Senior QA Documentation Control Specialist

Company: Caribou Biosciences, Inc.
Location: Berkeley
Posted on: January 27, 2023

Job Description:

Caribou is a leading clinical-stage CRISPR genome-editing biopharmaceutical company founded by pioneers in this field. Leveraging our proprietary technologies, we are developing genome-edited, off-the-shelf immune cell therapies for the treatment of patients with devastating human diseases, including cancer. We believe that cell therapies are critical now and for the future of cancer therapeutics, and that advanced genome editing is necessary to develop sophisticated cell therapies to treat a variety of malignancies. We are developing a pipeline of wholly-owned, genome-edited, off-the-shelf CAR-T and CAR-NK cell therapy product candidates for a range of tumor types. Caribous headquarters are in Berkeley, California.



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 an articulate and motivated Senior QA Documentation Control Specialist to join our Regulatory Affairs & Quality Assurance 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 organization, along with Contract Development Manufacturing Organizations (CDMOs), CROs, and other vendors. This position reports to the Manager, Quality Assurance GMP, and is a great opportunity to be part of the mission to save the lives of patients.

Responsibilities 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

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

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/MS degree in Biology, Chemical Engineering, Chemistry, or similar

Minimum 8+ years of experience in QA documentation in a pharmaceutical or Biotechnology environment.

Experience with electronic quality management systems (eQMS) is required

Proficiency with MS office (Excel, Word, PowerPoint, Visio)

Excellent verbal and written communication skills

Experience in cGMP clinical and/or commercial is required

Great understanding of US regulatory requirements

Strong work ethic (self-motivated) and with attention to detail

Self-reliant, a good problem solver, and result oriented

Excellent collaboration with cross functional teams

Desire to work with a diverse team in a fast-paced environment under challenging timelines

Nice-to-haves:

Experience with Veeva EDMS systems

Understanding of EU GMP regulatory requirements

Caribou compensation and benefits include:Salary range: $95,000 to $123,000. This represents the present low and high end of the Companys pay range for this position. Actual pay will vary based on various factors, including but not limited to location, skill, experience, and performance.

Comprehensive compensation package, which includes stock options and an employee stock purchase program for all employees

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.



Caribou requires employees to be fully vaccinated against COVID-19 unless they have an approved medical or religious accommodation. Proof of such vaccination will be required as part of the hiring process.



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

Keywords: Caribou Biosciences, Inc., Berkeley , Senior QA Documentation Control Specialist, Other , Berkeley, California