Responsible for endorsing process and product quality, efficacy, and safety through the routine assessment of plant operations and finished products. Responsible for ensuring adherence to the regulatory and procedural requirements that govern those operations and products.
Essential Duties and Responsibilities (these are primary responsibilities of the role and the incumbent will perform other duties as assigned):
- Performs routine tests and ensures test results are within specified limits.
- Inspects product as required per protocol and suggest improvements and efficiency changes.
- Responsible for alerting supervisor to out of spec conditions; reports problems and/or issues.
- Records data / SPC charts. Performs analysis, has basic understanding of SPC.
- Read and understand technical specifications, blueprints, update/maintain POM’s, JIB’s, SOP’s, Specs and perform calibrations.
- Ensures good documentation practices are followed at all times.
- Assist in training peers within the department.
- Promotes continuous improvement by participating on teams and projects.
- Must be able to effectively communicate across all departments and levels of management.
· Performs all other duties as assigned.
Job Requirements (Education, Experience and Qualifications):
- High School diploma or equivalent with 2-4 years’ experience
- Some computer knowledge in Microsoft Office applications and ability to use other appropriate software.
· Knowledge of GMP documentation and FDA.
· Must have the ability to use a variety of basic hand tools.
· Must have good interpersonal and communication skills, be a team player, and detail oriented.
· Must be self-motivated and able to work with minimum supervision.
· Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions.
Physical / Safety Requirements
· Duties may require overtime work, including nights and weekends
· Use of hands and fingers to manipulate office equipment is required
- Requires bending, walking, standing, sitting, lifting up to 20 lbs., stretching, climbing stairs, pulling and pushing.
· May be required to pass a color and/or vision test depending on work area.