Quality Assurance Documentation Lead

Employer
Kite Pharma
Location
Gaithersburg, MD, United States
Posted
Sep 02, 2020
Ref
R0014879
Required Education
High School or equivalent
Position Type
Full time
Kite is continuing to hire for all open roles. Our interview process may be conducted virtually and some roles will be asked to temporarily work from home. Over the coming weeks and months, we will be implementing a phased approach to bringing employees back to site to ensure the health and safety of our teams.

For Current Kite Pharma Employees and Contractors:

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

Job Description

Kite, a Gilead Company, is a biopharmaceutical company focused on the development and commercialization of novel cancer immunotherapy products designed to harness the power of a patient's own immune system to selectively target and kill cancer cells. Our core technology involves the genetic engineering of T cells, or white blood cells, to express either chimeric antigen receptors (CARs) or T cell receptors (TCRs) for the treatment of advanced solid and hematological malignancies. We are on a rapid growth trajectory and have a highly energized and accomplished team working towards new frontiers for cancer patients.

Everyone at Kite is grounded by one common goal - curing cancer. Every single day, we seek to establish a direct line between that purpose and our day-to-day work. Would you like to join us in this mission?

We are seeking a highly motivated individual to join our team as Quality Assurance (QA) Documentation Control Lead at our clinical production facility in Gaithersburg, Maryland. The facility is being developed as a Center of Excellence for the advancement of novel TCR mediated T cell therapies targeting tumor mutations (neoantigens) and antigens. Working on the Neoantigen Quality team, the QA Doc. Control Lead will play a key role in implementing quality systems associated with document management and focus on batch record documentation issuance and process improvement accuracy.

Responsibilities:
  • Maintain a document management system aligned with regulatory, quality, and Kite requirements.
  • Lead all documentation and records issuance and archival processes to support manufacturing process.
  • Provide mentorship and advice on approved procedures, standardization and requirements associated with the document management system.
  • Manage effective documents including procedures, forms, specifications, and batch documentation.
  • Manage and perform archival of documents in collaboration with Kite's network and Kite's suppliers, including management of associated electronic systems/databases.
  • Handle document control inventory supply and place requisitions.
  • Ensure accuracy by reviewing documents for completeness, proper authorization and impact to other quality systems.
  • Collaborate with cross-functional departments to ensure timely implementation of document change controls and requests.
  • Assign lot related documentation and labels for manufacturing process.
  • Print, compile and issue all lot-related documentation (batch records, labels, sample plans, specifications etc.)
  • Own Document Control-specific quality records, including deviations, CAPA, CCs and audit responses.
  • Improve, execute and maintain the document change control system.
  • Investigate deviations against the document management system and develop effective corrective action plans.
  • Build and support tracking and communication of site metrics to management.
  • Provide troubleshooting assistance for users regarding documents in Learning Management Systems and accessing training items.
  • Identify and raise compliance gaps across the document management system.
  • Execute critical initiatives to improve the document management system.
  • Develop and conduct training to new staff on document management processes, procedures and label issuance.
  • Support audits (internal, external) as document management SME.


Requirements:

Masters' degree with a minimum of 4+ years of combined technical experience in a GMP related field within a biotechnology, biologics, or pharmaceutical manufacturing facility OR Bachlors degree with 6+ years of aforementioned experience OR a High School Diploma with 8+ years of aforementioned experience.

Preferred Qualifications:
  • Have strong knowledge of GMP, SOPs and quality system processes and regulatory requirements.
  • Excellent organizational skills and ability to review processes or procedures.
  • Proficient in MS Word, Excel, Power Point, Adobe Pro, and electronic document management systems (Document Locator, Documentum, Veeva or equivalent).
  • Works on multiple assignments in collaboration with various department system owners.
  • Excellent interpersonal, verbal and written (including editing) communication skills are crucial in this collaborative work environment.
  • Ability to communicate and work independently with scientific/technical personnel.
  • Quality systems demonstrated working knowledge in areas such as document management, document change control, audits, archival, batch record and label issuance.
  • Comfortable in a fast-paced environment with minimal direction and able to adjust workload based upon changing priorities.
  • Do you have working knowledge of quality systems and regulatory requirements (21 CRF Part 11/210/211)? Please be sure to include it!


If this sounds like you, please apply today!

#IND123

Kite is a biopharmaceutical company engaged in the development of innovative cancer immunotherapies with a goal of providing rapid, long-term durable response and eliminating the burden of chronic care. The company is focused on chimeric antigen receptor (CAR) and T cell receptor (TCR) engineered cell therapies designed to empower the immune system's ability to recognize and kill tumors. Kite is based in Santa Monica, CA. For more information on Kite, please visit www.kitepharma.com. Sign up to follow @KitePharma on Twitter at www.twitter.com/kitepharma.

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 contactcareers@gilead.comfor 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 Kite Pharma Employees and Contractors:

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