What are the responsibilities and job description for the Manufacturing Quality Specialist position at Kymanox?
Description
I s Kymanox the right fit for you?
You want to make a difference and have an impact...
You enjoy having an influence in your day-to-day work...
You are motivated by working alongside a team filled with
subject matter experts who will help you learn and grow...
You wake up every day and do what you do
because patients deserve better.
If this sounds like you, you've come to the right place.
The Manufacturing Quality Specialist will join our Quality Assurance and Compliance team and play a key role in providing quality support for the King of Prussia small-scale device manufacturing facility and process development. The specialist would also support Kymanox's clients with compliance activities, with an emphasis on quality oversight of contract manufacturers and batch production, gap assessments, and phase-appropriate quality management system implementation.
Responsibilities :
- Quality support of daily operations of early-phase or design phase device subassembly manufacturing and may support the device design or verification testing services at the King of Prussia location.
- Quality support for manufacturing materials including review and disposition of incoming materials and finished goods.
- Quality review of technical documentation, (e.g., batch records, design history files), QC data, and supporting documentation.
- Quality management system element support (e.g. deviations, nonconforming products, corrective and preventive actions, complaints, change management, supplier management).
- Quality support of client audits at KOP site.
- Supplier management activities, including onboarding and maintaining supplier qualifications.
- Gap assessments against industry regulations or standards and remediation support.
- Design and implementation of Quality Management Systems. Development of policies or standard operating procedures and training (internal and external).
Educational Background :
Experience :
Desired Aptitude and Skill Set :
Travel :
Travel may be required, up to 10%
Career Development :
The position will evolve over time and more responsibilities may be added. Since Kymanox is a growing company, there are opportunities for advancement both within the currently defined role and in other functions within the organization.
Compensation :
Base salary is commensurate with experience, qualifications, and other intangibles evident during the interview process - as well as market conditions. Eligible for incentive program after 90 days of outstanding work.
Benefits :
Medical healthcare including dental and vision, short- and long-term disability, life insurance, matching 401(k) retirement plan, continuing education assistance, and other benefits.
About Kymanox :
Join Kymanox - a life sciences professional services company dedicated to life sciences who has successfully delivered over 4000 projects across 20 countries. Become a member of a dynamic, fulfilling team that helps a broad range of life science products get to market more quickly, more affordably, and with the highest quality and safety standards possible in today's biotechnology, pharmaceutical, medical device, and combination product industries. With a reputation of providing unparalleled professional services and our highly collaborative team of engineering, compliance, and project management experts, Kymanox provides an outstanding opportunity for learning and career advancement. Kymanox encourages team members, especially new graduates, and young professionals, to work on a variety of projects to gain increased learnings in Kymanox's service offerings and the life science industry as a whole.
Kymanox is looking for motivated individuals who want to solve problems in the life science industries while doing the work they love and helping get modern medicines that enhance and save patient lives to market. Kymanox provides professional services related to engineering, compliance, and project management. We service clients ranging from Fortune 100 companies to virtual start-up companies. The company was founded in 2004 and has been growing steadily since its inception. Our corporate HQ is based in Research Triangle Park, NC, and we have offices in Boston, Chicago, Philadelphia, and New Jersey.
To learn more about our company, please visit our website : Life Science Solutions Kymanox
