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 testing and release of the finished products manufactured at the site. This may include performing testing of human blood samples. This position is also anticipated to perform validation activities of equipment, as well as performing software validations as needed. All activities must comply with FDA’s Quality System Regulations and ISO 13485 quality standards.
- Perform software validation for spreadsheets.
- Execute validation protocols for moving equipment for production purposes including such activities of collation and analysis of data and authoring of validation reports.
- Perform Quality Control testing on finished products, work in process, and/or raw materials.
- Analyze trends in company quality systems and other areas as requested.
- Participate in regular employee training in GMP and ISO regulations.
- Support company goals and objectives, policies and procedures, Good Manufacturing Practices, and FDA regulations.
- Support and participate in quality remediation projects including revision or creation of procedures and work instructions.
Ideal Candidates should have:
- Ability to drive projects to timely completion.
- 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 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 and/or in a laboratory environment. Lab coat, safety glasses, and gloves are required when performing activities within the laboratory environment. 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.