Job Title: GMP Technical Specialist
The GMP Technical Specialist is responsible for the day to day set up, operation and cleanup of pharmaceutical equipment. The role requires knowledge and compliance with U.S. FDA Regulation 21 CFR Part 210, 211, and Part 820, where applicable.
Essential Duties & Responsibilities
- Must understand and follow instructions detailed in Development Records, Batch Production Records and Packaging Records
- Ability to document experimental results accurately
- Must be able to work in a fast-paced, priority changing environment
- Must possess mechanical aptitude and equipment knowledge to be able to assist in troubleshooting equipment issues
- Knowledge of disassembly, assembly, cleaning and operation of pharmaceutical equipment within a cleanroom setting
- Manage raw material, equipment and product inventory and warehousing
- Familiarity with shipping and receiving operations
- Flexibility to work overtime, potentially on short notice
Education and/or Experience
High School Diploma or equivalent, an AA/AS degree is a plus. A minimum of 5 years’ experience in pharmaceutical development or manufacturing required. Hot melt extrusion experience preferred. Knowledge of pharmaceutical cGMP is required.
A technical and analytical ability important to the success of this position. Familiarity with computers and Microsoft software (word, excel, outlook). Ability to pass a respirator fit test and physical. Knowledge of GMP operations, polymer processing, polymer materials or pharmaceutical sciences; U.S. FDA Regulation 21CFR Part 210, 211, and 820.
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
While performing the duties of this job, the employee is regularly required to walk, talk, and hear. The employee is frequently required to stand for extended periods of time and to use hands to finger, handle and feel. The employee is occasionally required to sit; reach with hands and arms; climb and balance; and stoop, kneel, crouch, or crawl.