A Quality Control Chemist II is responsible for providing accurate and timely testing of in process, finished product, stability and raw material samples, to support the production schedule. This person will also ensure the safety and reliability of products produced in compliance with quality and regulatory requirements.
Reporting Relationships: None
- Perform QC testing of in process, finished product, stability and raw material samples using techniques such as HPLC, GC, viscosity, wet chemistry techniques, specific gravity and TOC as directed by supervisor
- Maintain up to date documentation. Enter all raw data directly into the notebook and promptly calculate all test results.
- Peer review notebooks and test results generated by other QC team members.
- Critically evaluate and interpret experimental data. Immediately inform supervisor of issues and assist in the resolution of complex problems.
- Maintain laboratory equipment and instrumentation in good working order, following appropriate procedures for usage, clean-up and maintenance.
- Maintain and follow all laboratory systems, GMPS, safety and housekeeping requirements.
- Prepare and review SOPs, as required.
- Perform Quality Inspection functions, assist with water sampling and monitoring.
- Support sampling and testing for cleaning validation, process validation and method validation as required.
- Keep supervisor informed of all key quality findings and issues.
- Assume other activities and responsibilities from time to time as directed.
- Education: Bachelor's degree in Chemistry, Engineering or other Physical Sciences
- Minimum 2-5 years of experience in medical device and/or pharmaceutical QA or QC role
- Working knowledge in the quality systems for the medical device and/or pharmaceutical industry
- Working knowledge in FDA 21 CFR Parts 11, 210, 211 and 820 and ICH quality system requirements
- Ability to work collaboratively in a professional and effective manner across all Teligent departments
- Experience in using computer programs (MS Word, Excel, and Access)
- Strong verbal and written communication skills
- While performing the duties of this job, the employee is regularly required to stand. The employee is frequently required to walk; sit; use hands; talk; and hear. The employee is occasionally required to reach with hands and arms; climb or balance; stoop; kneel; crouch. The employee must occasionally lift and or move up to 25 pounds. Specific vision abilities required by this job include close vision, distance vision, and color vision.
- The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
This job description is not all-inclusive. It acts as a guideline and is subject to change over time. Additional duties may be assigned based on business needs.