Quality Engineering & Testing, IT QA Documentation Lead

Location
Raleigh
Salary
See job description.
Posted
February 26 2021
Ref
R0017591
Position Type
Full Time
Organization Type
Pharma
Job Type
Technician


Quality Engineering & Testing, IT QA Documentation Lead
United States - North Carolina - Raleigh

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. Gileads 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 companys five core values. Thats 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


Gilead Sciences, Inc. is a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for more than three decades, with the goal of creating a healthier world for all people. The company is committed to pursuing scientific invention to prevent and treat life-threatening diseases, including HIV, viral hepatitis and cancer. Gilead has operations in more than 35 countries worldwide, with headquarters in Foster City, California.

You will be part of a team that is helping millions of people live healthier, more fulfilling lives. We are a close community where every individual matters and everyone has a chance to enhance their skills through ongoing development. Inclusion is one of our core values, which means we are creating and fostering a work environment where our differences are valued, and everyone feels respected and empowered to bring their authentic selves to work. By joining Gilead, you will further our mission to discover, develop and deliver innovative therapeutics for people with life-threatening diseases.

The Gilead Business Services center in Raleigh's Research Triangle region will be home to some of the company's critical shared service teams in North America, including Information Technology, Global Financial Solutions, HR Operations and Procurement Services Desk. These functions provide the necessary support to ensure Gilead's business runs effectively and efficiently. The center will also be a catalyst for standardization of processes, digital transformation and technology optimization.

Quality Engineering & Testing, IT QA Documentation Lead will have expertise and experience in document control and records management, has a general knowledge of biopharmaceutical manufacturing and a good understanding of GXP regulations.

This role is a subject matter expert in document control develop, author, edit, format, illustrate, update and create new standard operating procedures and other related documentation. Primary responsibilities include managing documentation workflows to meet departmental needs; onsite and offsite archival and tracking of records; maintenance of the site archive and retrieval of records to support audits, inspections and investigations; issuing GXP documentation to respective departments. This role will interface closely with other cross-functional groups within IT functional area.

Job Duties and Responsibilities:
  • Establish and manage document workflows in Gilead's electronic document management system ensuring documents go through controlled document life cycle in accordance established procedures.
  • Ensure documents meet formatting and template requirements, adhere to required review and approval requirements and project timelines.
  • Manage GXP documentation tracking, reconciliation and archiving
  • Manage high density file room inventory, filing, and scanning. Manage offsite document archival with approved vendors
  • Perform documentation activities in eDMS and work with departments on documentation needs.
  • Provide site training on document workflow modules
  • Author or revise standard operating procedures related to document control, as needed
  • Provide documentation support during client audits and regulatory inspections.
  • Assists with the improvement of quality compliance by recognizing continuing issues and bringing them to management's attention
  • Subject Matter Expert (SME) in assigned scope of controlled document lifecycle and records management process
  • Communicates internally, inter-organizationally and with cross site document management contacts frequently
  • Maintains quality system program requirements, e.g., record retention and destruction, legal hold
  • Support compilation of department metrics and report out to management
Basic Qualifications:
High School Degree and Eleven Year's Experience OR Associates Degree and Nine Year's Experience OR Bachelor's Degree and Seven Years' Experience OR Masters' Degree and Five Years' Experience

Preferred Qualifications:
  • Hands on work experience in a cGMP environment
  • Hands on experience in writing GxP standard operating procedures which adhere to regulatory requirements
  • Proven ability to successfully coordinate new quality initiatives while managing daily responsibilities.
  • Excellent communication, analytical, and organizational skills, using modern technology platforms.
  • Highly collaborative team player who fosters open communication and facilitates mutual understanding and cooperation between all stakeholders
  • Ability to draft and implement procedures, work instructions, and appropriate procedures for a cGMP Quality System, Document Control.

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:

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


To apply, visit https://gilead.wd1.myworkdayjobs.com/en-US/gileadcareers/job/United-States---North-Carolina---Raleigh/Quality-Engineering---Testing--IT-QA-Documentation-Lead_R0017591-2





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