Senior QA Documentation Control Specialist
Company: Caribou Biosciences, Inc.
Location: Berkeley
Posted on: January 27, 2023
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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
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