Senior QA Documentation Associate

Caribou Biosciences is a leading clinical-stage CRISPR genome-editing biopharmaceutical company dedicated to developing transformative therapies for patients with devastating diseases. Our next-generation genome-editing technology enables superior precision to develop cell therapies that are armored to potentially improve antitumor activity. We believe the future of cell therapy is off-the-shelf, and we are advancing our pipeline of off-the-shelf, or allogeneic, cell therapies from our CAR-T and CAR-NK platforms as readily available treatments for patients with hematologic malignancies and solid tumors.

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, and contributions are recognized. Members of the herd work from our headquarters in Berkeley, California, or remotely.

We are seeking a motivated Senior QA Documentation Associate to join our Regulatory Affairs & Quality Assurance team.  In this role, you will support QA activities ensuring compliance with SOPs and other controlled documents. You will work cross-functionally with teams across the organization, along with Contract Development Manufacturing Organizations (CDMOs), CROs, and other vendors.  This is an exciting opportunity where you will be involved with building out quality systems for the Caribou organization!

Responsibilities will include:

• Manage GxP controlled documents, which includes but is not limited to SOPs, Process Records, Work Instructions, Forms, Templates, Policies, Batch Records, and Test Records
• Manage documentation collaboration, formatting, numbering system, issuance, and archive
• Route documents for signatures via DocuSign; this includes populating signature field and ensuring it is 21 CFR pt. 11 compliant for the signature requirements
• 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
• As system owner responsible for tracking and updating Learn GxP courses in Veeva EDMS
• Track and Manage Periodic Reviews of documents ensuring they are completed in a timely manner
• Act as a QA SME to provide ongoing support for functional teams for Veeva EDMS
• Lead efforts for document archiving ensuring that documents are housed in proper folders in Egnyte and, ultimately, assist in the transition to document archiving in Veeva
• Manage the Training program and ensure all functional teams have an appropriate training curriculum (Employee Training Plan) in place and is updated annually
• Manage and update the training curricula matrix
• Provide quality training, which includes but not limited to new hire onboarding training, GMP annual training, DocuSign training and quality SOP training, as needed
• Prepare and present training and documentation KPI, as applicable/required
• Other duties as assigned

Qualifications:

• BS degree in Biology, Chemical Engineering, Chemistry, or similar
• 5-7 years of experience in QA documentation in a pharmaceutical or biotechnology environment
• Experience with electronic quality management systems (eQMS); specifically, direct experience working with Veeva
• Minimum of 5 years’ experience working in a GMP environment
• Skilled in presenting with strong communication abilities
• Proficient in MS Office (Excel, Word, PowerPoint, Visio)
• Strong verbal and written communication skills
• Familiar with US regulatory requirements
• Highly diligent, self-motivated, and detail-oriented
• Self-reliant problem solver, results-driven
• Excel in collaborating with cross-functional teams
• Eager to work in a diverse, fast-paced environment with tight timelines
• Ability to work in a hybrid environment with remote and onsite requirements

Nice-to-haves:

• Experience working with SharePoint and/or Egnyte
• Experience with EU GMPs
• Prior experience working in a process/operational work within quality assurance

Caribou compensation and benefits include:

• Comprehensive compensation package, which includes stock options and an employee stock purchase program for all employees
• Salary Range: $77,000 – $98,000. This represents the present low and high end of the Company’s pay range for this position. Actual pay will vary based on various factors, including but not limited to location, skill, experience, and performance. 
• Generous paid vacation time, in addition to company-observed holidays and floating holidays
• Excellent medical, dental, and vision insurance
• 401(k) retirement savings plan, which includes matching employer contributions
• Tuition reimbursement program

The benefits and stock purchase described above are subject to the terms and conditions of any governing plans, policies, practices, agreements, or other materials or documents as in effect from time to time, including but not limited to terms and conditions regarding eligibility.

Caribou is an equal opportunity employer and does not discriminate based on 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. 

For more information about Caribou, visit www.cariboubio.com and follow the company @CaribouBio.