Overview
QA Tester – Hybrid, PA Jobs in Philadelphia, PA at Ocean Blue Solutions
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
Gilead’s mission is to discover, develop, and deliver therapies that will improve the lives of patients with life-threatening illnesses
worldwide. As a QA Specialist I, you are responsible for:
Key Responsibilities:
Maintains programs and processes to ensure high quality products and compliance with current Good Manufacturing Practices (GMPs).
Compile and verify all batch related documents are complete to support lot release.
Reviews manufacturing, environmental monitoring and quality control data for in process and finished products with minimal guidance from senior colleagues
Elevate any issues affecting lot manufacturing or release to Management in a timely manner
Ensure that any Deviations in executed Manufacturing Production Records are appropriately identified
Ensure that manufacturing Deviation, Change Management, and other records to support lot release are acceptable.
Prioritize lot release of various product types (sterile/parenteral, solid dose, finished goods, and clinical)
Gather metrics related to lot release, quarterly business reviews, and annual product reviews
May develop training programs related to Batch Record Review and Release processes
Participate in revision of Batch Record Review and Release SOPs/forms
Basic Qualifications:
Demonstrates basic knowledge of current Good Manufacturing Practices (GMPs).
Demonstrates basic knowledge of FDA / EMEA standards and quality systems.
Demonstrates good verbal, written, and interpersonal communication skills.
Demonstrates working knowledge in Microsoft Office applications.
Specific Education & Experience Requirements:
BS with at least 2 years of relevant experience in a GMP environment.
OR
AA degree with at least 3 years of relevant experience in a GMP environment.
Preferred Qualifications:
At least 4 years’ of relevant experience in Quality Assurance, Quality Control, or a cGMP related field within a biotechnology, biologics, or pharmaceutical manufacturing facility
Working knowledge of cGMP, quality systems and regulatory requirements (21 CRF Part 11/210/211, etc.) practices/principles
General knowledge of aseptic manufacturing processes
Experience with information systems (LIMS, MES, Oracle EBS)
Experience with internal and external audit
Experience with Health Authority Regulations and Validation practices/principles
Knowledge of IQ/OQ/PQ
The salary range for this position is: $80,325.00 – $103,950.00. 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
[email protected]
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
PAY TRANSPARENCY NONDISCRIMINATION PROVISION
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.
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Title: QA Tester – Hybrid, PA
Company: Ocean Blue Solutions
Location: Philadelphia, PA
