Quality Systems Specialist I

Location
La Verne, CA
Posted
Jun 26, 2022
Ref
2992285
Required Education
Bachelors Degree
Position Type
Full time

Quality Systems Specialist I

Roles and Responsibilities

• Conducts a comprehensive and critical evaluation of Laboratory records in support of commercial product release. Analyses to be conducted on the execution of techniques such as Titrations, Karl Fischer, UV-Vis/Fluorometer, pH/Conductivity, HPLC, GC, and Ion Chromatography. This evaluation includes, but is not limited to, content, results, data accuracy and scientific relevance, format and adherence to GMP.

• Performs a thorough review of raw data and documentation to ensure compliance to applicable specifications and protocols.

• Supports the review of contract laboratory testing

• Supports the generation of Quality Metrics and Reports

• Performs procedural and method revisions, where necessary.

• Conducts GMP review of QC laboratory records, logbooks and associated forms including electronic raw data to ensure compliance with Gilead's data integrity policy.

• Supports OOS/OOT investigation and CAPA implementation

• Assists in the laboratory method and/or instrumentation validation activities.

• Conducts off hour (early morning/late night/weekends) data review to support production needs.

• Participates in validation and commercial/developmental manufacturing activities as required

• May support on-the-job training for new team members

Qualifications
  • Bachelor's degree in Chemistry or related discipline
  • Working knowledge of quality systems and regulatory requirements (21 CRF Part 11/210/211) related to cGMP in the Manufacturing of Pharmaceuticals
  • Maintain data integrity and ensure compliance with company SOPs and specifications, FDA, USP, GLP, and cGMP regulations
  • Proficient in MS Word, Excel, Power Point and other applications
  • Excellent interpersonal, verbal and written communication skills are essential in this collaborative work environment
  • Comfortable in a fast-paced environment with minimal direction and able to adjust workload based upon changing priorities

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.

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. 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.​

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.

For Current Gilead Employees and Contractors:

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