Location: Buena, NJ
Provide 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.
- 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.
BS in Chemistry or related discipline, 2-5 years of pharmaceutical industry or laboratory experience.
- Industry experience using HPLC.
- Knowledge of cGMPs and good documentation practices.
- Strong foundation in analytical chemistry and quantitative analysis.
- Demonstrated ability to apply good laboratory techniques while maintaining the efficiencies required in Quality Control.
- Observant. Receptive to learning and applying new skills and techniques.
- Collaborative working style. Demonstrates professionalism, cooperation and willingness to support team members and company priorities.
- Well-developed interpersonal skills. Ability to get along with diverse personalities.
- Good written and oral communication skills.
- Demonstrated ability to work on multiple projects and meet timelines.
- Physical Demands
- Ability to lift
- Inside and outside work
- Move between buildings
- Temperature variations
- Sit and stand for long periods
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