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Job Information

Gilead Sciences, Inc. Quality Control Specialist I (KLIMS), Analytical Operations in Frederick, Maryland

For Current Kite Pharma Employees and Contractors:

Please log onto your Internal Career Site (https://www.myworkday.com/gilead/d/inst/13102!CK5mGhIKBggDEMenAhIICgYI1A0QtgI/cacheable-task/2997$2151.htmld#backheader=true) to apply for this job.

Job Description

As a KITE Laboratory Information Management System (KLIMS) Specialist in the Quality Control (QC) Technical Services group, this role will act as one of local KLIMS site support and as a LIMS Administrator back-up for KLIMS related topics to the larger organization. The QC KLIMS Specialist will support both site and global programs priorities to achieve established system functionality goals, in addition to supporting any interactions and communications between site cross-functional personnel (QC, Quality Assurance, Manufacturing, F&E, IT, etc.) and the global program team, as needed.

Overall, this role is responsible for providing the technical support and expertise necessary to build and/or manage maintenance of established Master Data, implementation of new system functionality of the Global LabVantage LIMS system at the site.

Responsibilities

Site Related:

  • Site KLIMS supports system function and use at site:

  • Support and resolve KLIMS issues that impact current operations.

  • Support weekly reagent updates (from ERP for released materials).

  • Support training and use of KLIMS for each function at the site.

  • Generation of site-specific Master Data to support KLIMS functionality rollout at site.

  • Implement Master Data updates/changes related to the site as they arise.

  • Participate in KLIMS maintenance and system upgrade activities.

  • Collect improvement opportunities and associated requirements from the business and escalate to the appropriate global working team.

  • Supports site specific KLIMS project deliverables (e.g. vertical/functionality delivery)

  • Support best practices on LIMS development, Master data, reporting, and any other configuration.

  • Troubleshoot site related KLIMS issues and escalate to the global team, as necessary.

  • Assist in developing, reviewing, and maintaining site specific, KLIMS related documentation (i.e. SOPs, SPCs, WRKs, URSs).

  • Assist with deviation, investigation, impact assessments, CAPA and change control activities.

  • Support inspections/audits for KLIMS specific topics, requests, or questions.

  • Additional duties as assigned.

Global Related:

  • Participates in global, vertical specific, working and delivery teams.

  • Provide peer review support of Master Data updates generated by other QC KLIMS Admins and backup support for other sites as needed.

  • Review and update local and global SOPs and WRKs related to LIMS, as required.

  • Additional duties as assigned.

Basic Qualifications:

  • Master’s and 2+ years of experience in a GMP environment, OR;

  • Bachelor’s and 4+ years of experience in a GMP environment, OR;

  • Associate and 5+ years of experience in a GMP environment, OR;

  • High School Diploma/GED and 6+ years experience in a GMP environment experience.

Preferred Qualifications:

  • Experience with a Lab Information Management System preferably LabVantage (otherwise Sample Manager, LabWare, StarLIMS or similar).

  • Demonstrated results implementing LIMS and computer system validation in a cGMP environment.

  • Experience in areas such as sampling, pharmaceutical quality control lab, laboratory data and reports (C of C, C of A), data management, change control, GLP/GMP and compliance.

  • General understanding of pharmaceutical GMPs and 21CFR Part 11 regulations.

  • Excellent technical writing experience in a regulatory environment such as protocols, reports, and SOPs.

  • Ability work independently, and/or as part of a team with internal and external teams.

  • Ability to learn new techniques, perform multiple tasks simultaneously, keep accurate records, follow instructions, and comply with company policies.

  • Excellent skills in Microsoft Office, MS Project, MS Teams, SharePoint, Smartsheets, data analysis software, and other related applications.

  • Excellent interpersonal, verbal and written communication skills are essential in this collaborative work environment.

  • Comfortable in an exciting small company environment with minimal direction and able to adjust workload based upon changing priorities.

Does this sound like you? If so apply today!

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The salary range for this position is: $78,455.00 - $101,530.00. Kite considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. These considerations mean actual compensation will vary. This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary based on role), paid time off, and a benefits package. Benefits include company-sponsored medical, dental, vision, and life insurance plans*.

For additional benefits information, visit:

https://www.gilead.com/careers/compensation-benefits-and-wellbeing

  • Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans.

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 contact ApplicantAccommodations@gilead.com for assistance.

For more information about equal employment opportunity protections, please view the 'Know Your Rights' (https://www.eeoc.gov/employers/eeo-law-poster) poster.

NOTICE: EMPLOYEE POLYGRAPH PROTECTION ACT (http://www.dol.gov/whd/regs/compliance/posters/eppac.pdf)

YOUR RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE ACT

PAY TRANSPARENCY NONDISCRIMINATION PROVISION (https://www.dol.gov/sites/dolgov/files/OFCCP/pdf/pay-transp_%20English_formattedESQA508c.pdf)

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 (https://www.myworkday.com/gilead/d/inst/13102!CK5mGhIKBggDEMenAhIICgYI1A0QtgI/cacheable-task/2997$2151.htmld#backheader=true) to apply for this job.

Change The World With Us

Everyone at Kite is grounded by one common goal – curing cancer. Every day, we aim to establish a direct line between that purpose and our day-to-day work.

We are creating Kite together, with the recognition that the best teams are built by the best people. We maintain an attitude of curiosity, and creativity with each challenge as we develop a new market for cancer therapies. We appreciate and respect one another, and most importantly, we don’t take success for granted.

While we’ve come a long way to make what others viewed as impossible, possible, we know one thing is certain. Today is just the beginning.

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