Unfortunately, this job posting is expired.
Don't worry, we can still help! Below, please find related information to help you with your job search.
Don't worry, we can still help! Below, please find related information to help you with your job search.
Related keywords
- Quality Assurance Specialist
- Specialist Quality Assurance
- Senior Financial Quality Assurance Specialist
- Senior Quality Assurance Specialist
- Quality Assurance Senior Manager
- Senior Director Quality Assurance
- Quality Assurance Senior Specialist
- Senior Quality Assurance Associate
- Senior Quality Assurance Administrator
- Global Senior Quality Assurance Specialist
Some similar recruitments
Senior Specialist, Quality Assurance Investigations
Recruited by Bristol Myers Squibb 9 months ago
Address Devens, MA, United States
Quality Assurance Specialist Jobs
Recruited by Sanofi 9 months ago
Address Framingham, MA, United States
Senior Quality Specialist Jobs
Recruited by Agenus 9 months ago
Address Lexington, MA, United States
Specialist, Quality Assurance Jobs
Recruited by Moderna 9 months ago
Address Norwood, MA, United States
Specialist, Quality Assurance Jobs
Recruited by Moderna 9 months ago
Address Burlington, MA, United States
Quality Assurance Specialist Jobs
Recruited by SPECTRAFORCE 9 months ago
Address Ayer, MA, United States
Senior Quality Assurance Engineer
Recruited by State Street 9 months ago
Address Quincy, MA, United States
Quality Assurance Specialist Jobs
Recruited by Integrated Resources, Inc ( IRI ) 10 months ago
Address Massachusetts, United States
Test Publishing Administrator - Quality Assurance (Qa)
Recruited by Pearson 10 months ago
Address Hadley, MA, United States
Interim Senior Director, Quality Management – Immediate Hiring
Recruited by InfiCare Staffing 10 months ago
Address Canton, MA, United States
Director, Quality Assurance Technology Vendor Management
Recruited by Vertex Pharmaceuticals 10 months ago
Address Boston, MA, United States
Director Of Quality Assurance
Recruited by Allurion Technologies 11 months ago
Address Natick, MA, United States
Senior Manager, Clinical Quality Assurance
Recruited by CRISPR Therapeutics 11 months ago
Address Boston, MA, United States
Quality Assurance Specialist Jobs
Recruited by Battelle 11 months ago
Address Norwell, MA, United States
Quality Assurance Specialist Jobs
Recruited by AllSTEM Connections 11 months ago
Address Burlington, MA, United States
Quality Assurance Specialist With Documentation Experience
Recruited by Synectics Inc. 11 months ago
Address Groton, MA, United States
Quality Assurance Specialist Jobs
Recruited by On-Board Companies 11 months ago
Address Worcester County, MA, United States
Quality Assurance Specialist – 1St Shift
Recruited by Avantor 1 year ago
Address Ayer, MA, United States
Director Quality Assurance, Medical Device
Recruited by Shepherd Regulatory Search 1 year ago
Address Massachusetts, United States
Quality Assurance Associate Jobs
Recruited by Mastech Digital 1 year ago
Address Marlborough, MA, United States
Sr. Director, Gmp Quality Assurance Operations
Recruited by Moderna 1 year ago
Address Norwood, MA, United States
Sr. Director/ Vp, Quality Assurance
Recruited by Rapport Therapeutics 1 year ago
Address Boston, MA, United States
Senior Quality Assurance Specialist
Company | CRISPR Therapeutics |
Address | Framingham, MA, United States |
Employment type | FULL_TIME |
Salary | |
Category | Biotechnology Research |
Expires | 2023-07-02 |
Posted at | 11 months ago |
Company Overview
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
To view our Privacy Statement, please click the following link: http://www.crisprtx.com/about-us/privacy-policy
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
- Gathering, preparing, and reporting relevant Quality Metrics.
- Acting as QA support for deviation investigation activities related to GxP manufacturing and testing.
- Reviewing and approving; Deviations, Corrective and Preventative Actions (CAPAs), Change Controls, and Laboratory Investigations.
- Serving as a QA subject matter expert on process improvement initiatives to reduce deviations.
- Ensuring CRISPR’s QMS records are maintained in a state of inspection readiness.
- Participating in internal audits and regulatory inspections.
- Participating in risk assessments and root cause analysis.
- Performing gap analyses on processes, systems, and practices and recommending and implementing corrective actions and improvements.
- Collaborating with key internal partners including Quality, Manufacturing, Facilities, Quality Control, and Supply Chain.
- Drafting and revising controlled documents such as policies, processes, and procedures associated with the Quality Management System (QMS).
- Excellent written and verbal communication skills with the ability to communicate cross-functionally.
- 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.
- 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
- Innovation and strategic compliance skills including identification and implementation of best practices.
- Knowledge of FDA/EMA/ICH regulations and guidelines regarding compliance requirements
- Ability to organize and prioritize workload to meet deadlines and company’s objectives.
- Ability to work independently and within cross-functional teams.
- Demonstrated ability to inspire others and mentor team members.
- Operations experience in GxP Manufacturing or Quality Control.
- Prior experience working in compliance for cell or gene therapy manufacturing.
- Undaunted – Fearless, Can-do attitude
- Entrepreneurial Spirit – Proactive. Ownership mindset.
- Collaborative – Openness, One Team
- Results Orientation – Delivering progress toward our mission. Sense of urgency in solving problems.
To view our Privacy Statement, please click the following link: http://www.crisprtx.com/about-us/privacy-policy
-
Systems Analyst - Excel, Xml, Sql, Scripting
By CyberCoders At Salt Lake City, UT, United States 8 months ago
-
(Senior) Finance & Shared Services Manager
By Catholics For Choice At Washington, DC, United States 8 months ago
-
Paralegal - Probate Administration
By CyberCoders At Miami, FL, United States 8 months ago
-
Account Executive - Automotive Software
By ECW Search At United States 8 months ago
-
Construction Project Coordinator Jobs
By CyberCoders At River Falls, WI, United States 8 months ago