To ensure the Quality and Compliance of raw materials, finished products, and stability samples by performing laboratory analytical testing relative to the support of our clients operations and manufacturing needs. Responsible for preparing solutions and reagents for testing as required. Uses analytical laboratory equipment such as HPLC, UPLC, GC, UV and IR. Works independently and within team under direction of supervisor to accomplish tasks.
KNOWLEDGE, EXPERIENCE AND EDUCATION
- Bachelor’s Degree in Chemistry or related discipline, with 2+ years’ experience in a pharmaceutical quality control laboratory preferred.
- Ability to run chromatographic instruments independently within the Empower program
- General understanding of applying cGMP requirements for all data generated by the QC laboratory.
- Excellent oral and written communication, interpersonal skills, and computer literacy, including Microsoft Excel and Word.
- Working Knowledge of fundamental laboratory techniques and analytical instruments
- Strong attention to detail and ability to follow written procedures.
- Previous Empower Software experience preferred but not required
Duties / Responsibilities
|% of Time|
|1. Performs qualitative and quantitative analytical testing and completes associated documentation||75%|
|2. Participates in laboratory investigations.||10%|
|3. Participates in Continuous Improvement initiatives.||10%|
|4. Prepares lab for internal/external audits||5%|