CRISPR Therapeutics is a leading gene editing company focused on developing transformative gene-based medicines for serious diseases using its proprietary CRISPR/Cas9 platform. CRISPR/Cas9 is a revolutionary gene editing technology that allows for precise, directed changes to genomic DNA. CRISPR Therapeutics has established a portfolio of therapeutic programs across a broad range of disease areas including hemoglobinopathies, oncology, regenerative medicine and rare diseases. To accelerate and expand its efforts, CRISPR Therapeutics has established strategic partnerships with leading companies including Bayer, Vertex Pharmaceuticals and ViaCyte, Inc. CRISPR Therapeutics AG is headquartered in Zug, Switzerland, with its wholly-owned U.S. subsidiary, CRISPR Therapeutics, Inc., and R&D operations in Boston, Massachusetts and San Francisco, California, and business offices in London, United Kingdom.
Position Summary
Reporting to the Senior Manager, Quality Engineering, the Senior Quality Assurance Specialist is responsible for providing QA oversight, review and approval for deviation, corrective and preventive action, and change control processes at CRISPR's internal manufacturing facility in Framingham MA.
Responsibilities
Acting as QA support for deviation investigation activities related to GxP manufacturing and testing.
Participating in risk assessments and root cause analysis.
Reviewing and approving; Deviations, Corrective and Preventative Actions (CAPAs), Change Controls, and Laboratory Investigations.
Drafting and revising controlled documents such as policies, processes, and procedures associated with the Quality Management System (QMS).
Serving as a QA subject matter expert on process improvement initiatives to reduce deviations.
Performing gap analyses on processes, systems, and practices and recommending and implementing corrective actions and improvements.
Ensuring CRISPR's QMS records are maintained in a state of inspection readiness.
Participating in internal audits and regulatory inspections.
Gathering, preparing, and reporting relevant Quality Metrics.
Collaborating with key internal partners including Quality, Manufacturing, Facilities, Quality Control, and Supply Chain.
Minimum Qualifications
Bachelor's degree in an Engineering or related field with 5+ years of experience in compliance of a GxP regulated environment or a Master's Degree with 3+ years of experience
Subject Matter Expert in deviation investigation, corrective action and change control required.
Experience working with electronic system(s) to ensure compliance in 21CFR Part 11 and other applicable regulations.
Excellent written and verbal communication skills with the ability to communicate cross-functionally.
Demonstrated ability to inspire others and mentor team members.
Innovation 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.
Knowledge of FDA/EMA/ICH regulations and guidelines regarding compliance requirements
Preferred Qualifications
Prior experience working in compliance for cell or gene therapy manufacturing.
Operations experience in GxP Manufacturing or Quality Control.
Competencies
Collaborative - Openness, One Team
Undaunted - Fearless, Can-do attitude
Results Orientation - Delivering progress toward our mission. Sense of urgency in solving problems.
CRISPR Therapeutics, Inc. is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law.
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