Sharp Services is seeking a Quality Specialist for their 3rd shift in Macungie, Pennsylvania. The role involves providing quality oversight, supporting GMP initiatives, and ensuring compliance with FDA regulations in pharmaceutical operations
Job Summary
The Quality Specialist provides quality oversight, GMP guidance and support, and makes quality related decisions for designated functional areas within Sharp Commercial sites.
They are responsible to support, design, and implement GMP initiatives and continuous improvement opportunities within the Quality Operations organization through data analysis, training, motivation, and coaching.
The position requires a working knowledge of FDA regulations pertaining to Pharmaceutical / Pharmaceutical Packaging Operations.
Matching Summary
Match Score: 85
Sharp Services is seeking a Quality Specialist for their 3rd shift in Macungie, Pennsylvania. The role involves providing quality oversight, supporting GMP initiatives, and ensuring compliance with FDA regulations in pharmaceutical operations.
Skills & Requirements
Must-have
GMP guidance and support
data analysis
non-conformance investigations
quality documentation review
QMS actions
process control implementation
internal process audits
logbook review
customer audit support
DEA compliance support
in-process inspections
AQL sampling
Nice-to-have
customer interaction
continuous improvement
risk identification and resolution
training program implementation
Key Requirements
Bachelor’s degree preferred with 1-3 years related experience or Associate's Degree with 3-5 years related experience
Experience in inspection of Pharmaceutical or related industry required
Outside certification of quality skills and practices highly desired
Ability to apply moderately complex mathematical operations including statistical skills
Intermediate Windows applications including Microsoft Office Suite and electronic QMS