Quality Assurance Specialist

3 days ago


Lebanon, Pennsylvania, United States Kymanox Full time
Quality Assurance Engineer

Kymanox is seeking a highly motivated and detail-oriented Quality Assurance Engineer to join our Manufacturing and Automation team. As a key member of our team, you will provide support to various clients covering a wide range of technical and compliance challenges.

Responsibilities:
  • Develop and implement process development, scale-up, qualification, and technology transfer strategies.
  • Design, specify, select, implement, and start up manufacturing/development facilities, utilities, equipment, and systems.
  • Troubleshoot and resolve root cause problems, and continuously improve processes, equipment, and systems.
  • Create request for proposal documents, project estimates, capital requests, vendor selection and management, and project budgeting.
  • Apply project management concepts and tools to drive program and project initiatives from concept to full implementation.
  • Engage with clients to build and maintain strong relationships and provide technical expertise.
  • Commission, qualify, and validate facilities, utilities, equipment, and systems.
Requirements:
  • Bachelor's degree in a science-related field such as Biomedical Engineering, Mechanical Engineering, or Chemical Engineering.
  • 2+ years of experience in the US medical device, pharmaceutical, or combination products industry.
  • Experience with generating SOPs for site readiness or technical operations is preferred.
  • Knowledge of Technical Writing and CGMPs and drug/device development.
  • Experience with MS Office products (Outlook, Excel, PowerPoint, Word) strongly preferred.
Desired Skills:
  • Detail-oriented and strong organizational skills.
  • Excellent verbal and written communication skills.
  • Highly motivated self-starter with a sense of ownership and willingness to learn.
  • Ability to thrive in a fast-paced, growing, and dynamic work environment.
  • Seasoned soft skills (i.e., high EQ).
  • Technology savvy.
Travel and Career Development:

Up to 10% travel is possible for support at tradeshows, conferences, and related events. A passport is required for this job.

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 and Benefits:

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.

Medical healthcare including dental and vision, short- and long-term disability, life insurance, matching 401(k) retirement plan, continuing education assistance, and other benefits.

Kymanox is an equal-opportunity employer and works diligently to protect the rights of job seekers by following all local, state, and federal laws as well as best Human Resource (HR) practices in the Life Science industry.



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