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Gilead

QA Specialist II -Computer Systems Validation

For Current Gilead Employees and Contractors:

Please log onto your Internal Career Site to apply for this job.

Job Description

Working in QA at Gilead:

Quality Assurance delivers on Gilead’s commitment to bring life-changing therapies to patients through the robust QA processes and systems. Our approach is agile, innovative and collaborative and our teams are genuinely committed to the rapid delivery of safe life changing therapies. As part of the broader Pharmaceutical Development & Manufacturing (PDM) team you will be part of a team that is changing the world and helping millions of people live healthier, more fulfilling lives. You will see the tangible results of your contributions, where every individual matters, and everyone has a chance to enhance their skills through on-going 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 QA within PDM, you will further our mission to address unmet medical needs and improve life by advancing the care of patients with life-threatening diseases.

Meet the worldwide QA Team: https://qualityassurance-careers.gilead.com/

Specific Responsibilities


Gilead is currently seeking a QA Specialist II for our world class API manufacturing facility in Edmonton, Alberta. This role will support general QA needs as well as Computer Systems Validation for QA.

Essential Duties and Job Functions:

  • Provides QA support for GxP computer systems in lab and manufacturing environments.
  • Provides quality oversight for GxP computer systems and processes to ensure compliance with the regulations such as GMPs, GLPs and 21 CFR Part 11.
  • Reviews GxP documents and ensures compliance with company procedures and applicable regulatory requirements.
  • Performs a wide variety of activities to ensure compliance with applicable regulatory requirements.
  • Participates in developing Standard Operating Procedures (SOPs) to ensure quality objectives are met.
  • Reviews manufacturing, environmental monitoring and quality control data for in-process and finished products.
  • Participate in review and approval of qualification and validation documentation such as protocols, plans, reports and any related quality investigations.
  • Support regulatory inspection preparedness and internal/external audits.
  • Assist in the review of batch records and audit trails.

Knowledge, Experience and Skills:

  • Experience in computerized system validation.
  • Experience with laboratory instruments such as GC, HPLCS, UPLC, IC, MS, etc.
  • Experience with laboratory platforms such as LIMs, Enterprise, Empower, Labwatch and LabX.
  • Experience with Maximo, Veeva and Trackwise.

Hands on experience on computerized systems such as DCS and PLC/SCADA.

  • Previous experience in QA in a pharmaceutical industry.
  • Experience with Batch Record review and CAPAs.
  • BS in Computer Science or related fields with over 4 years of relevant experience in a regulated industry.
  • MS in Computer Science or related fields with over 2 years of relevant experience in a regulated industry.
  • Excellent communication (verbal and technical writing) skills and strong interpersonal skills are required.


For Current Gilead Employees and Contractors:

Please log onto your Internal Career Site to apply for this job.

Apply Now

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