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Gilead Sciences, Inc. QA Specialist II, QA Systems & Monitoring Team, Cork in Cork, Ireland

For Current Gilead Employees and Contractors:

Please log onto your Internal Career Site at!CK5mGhEKBggDEMenAhIHCgUI1A0QcQ/cacheable-task/2997$2151.htmld to apply for this job.

Job Description


This role is a Grade 26 QA Specialist II FTE role in the GSIUC QA Department, under the Quality Systems and Monitoring team. This specific role is required to primarily support the compilation of data for annual product quality reviews, site Quality System metric generation and reporting, QA support for system changes and associated validation activities and issues as well as customer complaint investigations.

This experienced position requires requiring sound knowledge of quality assurance systems, methods and procedures. Previous experience in validation and qualification documentation review is an advantage.

The successful candidate will be required to exercise judgment within well-defined and established procedures and practices to determine appropriate action, to identify problems and to generate alternatives and recommendations within defined processes.

Job Responsibilities

As part of team of other QA specialists, the candidate may be responsible for performing a wide variety of activities to ensure compliance with applicable regulatory requirements:

  • Complies and presents reports on site quality system metrics.

  • Maintains routine programs and processes to ensure high quality products and compliance with current Good Manufacturing Practices (GMPs).

  • Participates in the writing of annual product reviews.

  • Leading customer complaint investigation coordination.

  • Coordinating or leading investigations and corrective and preventive actions (CAPA).

  • Provides support for onsite departments in assessing and approving quality system record such as deviations, change controls and document updates.

  • Acts as a lead QA support and signoff for projects and related validation activities.

  • Participates in developing Standard Operating Procedures (SOPs) to ensure quality objectives are met

  • Participates in the development of training programs regarding all aspects of producing quality products.

Normally receives very little instruction on routine work, general instructions on new assignments.

Knowledge and Skills Required

  • Working knowledge of current Good Manufacturing Practices (GMPs)

  • Working knowledge of quality assurance systems, methods and procedures.

  • Knowledge of FDA / EMEA standards and quality systems.

  • Basic knowledge of six sigma, LEAN, and root cause analysis tools used for identifying and correcting deviations.

  • Demonstrates audit and investigation skills, and report writing skills.

  • Good verbal, written, and interpersonal communication and presentation skills.

  • Demonstrates proficiency in Microsoft Office applications.

Typical Education and Experience

  • Relevant experience in a GMP environment related field and a BS.

  • Relevant experience and a MS.

  • Prior experience in pharmaceutical industry is preferred.

Gilead Core Values

  • Integrity (always doing the right thing),

  • Teamwork (collaborating in good faith),

  • Excellence (working at a high level of commitment and capability)

  • Accountability (taking personal responsibility).

  • Inclusion (encouraging diversity)

Equal Employment Opportunity (EEO)

It is the policy of Gilead Sciences, Inc. and its subsidiaries and affiliates (collectively "Gilead" or the "Company") to recruit select and employ the most qualified persons available for positions throughout the Company. Except if otherwise provided by applicable law, all employment actions relating to issues such as compensation, benefits, transfers, layoffs, returns from layoffs, company-sponsored training, education assistance, social and recreational programs are administered on a non-discriminatory basis (i.e. without regard to protected characteristics or prohibited grounds, which may include an individual’s gender, race, color, national origin, ancestry, religion, creed, physical or mental disability, marital status, sexual orientation, medical condition, veteran status, and age, unless such protection is prohibited by federal, state, municipal, provincial, local or other applicable laws). Gilead also prohibits discrimination based on any other characteristics protected by applicable laws.

For Current Gilead Employees and Contractors:

Please log onto your Internal Career Site at!CK5mGhEKBggDEMenAhIHCgUI1A0QcQ/cacheable-task/2997$2151.htmld to apply for this job.

Gilead Sciences, Inc. is a research-based biopharmaceutical company that discovers, develops and commercialises 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. Gilead’s therapeutic areas of focus include HIV/AIDS, liver diseases, cancer and inflammation, and serious respiratory and cardiovascular conditions.

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