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 by performing the following duties.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.
Qualifications:
- Three years related QA experience in a manufacturing environment.
- Good Manufacturing Practices (GMP) - 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.
Non-Essential Skills:
- Able to speak effectively before small to moderate sized groups.
Education Requirements:
- High school diploma or GED required.
- Two year certificate from college or technical school preferred.
- 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.