QA Specialist II

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.
 

We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Gilead and help create possible, together.
Job Description
 

QA Specialist II position in QA Packaging Support, Gilead Sciences Ireland UC Cork

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.

The Position

This role is a QA Specialist II, permanent role in the GSIUC QA Department, under the QA Packaging & Labelling Support Team.  The successful candidate will be required to perform QA review and approval of packaging and labelling associated documents, procedures, changes, qualifications 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 requirements

• Participates in authoring, reviewing and approving Standard Operating Procedures (SOPs)/other types of controlled documents

• Identifies deviations from accepted practices, exercises judgement to evaluate impact and determines appropriate actions

• Review and approval of GMP Deviation investigations and CAPAs

• Identifies problems and generates alternatives and recommendations  

• Performs QA review and approval of Master data and recipes required for operations

• Completion of routine/non-routine to more complex projects/assignments

• Reviews and evaluates proposed changes, qualification and validation documentation as related to packaging.

• Reviews routine packaging and engineering documentation including tech trial protocols and reports, risk assessments.

• May participate in QA review and approval of artwork and product master data.

• Performs internal audits and walkthroughs on behalf of the QA department to ensure site compliance to GMP

• Participates in site Strategic, Technical and Operational Excellence projects on behalf of QA and represents the QA function at relevant cross-functional meetings

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

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

Knowledge, 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 and proficiency in application of QA principles, concepts, industry practices and standards.

• 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/MS.

Behaviours:

• Positive attitude and enjoys working as part of a team

• Resilient profile with the ability to deliver in a challenging environment

• Ability to engage and manage multiple stakeholders to achieve the objective

• Curious with learning agility

• Operationally excellent

• Organised with systematic approach to prioritisation

• Process orientated to achieve the business objective

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)

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.

Please apply via the Internal Career Opportunities portal in Workday.