QA Specialist II

Regulatory Jobs; Foster City (CA); On-site; USD 102,000 - 132,000; Full time

Benefits offered by this job

Medical, dental, vision, and life保险

Discretionary annual bonus

Stock-based long-term incentives

Job summary

Gilead Sciences Inc. in Foster City, CA is seeking a QA professional to oversee clinical small molecule drug substance and OSD manufacturing. You will review batch records, deviations, investigations, and ensure ALCOA-compliant quality records.

You will support QA daily operations, lead QA projects, contribute to CAPAs, and assist in regulatory inspections and internal audits. A BS or MS in a relevant field is required along with GMP experience.

Qualifications

• 4+ years of relevant experience in a GMP environment and a BS.
• Or 2+ years of experience with an MS.
• Pharmaceutical industry experience preferred.

Responsibilities

• Supports QA oversight of clinical small molecule drug substance and OSD pilot plant manufacturing, warehouse, and product disposition.
• Reviews and approves manufacturing documentation including batch records, deviations, investigations, CAPAs, and change controls.
• Maintains ALCOA quality records in compliance with GMP and quality systems.
• Supports QA team in daily operations such as lot disposition and process improvement projects.
• Participates in cross-functional projects delivering QA deliverables in quality systems.

Skills

GMP knowledge

Quality assurance

Documentation control

Problem solving

MS Office

Education

BS in relevant field

MS in related field

Tools

Quality management software

Microsoft Office

Job description

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

Specific Job Responsibilities:

• Supports QA oversight of clinical small molecule drug substance and oral solid dosage (OSD) pilot plant manufacturing, warehouse, and is responsible for product disposition utilizing risk-based and clinical phase appropriate approach.

• Reviews and approves manufacturing documentation which may include batch records, product release documentation, deviations, investigations (i.e. OOS, OOT, atypical), CAPAs, change controls, protocols and reports.

• Maintains accurate, complete, and timely (ALCOA) quality records in accordance with GMP and quality systems.

• Supports QA team members in daily operations such as lot disposition and team process improvement projects.

• Participates in departmental and cross-functional projects, delivering assigned QA deliverables in compliance with quality systems.

• Supports small to moderately complex process improvement projects.

• Executes basic root cause analysis and uses risk-based thinking to support investigations and quality events.

• Helps identify data trends, anomalies, and potential compliance risks and escalates appropriately.

• Leads revision of GMP documentation to support QA projects.

• Creates metrics and reports under the supervision of senior QA team members.

• Supports regulatory inspections, internal audits, including preparation, execution, and observation response generation.

Knowledge:

• Demonstrates working knowledge of current Good Manufacturing Practices (cGMPs).

• Demonstrates working knowledge of quality assurance systems, methods and procedures.

• Demonstrates knowledge of FDA / EMEA standards and quality systems.

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

• Demonstrates good verbal, written, and interpersonalcommunication skills.

• Demonstrates proficiency in Microsoft Office applications.

Basic Qualifications:

• 4+ years of relevant experience in a GMP environment related field and a BS.

OR

• 2 + years of relevant experience and a MS.

• Prior experience in pharmaceutical industry is preferred.

The salary range for this position is: $102,085.00 - $132,110.00. Gilead considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. These considerations mean actual compensation will vary. This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary based on role), paid time off, and a benefits package.

Benefits include company-sponsored medical, dental, vision, and life insurance plans*.

For additional benefits information, visit:

https://www.gilead.com/careers/compensation-benefits-and-wellbeing

* Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans.

For jobs in the United States:

Gilead Sciences Inc. is committed to providing equal employment opportunities to all employees and applicants for employment, and is dedicated to fostering an inclusive work environment comprised of diverse perspectives, backgrounds, and experiences. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, sex, 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 [e-mail] for assistance.

For more information about equal employment opportunity protections, please view the 'Know Your Rights' poster.

NOTICE: EMPLOYEE POLYGRAPH PROTECTION ACT

YOUR RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE ACT

Gilead Sciences will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, (c) consistent with the legal duty to furnish information; or (d) otherwise protected by law.

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.