QA Specialist II

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 interpersonal communication 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.

Pay and benefits

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

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

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.

For Current Gilead Employees and Contractors

Please apply via the Internal Career Opportunities portal in Workday.