We are seeking a Quality Specialist I to support GMP compliance and batch disposition activities within our pharmaceutical operations. This hybrid role (3 days onsite in West Point, PA) will ensure that clinical supply materials are produced in accordance with company procedures, policies, and all applicable regulations. The ideal candidate will have strong problem-solving skills, the ability to manage multiple priorities, and a proven track record of working independently while collaborating effectively in a team setting.
Key Responsibilities
- Evaluate and disposition clinical supply materials, ensuring compliance with internal procedures, policies, and governing regulations
- Support the preparation, review, and improvement of procedures and processes
- Contribute to continuous improvement projects aimed at improving yield, reducing cost, or decreasing processing cycle times
- Assist with the coordination and investigation of significant quality events, including fact-finding activities
- Apply and promote the use of Lean Six Sigma and Company Production System (MPS) tools in problem-solving and daily operations
- Coordinate with cross-functional teams to ensure operational and compliance objectives are met
Skills & Qualifications
Required
- Bachelor’s degree or higher in Engineering, Science, or related discipline
- Minimum 2 years of experience in a GMP-regulated environment within the pharmaceutical or equivalent industry (Technical, Engineering, Quality, or Operations)
- Familiarity with batch disposition activities
- Strong problem-solving and communication (written & oral) skills
- Ability to manage multiple priorities effectively
- Proficiency with Microsoft Office applications (Excel, Outlook, MS Access, Teams)
- Strong attention to detail, flexibility, and awareness of production and quality control challenges
Preferred
- Proven ability to work independently and in a team environment
- Strong organizational, interpersonal, and time management skills
- Experience with ERP/MES systems; SAP knowledge preferred
Education
- Bachelor’s Degree (Engineering, Science, or related field) required
Additional Information
- Location: West Point, PA (Hybrid – 3 days onsite)
- Work Environment: GMP-regulated pharmaceutical setting with cross-functional collaboration
