Job Description
Description:
The Medical Device Manufacturing Operator is responsible for performing manufacturing tasks for the production of commercial medical devices according to Standard Operating procedures, and cGMP regulations.
Essential Functions:
- Perform manufacturing operations in accordance with established work instructions.
- Manage multiple and varied responsibilities in a fast-paced manufacturing environment with minimal supervision
- Complete the set-up, operation, disassembly, and cleaning of process equipment according to standard operating procedures
- Operate laboratory instruments such as balances, pH meters, Microscope etc.
- Ensure that any issues that might impede the production schedule or quality standards are communicated through the proper channels.
- Execute and witness batch record instructions during cGMP operations.
- Document production activities according to GDPs in corresponding batch records and log sheets.
Qualifications
Education:
- High School or GED - Required
Experience:
- 1 year or more in pharmaceutical manufacturing
Skills:
- Experience in a manufacturing environment
- Experience in an ISO environment
- Detail oriented with good hand-eye coordination for working with small components
- Must possess mechanical aptitude in order to work with precision equipment
- Good written and verbal communication skills
- Good record keeping skills
- Ability to perform basic mathematical calculations
- Experience in measurement methods and practices
- Must be a team player
- Must be able to wear required protective safety gear/equipment, including respirator mask - Advanced
Specialized Knowledge:
- Knowledge of GMP documentation and regulations
- Basic computer skills including the ability to input data, prior experience with computerized control panels preferred
- Ability to communicate verbally and read, comprehend and prepare documents in English
- Able to lift and move equipment into place with and without assistance
