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Quality Assurance Specialist

1 month ago

Lebanon, Pennsylvania, United States Kymanox Full time

About the Role:

The Quality Assurance Engineer will be responsible for providing support to various clients in the manufacturing and automation sector. This includes process development, scale-up, qualification, and technology transfer. The ideal candidate will have a bachelor's degree in a science-related field and 2+ years of experience in the US medical device, pharmaceutical, or combination products industry.

Key Responsibilities:

  • Design, specification, selection, implementation, and startup of manufacturing/development facilities, utilities, equipment, and systems.
  • Troubleshooting, root cause problem solving, and continuous improvement of processes, equipment, and systems.
  • Request for proposal creation, project estimating, capital requests, vendor selection & management, and project budgeting.
  • Commissioning/Qualification/Validation of facilities, utilities, equipment, and systems.

Requirements:

  • Bachelor's degree in a science-related field.
  • 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.
  • Strong organizational skills and verbal/written communication skills.
  • Highly motivated self-starter with a sense of ownership and willingness to learn.
  • Thrive in a fast-paced, growing, and dynamic work environment.
  • Ability to form partnerships with internal stakeholders.
  • 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.