Lab Ops Specialist II

Gilead Sciences, Inc. Foster City , CA 94404

Posted 4 months ago

For Current Gilead Employees and Contractors:

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

Job Description

Specific Responsibilities:

With the commitment and drive you bring to the Pharmaceutical Development & Manufacturing (PDM) workplace, 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 PDM at Gilead, you will further our mission to address unmet medical needs and improve life by advancing the care of patients with life-threatening diseases.

This role is for an experienced data analytics specialist for continuous generation, monitoring, assessment, and report-out of the Laboratory Operations key performance indicators (KPIs) and metrics to ensure data integrity(DI), data security, and compliance to Annex11 / 21CFR Part 11 expectations for the Analytical Operations (AO) instruments.

  • Manage the System Audit Trail Review (SATR) program for standalone laboratory instruments from design of the review process through coordination and approval of results and authoring the Semi-annual SATR Report.

  • Support DI initiatives for continuous DI improvement efforts to ensure compliance, coordinate internal audits on DI controls and procedures, and meeting increasing data processing and data acquisition demands.

  • Develop and maintain KPIs, metrics, and dashboards to monitor the performance and utilization of laboratory instruments, their maintenance, and the effectiveness of the quality assurance programs in place with respect to Laboratory Information Systems.

Essential Functions:

  • Collects data from various applications and imports data to Excel

  • Uses Excel to make multiple simple and somewhat complex calculations to represent data graphically

  • Maintains data and files to ensure accurate reporting in monthly and quarterly presentations

  • Writes significant portions of key presentations based on data presented

  • Presents data to senior management and incorporates feedback from management.

  • Manages ongoing System Audit Trail Review (SATR) program for standalone lab instruments

  • Coordinates performance of monthly SATRs by metrology professionals.

  • Reviews any and all findings from SATRs and reports to appropriate management for resolution in a timely manner.

  • Initiates formal deviations based on SATR findings and participates in deviation investigations as required.

  • Documents and tracks all findings, creating monthly, quarterly and semi-annual presentations and reports as part of the official quality record.

  • Creates or revises standard operating procedures relevant to scope of work.

  • May coordinate and support periodic reviews of controlled documents, systems and processes.

  • Normally receives limited instructions on routine work and general instructions on new assignments.

Knowledge, Experience &

Skills:

Essential:

  • 5+ years of relevant experience in pharmaceutical or other similarly regulated industry.

  • Bachelor's degree or equivalent requisite experience in analytical chemistry, quality systems or a related field.

  • Extensive knowledge of cGMP regulations applicable to analytical instrumentation, laboratory equipment, and data integrity in pharmaceuticals or medical devices.

  • Demonstrated experience in creating professional dashboards and presentations to display, summarize, and derive meaning from large data-sets.

Desirable:

  • Experience with Crystal Reports

  • Experience with OBIEE: Oracle Business Intelligence application

  • Experience with Maximo asset management application

For jobs in the United States:

As an equal opportunity employer, Gilead Sciences Inc. is committed to a diverse workforce. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, gender, 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 careers@gilead.com for assistance.

For more information about equal employment opportunity protections, please view the 'EEO is the Law' poster.

NOTICE: EMPLOYEE POLYGRAPH PROTECTION ACT

YOUR RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE ACT

PAY TRANSPARENCY NONDISCRIMINATION PROVISION

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 jobs in France:

Conformment la Loi " Informatique et Liberts " (06/01/78), nous vous informons du fait que les donnes personnelles renseignes pourront faire l'objet d'un traitement informatique par Gilead et pourront tre transmises aux Organismes Sociaux. Par ailleurs, vous disposez d'un droit d'accs, de rectification et de suppression des donnes vous concernant. Vous pouvez exercer ce droit en contactant: FranceDataPrivacy@gilead.com

For Current Gilead Employees and Contractors:

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


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Lab Ops Specialist II

Gilead Sciences, Inc.