QA Specialist II - QC Analytical Data Review

Location
Morris Plains, New Jersey
Posted
Jul 21, 2021
Ref
2252998
Required Education
Bachelors Degree
Position Type
Full time
QA Specialist II - QC Analytical Data Review
United States - New Jersey - Morris Plains

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


QA Specialist II - QC Analytical Data Review

Gilead Sciences, Inc. is a research-based biopharmaceutical company founded in 1987. Together we deliver life-saving therapies to patients in need. With the commitment and drive you bring to the workplace every day, you will be part of a team that is changing the world and helping millions of people live healthier, more fulfilling lives. Our worldwide staff is a close community where you can see the tangible results of your contributions, where every individual matters, and everyone has a chance to enhance their skills through ongoing development. Our scientific focus has resulted in marketed products that are benefiting hundreds of thousands of people, a pipeline of strong late-stage drug candidates, and unmatched patient access programs to ensure medications are available to those who could otherwise not afford them. By joining Gilead, you will further our mission to address unmet medical needs and improve life by advancing the care of patients with life-threatening diseases.

Role and Responsibilities:

Provide QA review of cGMP QC data (Analytical and Microbiology) required to support Product Disposition activities, Analytical Method Qualification and Transfers, Validation Protocol and Reports approvals, Cleaning Verification, Stability and Environmental Monitoring Data as part of the QA Operations oversight. Assists in the identification, generation and quality approval of investigation records that may result during day-to-day operations. Assure the quality of manufactured products complies with all applicable regulations and guidelines.

Essential Duties and Job Functions:
  • Reviews cGMP QC Analytical and Microbiology documentation associated with in-process and release testing data to support batch disposition activities of Biological Product to ensure adherence to Gilead policies, SOPs, and cGMP requirements.
  • Performs Environmental Monitoring data review in support of batch release process in accordance with specifications and SOPs.
  • Performs cGMP Data Audit Trials review of data captured or generated by Quality Laboratory Systems specific to a given sample/analysis in conjunction with review of the associated data.
  • Reviews the overall QC data generated by the Stability QC team, including the review of Raw Data.
  • Reviews the QC data associated with Analytical and Microbiology Method Qualification and Transfers processes.
  • Performs Validation and Report protocols review, auditing the reported QC data.
  • Writes, reviews, and approves Standard Operating Procedures (SOPs), as needed.
  • Supports QC groups (Analytical and Microbiology) and staff as needed to identify and address product quality and compliance issues as they arise.
  • Reviews QC documentation associated with production operations. Ensures adequate levels of documentation are acceptable and compliant to existing procedures.
  • Initiates deviation reports and participate in activities for issue resolution.
  • Participates in writing and approving laboratory investigations (OOS/OOS).
  • Participates in activities associated with event resolution and CAPAs with a focus on organizing and attending cross-functional meetings.
  • Implements and ensures adherence of appropriate regulations and Gilead quality standards.
  • Supports operations to encourage a Quality Culture and ensure a safe working environment.
  • Provides training to QA personnel where appropriate.


Knowledge, Experience and Skills:
  • Strong technical knowledge including an understanding of laboratory procedures, methodology and standards, including Cell Binding Testing, HPLC/UPLC and Viral testing, MET and Endotoxin testing.
  • Biologics QC (Analytical and Microbiology) experience.
  • Prior experience in a pharmaceutical environment.
  • Practice knowledge and understanding of cGMPs.
  • Excellent written and verbal communication skills required, including responsible business communication.
  • Superior attention to detail, organizational skills, and the ability to handle multiple tasks in a timeline-driven environment necessary.
  • Must be proficient with Microsoft Office applications.

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Basic Qualifications:

2+ years of relevant experience in a GMP environment related field and an Master's degree

OR

4+ years of relevant experience in a GMP environment related field and a Bachelor's degree

To apply, please submit resume through our website at www.gilead.com

Gilead is an equal opportunity employer.

For jobs in the United States:

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.

For more information about equal employment opportunity protections, please view the ‘EEO is the Law' 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:

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