QA Documentation Specialist

175 - Quality Assurance · Berkeley, California
Department 175 - Quality Assurance
Employment Type Full-Time
Minimum Experience Mid-level

Caribou Biosciences is a clinical-stage biopharmaceutical company founded in 2011 by pioneers in CRISPR genome editing and headquartered in Berkeley, California. The company’s mission is to develop innovative, transformative therapies for patients with devastating diseases through novel genome editing. Caribou leverages its proprietary technologies to develop a wholly owned pipeline of genome-edited, off-the-shelf immune cell therapies, including CAR-Ts and CAR-NKs, for the treatment of multiple different types of cancer. Caribou believes that advanced genome editing is necessary to develop sophisticated cell therapies to treat a variety of malignancies.

 

Members of the Caribou herd open their minds to new ideas and welcome diverse perspectives. We proudly assert that teams do their best work when their members are personally engaged, their ideas are taken seriously, their contributions are recognized, and their needs are met

 

We are seeking a QA Documentation Control Specialist to join our team. In this role, you will support QA activities ensuring compliance to SOPs and other controlled documents. You will work cross-functionally with teams across the company, along with Contract Development Manufacturing Organizations (CDMOs), CROs, and other vendors. This position reports to the Director of Quality Assurance.

 

Responsibilities will include:

  • Manage GxP controlled documents, which includes but is not limited to SOPs, Process Records, Work Instructions, Forms, Templates, Batch Records, and Test Records
  • Manage documentation collaboration, formatting, numbering system, issuance, and archive
  • Process requests for document change control through the DCC process
  • Manage the Veeva Electronic Document Management System (EDMS) to support paperless document management and training
  • Act as a QA SME to provide ongoing support for functional teams for Veeva EDMS
  • Manage the Training program and ensure all functional teams have an appropriate training curriculum (Employee Training Plan) in place
  • Provide quality training, which includes but not limited to new hire onboarding training, GMP annual training, and quality SOP training, as needed
  • Prepare and present training and documentation KPI, as applicable/required
  • Other duties as assigned

 

Candidate must possess:

  • Minimum 5+ years of a pharmaceutical/biotechnology experience
  • BS/MS degree in Biology, Chemical Engineering, or Chemistry
  • Experience in cGMP clinical and/or commercial is required
  • Previous experience with QA documentation and training is highly desired
  • Proficiency with MS office (Excel, Word, PowerPoint, Visio)
  • Experience with Veeva EDMS systems is preferred.
  • Great understanding of regulatory requirements with focus on US and EU
  • Strong work ethic (self-motivated)
  • Excellent collaboration with cross functional teams
  • Self-reliant, a good problem solver, and result oriented
  • Desire to work with a diverse team in a fast-paced environment under challenging timelines
  • Excellent verbal and written communication skills
  • Detail orientated

 

Caribou compensation and benefits include:

  • Comprehensive compensation package including stock options and employee stock purchase program
  • Generous paid vacation time in addition to Company-observed holidays and floating holidays
  • Excellent medical, dental, and vision insurance
  • 401(k) retirement savings plan including matching employer contributions
  • Tuition reimbursement program

 

Caribou is an equal opportunity employer and does not discriminate on the basis of race, color, religion, marital status, age, national origin, ancestry, physical or mental disability, medical conditions, veteran status, sexual orientation, gender (including gender identity and gender expression), sex (which includes pregnancy, childbirth, and breastfeeding), genetic information, taking or requesting statutorily protected leave, or any other basis protected by law. In addition, Caribou prohibits the harassment of any individual on any of the bases listed above or any other characteristics protected under federal, state, or local laws. Legal authorization to work in the United States is required. In compliance with federal law, all persons hired will be required to verify identity and eligibility to work in the United States and to complete the required employment eligibility verification form upon hire. 

 

Caribou is on Twitter. Follow the Company @CaribouBio.

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  • Location
    Berkeley, California
  • Department
    175 - Quality Assurance
  • Employment Type
    Full-Time
  • Minimum Experience
    Mid-level