Location: Buena, NJ
The Quality Control Chemist I is responsible for providing accurate and timely testing of in process, HPLC, finished product, stability and raw material samples, to support the production schedule. This position will also ensure the safety and reliability of products produced in compliance with quality and regulatory requirements.
Reporting Relationships: No Direct Reports
- Perform QC testing of in-process, finished product, packaging components, stability and raw material samples using techniques such as HPLC, GC, viscosity, wet chemistry techniques, Keyence, caliper, specific gravity, conductivity, pH 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.
- Evaluate out-of-specification (OOS) results immediately and work directly with supervisor to determine root cause.
- Responsible for writing deviations for OOS results generated during testing.
- Maintain laboratory equipment and instrumentation in good working order. Follow 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.
- 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 0-2 years of experience in medical device and/or pharmaceutical QA or QC position.
- HPLC experience preferred.
- Injectable packaging visual and dimensional testing preferred.
- 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.
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.
- While performing the duties of this job, the employee is regularly required to talk or hear.
- The employee frequently is required to stand; walk; use hands to handle or feel; and reach with hands and arms.
- The employee is occasionally required to sit; climb or balance; and stoop, kneel, crouch or crawl.
- Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception and ability to adjust focus.
- The employee must be able to wear all required PPE, including safety glasses, ear plugs, and safety shoes.
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.