Sr. Specialist, QA Compliance - Equipment Calibration Qualification

Location
Morris Plains, New Jersey
Posted
Jul 21, 2021
Ref
2239388
Required Education
Bachelors Degree
Position Type
Full time
Sr. Specialist, QA Compliance - Equipment Calibration Qualification
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


Sr. Specialist, QA Compliance - Equipment Calibration Qualification

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 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 equipment and instrumentation required to support manufacturing and testing at the Morris Planes, NJ site. Assists in the identification, generation and quality approval of investigation records that may result during day-to-day operations. Assure the quality of equipment records complies with all applicable regulations and guidelines.

Essential Duties and Job Functions:
  • Provide Quality oversight of Equipment commissioning, qualification, and validation activities
  • Provide Quality oversight of equipment Calibration and Preventive Maintenance Programs and activities.
  • Responsible for managing the review/approval of commissioning documentation, validation protocols (including associated discrepancies), reports and support records to certify compliance with specifications and procedures; ensures timely resolution of documentation, compliance, and quality system issues.
  • Reviews and assists in investigating deviations related to manufacturing process equipment, utilities, automation, calibration, preventative maintenance, validation, and laboratory instrumentation.
  • Responsible for performing change control assessments and reviewing/approving change control implementation plans for equipment, utilities, and manufacturing and/or laboratory systems
  • Monitors daily activities within area of Equipment and Calibration, directing work flow based on maintaining compliance and takes corrective action against exceptions.
  • Create, review and/or approve appropriate policies, directives and procedures in alignment with relevant governmental regulations/guidelines 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:
  • 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 MS Office applications.
  • BS/BA in (U.S. or foreign equivalent) in Microbiology, Biology, Chemistry, Biotechnology, Biopharmaceuticals or related field.
  • Experience in equipment qualification, IT systems, automation, operations and manufacturing within the biotechnology/pharma industry and in new manufacturing facility environment is a plus.
  • Practice knowledge and understanding of cGMPs.
  • Biologics QC (Analytical and Microbiology) experience.


Basic Qualifications:
  • 7+ years of relevant experience in the pharmaceutical industry and a BS or BA degree.


If this is not the right move for you now but remain interested in a career at Gilead Sciences please connect with us via our talent community: https://gilead.avature.net/Gilead

About Gilead:

Gilead Sciences, Inc. is a research-based biopharmaceutical 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.

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.

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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.

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