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QA Validation Coordinator
Columbus, OH, US
Scientific
Bachelors Degree
Full Time, Temporary
$35/hr.
Experienced (Non-Manager)
On-site
Biotechnology/Pharmaceuticals
First Shift (Day)
Columbus, OH, US
$35/hr.
Experienced (Non-Manager)
Full Time, Temporary
Biotechnology/Pharmaceuticals
On-site
Scientific
Bachelors Degree
First Shift (Day)
Job details
Kelly Scientific is searching for a skilled QA Validation Coordinator to support a biopharma customer advancing novel gene therapies from concept to commercialization. Located in the heart of Columbus, OH and 100% onsite.
Job Title: Quality Assurance Validation Coordinator
Location: Columbus, OH
Rate: $35/hr.
Shift: 8am-4:30pm | Mon-Fri
Length of Assignment: 6 months
The Quality Assurance Specialist Validation Coordinator is responsible for managing validations related to manufacturing product, process, equipment, laboratory and facility, contributing to the oversight of key strategic, tactical, and operational aspects within Quality Assurance.
In this critical QA role, you will lead as a Subject Matter Expert in a newly formed quality assurance team with a primary focus on Phase 3.
- Review/Manage equipment, process, and test method validations and Quality review and approval associated activities for a newly constructed cell and gene therapy CDMO facility.
- Support Regulatory Agency submissions and audits by being a Subject Matter Expert in the assigned area.
- Review and audit complex documents: batch records, GMP protocols, process and method validations in compliance with QMS, policies, and procedures.
- Observe manufacturing activities to support the implementation of best practices and improvements, including the transfer of site knowledge to new facility startup activities.
- Support technology transfer initiatives, as assigned.
- Manage QMS; author, review, and approve SOPs and Policies for the new facility.
- Prepare routine updates and project status reports of Quality Assurance activities.
- Provide oversight and input to Trend Review Reporting and Lifecycle Review activities to identify and address process shifts and trends.
- Ensure that documentation is maintained in accordance with internal procedures and regulatory requirements.
- Support, prepare, and provide Quality training with cross-functional teams as assigned.
Requirements:
- Minimum of 2-3 years experience GMP/Biopharmaceutical/Biotech Industry/FDA
- QA hands-on experience in a pharmaceutical or cell and gene therapy environment preferred.
- Bachelor’s Degree in a technical or scientific discipline or equivalent
- Operational knowledge of cGMP regulations and guidelines including but not limited to U.S. Code of Federal Regulations 21 CFR Part 11 and Part 210 & 211
- Demonstrated Project Management abilities to lead and manage several projects, meeting deadlines, and use critical thinking skills to problem solve effectively.
- Excellent verbal and written communication skills at all levels of the organization.
- Technical writing is required.
- Experience with FDA, and EMA inspection interaction.
- Strong experience working in cross-functional teams.
- Ability to influence, negotiate, manage conflict, and collaborate.
- Must demonstrate a “can-do” attitude.
- Proficient using Microsoft applications (Word, Excel, PowerPoint).
- Knowledge of application software such as Trackwise, and SAP, preferred.
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