Senior Quality Specialist (2nd Shift)

Sharp Services

Allentown, United States
On-site
Gmp guidance and support
Fda regulations knowledge
Data analysis and recommendations
Sharp Services is seeking a Senior Quality Specialist for their 2nd shift operations in Allentown, responsible for ensuring quality oversight and compliance within pharmaceutical operations. The role involves collaborating with internal teams and external stakeholders to implement GMP initiatives and support continuous improvement

Job Summary

  • Provides quality oversight, GMP guidance and support, and makes quality related decisions for designated functional areas within Sharp Commercial sites.
  • Serves as a Quality SME responsible to lead, support, design, and implement GMP initiatives and continuous improvement opportunities.
  • Must possess strong working knowledge of FDA regulations pertaining to Pharmaceutical /Pharmaceutical Packaging Operations.

Matching Summary

Match Score: 85

Sharp Services is seeking a Senior Quality Specialist for their 2nd shift operations in Allentown, responsible for ensuring quality oversight and compliance within pharmaceutical operations. The role involves collaborating with internal teams and external stakeholders to implement GMP initiatives and support continuous improvement.

Skills & Requirements

Must-have

  • GMP guidance and support
  • FDA regulations knowledge
  • Data analysis and recommendations
  • Non-conformance investigations
  • Customer relationship management
  • QMS actions completion
  • Process control and improvement

Nice-to-have

  • Strong working knowledge
  • Independent assessment of issues
  • Proactive risk identification
  • Training and coaching colleagues
  • Flexibility to meet organizational needs

Key Requirements

  • 3-5 years related experience with Bachelor's degree
  • 5-7 years related experience with Associate's Degree
  • Minimum 7 years related experience
  • Experience in Pharmaceutical or related industry inspection
  • Outside certification of quality skills and practices highly desired
  • Ability to make independent rational decisions

Work Rights

Not specified

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