Quality Specialist (3rd Shift)
On-site · Macungie, Pennsylvania, United States or Allentown, Pennsylvania, United States
Job Summary
The Quality Specialist provides quality oversight and GMP guidance within Sharp Commercial sites, supporting and implementing GMP initiatives and continuous improvement opportunities. Key responsibilities include managing non-conformance investigations, auditing internal processes, reviewing quality documentation, and supporting customer relationships. A working knowledge of FDA regulations related to Pharmaceutical Packaging Operations is essential. Candidates should have a Bachelor’s degree or Associate’s degree with relevant experience, strong analytical skills, and the ability to communicate effectively.
Required Qualifications
- Bachelor’s degree or Associate's Degree
- One to three years related experience (Bachelor's) or three to five years related experience (Associate's)
- Ability to apply moderately complex mathematical operations
- Above average writing and verbal skills
- Ability to independently make rational decisions pertaining to Quality and Compliance
- Intermediate Windows applications including Microsoft Office Suite and electronic QMS
Desired Qualifications
- Outside certification of quality skills and practices (i.e. ASQ, CQIA, CQI, CQT, Lean Six Sigma)
- Experience in inspection of Pharmaceutical or related industry
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