Quality Specialist

We are seeking a highly motivated professional for a hybrid Technical Operations position based in West Point, PA. This role focuses on the evaluation and disposition of clinical supply materials to ensure total conformance with company policies and governing regulatory standards. Working in a collaborative team environment, you will play an active part in supporting continuous process improvements, coordinating quality event investigations, and standardizing operational procedures.

Responsibilities

• Evaluate and disposition clinical supply materials with the assurance that materials were produced in conformance to all applicable company policies, procedures, and governing regulations.
• Coordinate and support the preparation of procedures, manufacturing processes, and quality improvements.
• Complete projects to improve process performance, including continuous process improvements and value capture initiatives designed to improve yield, reduce cost, or lower processing cycle times.
• Assist in the coordination of significant quality events, including fact-finding and direct investigation support.
• Maintain a strong attention to detail, flexibility, and a proactive awareness of ongoing production and quality control problems.
• Manage multiple priorities effectively while demonstrating strong organizational, interactive, and time management skills.

Education

• Bachelor's Degree or higher in engineering, science, or a related discipline.

Experience
Required:

• Minimum 2 years of experience in the pharmaceutical or equivalent industry, within a Good Manufacturing Practice (GMP) related field including Technical, Engineering, Quality, or Operations.
• Familiarity with batch disposition activities.
• Strong problem-solving abilities combined with robust written and oral communication skills.
• Proven teamwork skills alongside the demonstrated ability to work independently.
• Proficiency in the use and maintenance of Microsoft applications (Excel, Outlook, MS Access, and/or Teams).

Preferred:

• Competency and background working with digital computer systems, including knowledge of ERP/MES and SAP systems.

Additional Information

• Work Location: This is a Hybrid Role based out of West Point, PA.
• Onsite Requirements: Candidate must be available to work 3 days onsite per week.