Quality Specialist (3rd Shift)
On-site · Macungie, Pennsylvania, United States or Allentown, Pennsylvania, United States
Job Summary
The Quality Specialist provides quality oversight, GMP guidance, and support, making quality-related decisions for designated functional areas. They actively participate in non-conformance investigations, review and approve quality documentation, and support customer relationships related to Quality as needed. Responsibilities include implementing GMP initiatives, conducting internal audits, ensuring compliance, and supporting the training department’s efforts. A Bachelor's degree with related experience is preferred, along with proficiency in communication and problem-solving skills, and experience with FDA regulations.
Required Qualifications
- Bachelor’s degree is preferred with one to three years related experience or Associates Degree with three to five years of related experience
- Experience in inspection of Pharmaceutical or related industry
- Ability to effectively communicate (written and verbally)
- Ability to make independent rational decisions pertaining to Quality and Compliance
- Ability to apply moderately complex mathematical operations including an understanding of statistical skills
Desired Qualifications
- Outside certification of quality skills and practices (i.e. ASQ, CQIA, CQI, CQT, Lean Six Sigma etc.)
- Experience in inspection of Pharmaceutical or related industry
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