Conducts analysis and experimentation on finished products, raw materials and experimental materials for product release and process development. Duties may include method development and validation and verification of compendia methods.
location: Philadelphia, Pennsylvania
job type: Contract
work hours: 8 to 4
- Performs receiving, logging, preparing retains, and properly distributing incoming samples for release testing according to the SOPs.
- Conducts release testing on raw materials to determine chemical and physical properties, utilizing wet chemistry testing and other techniques following USP, EP, and FCC compendia.
- Knowledge of HPLC,/ UPLC with UV/VIS, PDA and RI detector and experience using Waters Empower software.
- Knowledge of ICP-OES / ICP-MS and experience using Teva software.
- Knowledge of USP dissolution, Karl Fisher, FT-IR, UV/VIS, TOC
- Conducts release testing on finished product for customer shipments.
- Prepares standards and reagents necessary to completed all compendia testing.
- Performs instrument maintenance according to the SOP.
- Prepares reports, reviews results, and compares to relevant specifications and determines quality status of batches.
- Familiarity with out of specification processes (OOS) per cGMP.
- Initiates out of specification (OOS) investigations when applicable.
- Ability to perform and document all activities according to cGMP requirements.
- Ability to learn new analytical tests, instrumentation and procedures.
- Ability to work in fast paced production environment.
- Ability to report accurate and precise results in a timely manner.
- Ability to adhere to company policies.
- Ability to perform titration and pH testing.
- BS in Chemistry or equivalent scientific discipline.
- A minimum of 2 years in an industrial related instrumentation laboratory.
- Must have good scientific, conceptual and analytical techniques.
- Familiar with Microsoft Word and Excel
- Previous experience operating FTIR, UV/VIS, TOC, and pH meter preferred.
- Must be flexible with work hours, afternoon shift, some overtime, and weekends as required.
- Prior pharmaceutical experience preferred.
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.