QA Specialist II

Job DescriptionFor Current Gilead Employees and Contractors:Please log onto your to apply for this job.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. Join Gilead and help create possible, together.Job DescriptionQA Specialist II position in QA General Operations, Gilead Sciences Ireland UC CorkGilead 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.The PositionThis role is a QA Specialist II, permanent role in the GSIUC QA Department, under the QA General Operations team. This specific role is required to perform QA review of manufacturing, QC and engineering records & associated documents and QA review & approval of procedures and GMP deviations. This position requires a sound knowledge of quality assurance systems, methods and procedures. The candidate will be required to exercise judgment, within well-defined and established procedures and practices, to identify problems and appropriate actions and to generate alternatives and recommendations within defined processes. The candidate must be proactive in their daily activities and interactions.Essential Duties and Job Functions:Performs a variety of activities to ensure compliance with applicable cGxP regulatory requirementsReviews routine manufacturing, QC and engineering documentation including batch manufacturing records Assists in the completion of Manufacturing related customer complaint investigationsParticipates in authoring, reviewing and approving Standard Operating Procedures (SOPs)/other types of controlled documentsIdentifies deviations from accepted practices, exercises judgement to evaluate impact and determines appropriate actionsReview and approval of GMP Deviation investigations and CAPAsIdentifies problems and generates alternatives and recommendations Completion of routine/non-routine to more complex projects/assignmentsPerforms internal audits and walkthroughs on behalf of the QA department to ensure site compliance to GMPParticipates in site Strategic, Technical and Operational Excellence projects on behalf of QA and represents the QA function at relevant cross-functional meetingsNormally receives very little instruction on routine work, general instructions on new assignmentsKnowledge, Experience and Skills:Prior experience in pharmaceutical industry is preferred (ideally within a QA role)Working knowledge of current Good Manufacturing Practices (cGMPs) (FDA / EMEA standards and quality systems)Demonstrates working knowledge of quality assurance systems, methods and procedures.Basic knowledge of OPEX Lean tools, 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 skills.Proficiency in Microsoft Office applications.Typical Education & Experience:Relevant experience in a GMP environment related field and a BS./MSBehaviours:Positive attitude and enjoys working as part of a teamResilient profile with the ability to deliver in a challenging environmentAbility to engage and manage multiple stakeholders to achieve the objectiveCurious with learning agilityOperationally excellentOrganised with systematic approach to prioritisationProcess orientated to achieve the business objectiveGilead 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 to apply for this job.