QC Specialist II (Data Review)

QC Specialist II (Data Review)
United States - New Jersey - Morris PlainsUnited States - California - Oceanside

Gilead Sciences, Inc. is a research-based bio-pharmaceutical company that discovers, develops and commercializes 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.

Making an impact on a global scale
Inclusion is one of the company’s five core values. That’s because we know that we are stronger and more innovative at Gilead when we are informed by a diverse set of backgrounds, experiences and points of view. Gilead Sciences is a biopharmaceutical company that discovers, develops and commercializes innovative therapeutics in areas of unmet medical need. The company's mission is to advance the care of patients suffering from life-threatening diseases worldwide.

When you join Gilead, you join our mission to change the world by enabling people to live healthier and more fulfilling lives. Come join a mission-driven bio-pharmaceutical organization that values inclusion and diversity, has a strong portfolio of products, and is constantly #CreatingPossible

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Job Description


QC Specialist II (Data Review)

The successful candidate will fully understand GMP, GDP, Data Integrity, and Quality Control. This role will have responsibility for the data review generated by CxO's to support product release. The candidate will partner with internal and external partners to source, monitor, and manage CxO data as it related to product release.

Job Responsibilities

• Efficient and thorough review of cGMP data associated with testing of commercial product release, stability, critical reagent qualifications and test method qualifications, validation and transfer generated by Contract Testing Laboratories (CTLs)
• Ensure timelines for data review are met in support of batch release and product supply
• Ensures that standards for documentation comply with SOPs, protocols, analytical methods, Good Documentation Practices (GDP) and industry standards.
• Strong technical knowledge including an understanding of laboratory procedures, methodology and standards.
• Review laboratory logbooks, data packages, labeling and other documentation to ensure compliance with SOPs and industry guidelines.
• Reviews raw data, protocols, reports, and certificates of analysis.
• Compile and summarize QC raw data in various physical and electronic report formats.
• Provides guidance and training to QC personnel to support company training in the procedures used to effectively execute test data review.
• Participates in compliance-focused teams working towards the goal of continuous improvement of procedures and practices.
• Coordinate and track progress of analytical testing at CTLs
• Support Change Controls, Laboratory Investigations, Deviations and CAPAs
• Participate in regulatory agency audits and inspections

Knowledge & Skills

• Exceptional attention to detail in documentation, good organizational and time management skills.
• Excellent oral and written communication for effective interpersonal collaboration with the ability to multitask/prioritize while working under restrictive timelines.
• Ability to work in a highly regulated (commercial GMP) team environment and perform job responsibilities with minimal supervision.

Education & Experience

• 4+ years of experience with Bachelor's degree in a relevant scientific discipline OR 2+ years of experience with Master's degree in a relevant scientific discipline.

• Sufficient knowledge to recognize issues with data integrity, GDP errors, out of specifications (OOS), out of trends (OOT) and adverse results.
• Experience with the following assays is a plus: CE-SDS, Cell Binding, Protein ID, Cytotoxicity, ELISA, HPLC/UPLC, CEX, Bioburden, Endotoxin, pH, appearance, and osmolality.
• Strong familiarity with Good Manufacturing Practices (GMPs), 21 CFR, Data Integrity and ALCOA principles.

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As an equal opportunity employer, Gilead Sciences Inc. is committed to a diverse workforce. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, gender, 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 careers@gilead.com for assistance.

Following extensive monitoring, research, consideration of business implications and advice from internal and external experts, Gilead has made the decision to require all U.S., Canada, Australia, Singapore, and Hong Kong employees and contractors to receive the COVID-19 vaccines as a condition of employment. “Full vaccination” is defined as two weeks after both doses of a two-dose vaccine or two weeks since a single-dose vaccine has been administered. Anyone unable to be vaccinated, either because of a sincerely held religious belief or a medical condition or disability that prevents them from being vaccinated, can request a reasonable accommodation.​

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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 log onto your Internal Career Site to apply for this job.






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