Role OverviewThe GMP Operations Specialist is an experienced pharmaceutical manufacturing professional who helps clients improve operational performance, readiness, and execution within GMP-regulated environments.
What You Will Do
Evaluates manufacturing operations, organizational readiness, and business processes to identify performance gaps, operational risks, and opportunities for improvement. Develops and implements practical solutions to enhance productivity, compliance, quality, throughput, and overall operational effectiveness.
Why It Might Be a Fit
The role requires strong analytical, communication, and change management skills to achieve sustainable operational excellence.
Requirements
- Bachelor's degree in a scientific discipline or equivalent combination of education and experience
- Minimum of 6 years of experience in pharmaceutical manufacturing, with a focus on aseptic operations
- Proven expertise in aseptic techniques, cleanroom operations, and gowning procedures
- Comprehensive understanding of cGMP regulations and regulatory requirements for aseptic manufacturing
- Strong analytical and problem-solving skills, with the ability to assess complex situations and develop practical solutions
- Excellent communication, presentation, and interpersonal skills, with the ability to effectively engage and influence clients at all levels
- Ability to manage multiple projects simultaneously, prioritize tasks, and meet deadlines
- Willingness to travel to client sites as needed
- Certification in Aseptic Processing or relevant professional credentials are desirable
Benefits
- Average base salary range - not including benefits, and potential overtime and/or Cost of Living Adjustment
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