Experience Inc. Jobs

Document Control Specialist

Type: 6-month temporary with possibility of extension

Shift: Monday – Friday, 8 AM – 5 PM

Onsite: San Carlos, California 94070

Pay: $25 - $30

Overview:

Kelly Science and Clinical is hiring a temporary Document Control Specialist. This role is crucial in providing day-to-day support for the development, revision, and issuance of GxP documentation and recordkeeping. This role will adhere to established SOPs, work instructions, and templates to facilitate compliant program management and support the ongoing GxP Documentation needs of Tech Ops.

Responsibilities :

• Perform Document controller activities in Veeva for all GMP controlled documentation, including policies, SOPs, and protocols, in alignment with established procedures.

• Review, format, and approve manufacturing and quality records that support GMP operations in accordance with internal procedures.

• Handle control, issuance, reconciliation, and archiving of GMP manufacturing and testing documentation, including batch manufacturing records and logbooks.

• Ensure alignment to internal requirements while working in the Veeva QualityDocs system.

• Support Quality and the broader Tech Ops team with any other GxP documentation requirements as needed.

• Respond to requests from Tech Ops personnel to support the creation, revision, and/or obsolescence of GxP documents.

• Act as the Veeva QualityDocs document controller, supporting ongoing implementation and configuration of EDMS in alignment with CARGO business requirements.

Requirements:

• Degree in technology or life sciences with 2 years of relevant experience in the biotech or cell and gene therapy industry.

• Experience working with Veeva Quality Vault.

• Experience working with validated, GxP Document Management systems and interacting with vendors (e.g., Veeva).

• Excellent command of MS Word and advanced features, plus the suite of Microsoft applications.

• Understanding of document lifecycle management and application to internal processes.

• Excellent knowledge of data integrity principles and their application in document management.

• Knowledge of basic GMPs and regulatory requirements applicable to cell and gene therapy and/or biologics.

Preferred Requirements:

• Working knowledge of ICH guidance, regulatory guidance, and pharmaceutical organization guidance.

• Strong familiarity working in support of biologics or cell/gene therapy manufacturing process and technology.

As part of our promise to talent, Kelly supports those who work with us through a variety of benefits, perks, and work-related resources. Kelly offers eligible employees voluntary benefit plans including medical, dental, vision, telemedicine, term life, whole life, accident insurance, critical illness, a legal plan, and short-term disability. As a Kelly employee, you will have access to a retirement savings plan, service bonus and holiday pay plans (earn up to eight paid holidays per benefit year), and a transit spending account. In addition, employees are entitled to earn paid sick leave under the applicable state or local plan. Click here (https://www.mykelly.com/help-support-working-with-kelly-us/#Benefits) for more information on benefits and perks that may be available to you as a member of the Kelly Talent Community.

Why Kelly ® Science & Clinical?

Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire industry experts just like you. Our team creates expert talent solutions to solve the world’s most critical challenges. Every day, we match science professionals with dream jobs that fit their skills, interests, and career goals—it’s the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background and education in science, so we know a thing or two about the science market and how to get your expertise noticed.

About Kelly

Work changes everything. And at Kelly, we’re obsessed with where it can take you. To us, it’s about more than simply accepting your next job opportunity. It’s the fuel that powers every next step of your life. It’s the ripple effect that changes and improves everything for your family, your community, and the world. Which is why, here at Kelly, we are dedicated to providing you with limitless opportunities to enrich your life—just ask the 300,000 people we employ each year.

Kelly Services is proud to be an Equal Employment Opportunity and Affirmative Action employer. We welcome, value, and embrace diversity at all levels and are committed to building a team that is inclusive of a variety of backgrounds, communities, perspectives, and abilities. At Kelly, we believe that the more inclusive we are, the better services we can provide. Requests for accommodation related to our application process can be directed to Kelly’s Human Resource Knowledge Center. Kelly complies with the requirements of California’s state and local Fair Chance laws. A conviction does not automatically bar individuals from employment. Kelly participates in E-Verify and will provide the federal government with your Form I-9 information to confirm that you are authorized to work in the U.S.

Kelly Services is proud to be an Equal Employment Opportunity and Affirmative Action employer. We welcome, value, and embrace diversity at all levels and are committed to building a team that is inclusive of a variety of backgrounds, communities, perspectives, and abilities. At Kelly, we believe that the more inclusive we are, the better services we can provide. Requests for accommodation related to our application process can be directed to Kelly’s Human Resource Knowledge Center. Kelly complies with the requirements of California’s state and local Fair Chance laws. A conviction does not automatically bar individuals from employment.