Senior Specialist, QA Operations

Company Overview

Since its inception over a decade ago, CRISPR Therapeutics has transformed from a research-stage company advancing programs in the field of gene editing, to a company with a diverse portfolio of product candidates across a broad range of disease areas including hemoglobinopathies, oncology, regenerative medicine, cardiovascular and rare diseases. The Nobel Prize-winning CRISPR science has revolutionized biomedical research and represents a powerful, clinically validated approach with the potential to create a new class of potentially transformative medicines. To accelerate and expand its efforts, CRISPR Therapeutics has established strategic partnerships with leading companies including Bayer and Vertex Pharmaceuticals. CRISPR Therapeutics AG is headquartered in Zug, Switzerland, with its wholly-owned U.S. subsidiary, CRISPR Therapeutics, Inc., and R&D operations based in Boston, Massachusetts and San Francisco, California, and business offices in London, United Kingdom.

Position Summary

Reporting to the Associate Director Quality Operations, the Senior Specialist is responsible for supporting ongoing GMP operations throughout the facility. Some roles to highlight that are covered under this responsibility are Warehouse support and raw material disposition, Manufacturing record review and floor support, Drug Product disposition and shipment.

Responsibilities

• Supporting routine Warehouse activities including raw material release, receipt of critical materials, and cold storage movements.
• Assisting the Manufacturing team in completing routine processes such as cleaning / equipment logbook review, batch record approval, vial inspection, and maintenance events occurring within the controlled areas.
• Approval of Equipment and Facility lifecycle and maintenance documentation within the Blue Mountain System. Some of this work includes discussions around Preventative Maintenance schedules, Unplanned events within the facility, and Facility shutdown planning and oversight.
• Acting as a QA SME in supporting the development and implementation of processes aimed to support compliant, robust, and sustainable operations for; facilities/utilities and equipment, warehouse logistics, shipping, manufacturing, cleaning, and process.
• Author/maintain team SOPs and related documents to ensure compliant processes are continuous within the department.
• Lead the implementation of QA Operations strategies and act as SME to support other departments’ efforts on site.
• Utilize the QMS system to manage deviations, change controls, and CAPAs.
• Intake of potential deviation events and assisting in their mitigation from departments supported by this team.
• Supporting supplier qualification efforts
• Participating in internal audits and regulatory inspections.
• Gathering, preparing, and reporting relevant Quality Metrics.
• Work with key internal partners including Quality Assurance, Manufacturing, Facilities, Quality Control, MSAT and Supply Chain.

Minimum Qualifications

• BS with 5-7+ years of experience or an advance degree with 4-6+ years of experience QA operations, cell therapy GMP manufacturing / supply chain, or compliance in a highly regulated GMP environment.
• Experience in the development, execution, and approval of SOPs and batch records.
• Experience in raw material receipt, disposition, and warehouse operations
• Proficiency working within a GMP warehouse or similar environment.
• Experience with gowning into a Grade B cleanroom and knowledge of proper etiquette when working within one.
• Experience with the use of electronic system(s) to ensure compliance.
• Excellent written and verbal communication skills with the ability to communicate cross-functionally.
• Innovative and strategic compliance skills including identification and implementation of best practices.
• Ability to organize and prioritize workload to meet deadlines and company’s objectives.
• Ability to work independently and within cross-functional teams.
• Ability to mentor less experienced staff members.

Preferred Qualifications

• Prior experience working in cell or gene therapy.

Competencies

• Collaborative – Openness, One Team
• Undaunted – Fearless, Can-do attitude
• Results Orientation – Delivering progress toward our mission. Sense of urgency in solving problems.
• Entrepreneurial Spirit – Proactive. Ownership mindset.