Polymer Technology Systems, Inc
PTS Diagnostics is an innovative point-of-care diagnostics solutions provider that partners with patients and healthcare professionals to provide the right information at the right time to make the right decisions. The company’s name represents the three pillars upon which it has built its long-term success: People, Technology and Service.
This position provides support for Quality System activities associated with the validation of manufacturing, testing, and maintenance of products, equipment and processes at the site. This position performs validation activities of equipment and processes within a manufacturing setting. All activities must comply with FDA’s Quality System Regulations and ISO 13485 quality standards.
- Execute validation protocols for moving equipment for production purposes including such activities of collation and analysis of data and authoring of validation reports.
- Support and participate in quality remediation projects including revision or creation of procedures and work instructions.
- Participate in regular employee training in GMP and ISO regulations.
- Perform various statistical analysis techniques for validations.
- Work with Quality team to improve data collection strategies, key performance indicators for PTS processes
- Support company goals and objectives, policies and procedures, Good Manufacturing Practices, and FDA regulations.
Ideal Candidates should have:
- Ability to drive projects to timely completion.
- Ability to work with limited supervision and stay on task.
- Strong attention to detail required.
- Strong written and verbal communication skills are needed.
- Working knowledge of Excel to perform basic data analysis and tracking.
- Ability to utilize databases to perform work tasks.
- Able to work in a fast-paced, team environment.
- Proficiency in MS Office, Word, Excel, Outlook, etc.
Qualifications for the Role:
- Sophomore College level standing, working toward completion of a bachelor’s degree in a scientific discipline.
- Previous hands-on laboratory experience is a plus.
- Analytical and statistical data interpretation is preferred.
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
This position works in a typical office setting. Ability to sit for prolonged periods of time, typing, talking, listening, requiring clear near and midrange vision in connection with performing essential functions.
PTS, Inc. is an Equal Opportunity Employer.