Job description
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 activity against diseases. 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 cell therapy platform as readily available treatments for patients with hematologic malignancies and autoimmune diseases.
Summary of the role:
The Quality Assurance Operations Specialist will be supporting QA Operations for Caribou’s CDMO cell therapy manufacturing facilities. This role will provide front line QA support for production operations including manufacturing and associated quality control, requiring strong GMP and adept at related QMS (Investigations, change controls, risk management), problem-solving skills, prior hands-on experience in QC or manufacturing, and an agile, continuous improvement mindset. This role is temporary for up to 12 months and will be expected to come onsite in Berkeley regularly depending on management/business needs
Responsibilities:
- Support lot disposition activities, including comprehensive review of executed batch records, QC test records, , CoCs, CoAs, validation reports, pharmacy manuals, shipping documents, environmental monitoring data and other critical release documents with a focus on data integrity, traceability, and compliance. Ensure all materials meet internal and regulatory standards prior to QA disposition.
- Serve as front-line QA support for Manufacturing, QC, and Facilities by triaging manufacturing and testing issues, performing real-time impact assessments, and executing or recommending immediate corrective actions.
- Escalate significant quality concerns, including critical deviations—in a timely and structured manner to QA leadership.
- Collaborate with internal teams and the CDMOs/CTLs to address observations, deviations, or missing data during document reviews; ensure issues are resolved and escalated to QA management as appropriate.
- Act as QA partner on change controls, deviations, non-conformances, OOS investigations, and CAPAs, ensuring quality system processes are followed and documentation is complete and audit ready.
- Coordinate and support internal and external audits, including investigator site audits, vendor audits, and for-cause assessments. Support audit logistics, reporting, and CAPA implementation tracking.
- Draft, review, and approve controlled documents such as SOPs, guidance documents, and training materials to ensure procedural alignment with current practices and regulatory expectations.
- Maintain and update QA metric tracking tools to support continuous improvement and visibility into quality system performance. Be proficient in Microsoft Excel, including advanced functions such as pivot tables, formulas, conditional formatting, and lookup functions to organize, analyze, and extract trends from QA data. Converting data into graphs/charts for presentation purposes.
- Facilitate QA training and onboarding for new employees and promote a culture of GMP and GDP compliance throughout the organization.
- Represent QA in cross-functional project teams, regulatory review submission activities, and interactions with CDMO partners, providing timely guidance on compliance expectations and best practices.
- Identify quality trends, recurring issues, and improvement opportunities; partner with QA leadership to develop and implement continuous improvement initiatives.
- Schedule and document QA meetings, including agendas, action logs, and minutes, ensuring follow-up on key items.
- Serve as a role model of professionalism, collaboration, and problem-solving, with strong written and verbal communication skills.
- Perform other duties as assigned by management.
Qualifications:
- BS degree in the life sciences or related discipline with a minimum of 5 years’ experience in QA, QC, or Manufacturing in an FDA-regulated industry, preferably biologic therapeutics
- Excellent organizational, prioritization and planning skills in a fast-paced team-oriented environment
- Ability to work independently on multiple projects internally and with external vendors
- Possess a sense of urgency; identify challenges and problems and take the initiative to identify solutions
- Competence in cGMP requirements
- Experience in Cell and Gene Therapy, CDMOs, Qualification/Validation; Veeva Quality Suite is a plus
- Excellent verbal and written communication skills
- Strong interpersonal skills; able to interact effectively with a variety of internal and external personnel
- Proficient in MS Office applications
Nice-to-haves:
- Experience in a start-up/early-phase development environment
- Experience with pre-commercial product launch activities including review of BLA or MAA
- Knowledge of current best practices for analytical assays for cellular therapies
- Background in immuno-oncology or cell engineering
This position is for a temporary or contract employee who will not be directly employed by Caribou Biosciences. Instead, the individual will be an employee of a third-party staffing firm, and their work activities will be managed by the Caribou team. As a temporary/contract employee, you will collaborate closely with Caribou’s internal teams and contribute to our mission while reporting and getting supported by the staffing firm.
We do not accept unsolicited resumes or candidate submissions from staffing agencies. All agencies must have a valid written agreement with Caribou Biosciences, Inc.for service in place. Any resume or candidate submitted by a staffing agency without such an agreement in place will be considered unsolicited, and Caribou Biosciences, Inc. will not be obligated to pay any referral or placement fee.
