There are multiple locations for this role:
Spring House, PA
West Chester, PA
Position Summary: Provides testing, technical and troubleshooting support in the QC laboratories. These functions include:
Collection, processing, method development and testing of chemical components, bulk products, raw materials, packaging components, finished products, marketed product stability, in-process materials, scale up, validation and cleaning validations to conform with specifications and standard operating procedures (SOPs).
Thorough knowledge of SOPs, USP and other applicable pharmacopeia.
Possess foresight to recognize task needs and performs the trained task without the request of management.
Reviews and/or writes the following documents: APR, SOPs, QSRs, Instrument qualification, protocol/report writing, trending and review/analysis of data.
Performs statistical analysis in support of APRs, Stability, and Product Release.
Complies with cGMPs, safety training and regulations.
Performs more advance technical projects under the supervision of management.
Maintains an environment of respect and teamwork with all co-workers.
Requirements: Education: Bachelor’s Degree in Microbiology, Chemistry, Biology, Natural Science, Medical Technology, or related science is required
Experience: Minimum 2 years of GMP/GLP quality control lab experience in a pharmaceutical and/or OTC and/or regulated environment is required.
Physical Demands: Capable of performing routine laboratory activities. Light to moderate lifting
Knowledge, Skills and Abilities: Basic knowledge/exposure of a LIMS system is preferred