Description
Description:Responsible for monitoring production areas to ensure quality and compliance with all SOPs, cGMP, company policies, as well as FDA and other government and safety regulations.
Major Job Duties:
- Perform line clearance, inspections, and physical testing.
- Identify, investigate, and prepare reports on quality issues.
- Interpret generated data and communicate results to Quality management.
- Maintain effective communication and partnership with Operations department.
- Adapt to changes in the work environment and must be able to change shifts as needed.
Education:
- High school diploma or GED required.
- Two year certificate from college or technical school preferred.
- Three years related QA experience in a manufacturing environment.
- Strong understanding of cGMP concepts and requirements.
- Must be able to read, write, speak, and understand fluent English.
- Basic fundamental understanding of mathematics.
- Intermediate knowledge of MS Office.
- Able to demonstrate accuracy and thoroughness while completing work in a timely manner.
- Follows instructions, policies, and procedures.
- Able to speak effectively before small to moderate sized groups.
- While performing the duties of this job, the employee is regularly required to stand; work, climb stairs and use hands to finger, handle, or feel.
- The employee is occasionally required to reach with hands and arms.
- The employee must regularly lift and/or move up to 50 pounds.
- The employee is regularly exposed to moving mechanical parts or airborne particles.
- The noise level in the work environment is usually moderate to loud.
- These physical demands are representative of the physical requirements necessary for an employee to successfully perform the essential functions of this job.
- Reasonable accommodation can be made to enable people with disabilities to perform the described essential functions of this job.