Crown Bioscience · 1 day ago
Quality Assurance Manager
Kannapolis, NC
Part-time
Onsite
Mid Level
4+ years expCrown Bioscience is a company focused on improving site performance through a robust quality management program. The Quality Assurance Manager will oversee the implementation of global initiatives, ensure compliance with regulations, and drive improvements in quality and efficiency across the site.
BiotechnologyHealth CareMedical
Responsibilities
Provide focus for the Quality Management System and work closely with all departments and functions to promote processes that ensure consistency, continuous improvement and compliance with quality and business requirements
Provide support for Quality Systems and maintain the appropriate level of customer service
Prepare, host, and respond to findings for external audits (e.g.: regulatory, ISO/CAP/CLIA, client, etc.)
Prepare non conformance reports and monitoring reporting performance and trends
Problem solve, identification of root cause and implementation/follow up of corrective procedures and preventive actions to ensure timely resolution of such problems
Ability to perform internal audits as required according to site and global plans
Use auditing as a proactive tool for improvement as well as compliance and challenge existing practice where appropriate
Timely completion and follow up through to closure of CAPA actions
Measuring and monitoring of performance against agreed KPIs
Collate and share information/data across the site as appropriate through reports and follows up on identified improvement opportunities
Actively contribute to the success of the overall QA team and the site
Responsible for ensuring the company and its quality management system (QMS) meets relevant regulations and standards (e.g., FDA, QSR, ISO standards, CLIA, CAP, GLP, GDP, EH&S) and other guidelines
Oversee supplier/vendor management, assuring that vendors are operating in compliance with the applicable quality program and regulations guidelines
Managed QA department and quality activities such as document control, training, calibration, complaints, incoming inspection, nonconformance, deviation, CAPA system, supplier management system, internal and external audits
Support site EHS program
Actively participate and/or drives EU/Global QMS improvements as required
Qualification
Required
Bachelor's degree in a scientific discipline
4-5 years of related quality assurance experience
Experience with GLP/GCLP/ ISO9001 is required
Ability to work in an in-vivo laboratory environment is required
Able to make competent decisions based on a review of analytical data
Able to write clear, coherent internal business communications / reports and presents results of work
Willing and able to work under the pressure of deadlines and find solutions to meet timelines
Ability to work across teams by being a flexible team player with strong communication and interpersonal skills
Comfortable using computers, including a working knowledge of Microsoft Office programs, e-mail, and internet
Exceptional organizational and time-management skills. Ability to multi-task with a high degree of professionalism and diplomacy
Preferred
Experience in the life sciences industry is preferred
Experience with EHS programs is preferred
Company
Crown Bioscience
CrownBio is helping provide clarity of action in the fight against cancer and diabetes.
1001-5000 employees
H1B Sponsorship
Crown Bioscience has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (3)
2024 (2)
2023 (2)
2021 (2)
2020 (1)
Funding
Current Stage
Late StageTotal Funding
$61.1MKey Investors
Lilly Asia VenturesQiming Venture Partners
2025-11-13Acquired
2014-05-23Series D· $26.6M
2011-05-04Series C· $28.8M
Leadership Team
Keefe Chng
Executive Director, Chief Scientific Officer
Recent News
2025-11-24
globallegalchronicle.com
2025-11-20
Company data provided by crunchbase