta---Edmonton/QA-Specialist-I_R0019680





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