Line Auditor, 2nd Shift

Job Purpose: To contribute to the success of our customers by ensuring first pass quality of Finished Goods and Manufacturing Equipment through thorough, accurate, and timely audits of production lines and processes and inspections for cleanliness.

Job Duties and Responsibilities:

Audits production lines for conformance to requirements in the Batch Record, product specifications, and cGMP requirements and inspects manufacturing equipment for cleanliness.

• Performs audits on time, with a sharp focus on details.
• Accurately records audit results in Batch Records.
• Initiates corrective adjustments to manufacturing processes; records adjustments; performs documented rechecks to verify successful adjustment.
• Escalates issues per established procedures to ensure correction and containment.
• Immediately reports non-conformances to the Quality Unit.
• Supports investigation of quality events, as required to resolve issues.
• Complies at all times with Standard Work, cGMP, SOPs, and Work Instructions.

Understand and maintain a culture of "lean action" within the department so that we live Lean better than any organization.

• Implement and maintain standards and processes that eliminate waste throughout the department.
• Apply and utilize "lean tools" to permanently implement improvements.
• Institutionalize 5-S in all aspects of the department. (Sort, Straighten, Shine, Standardize, and Sustain)

Perform other work as assigned.

Direction and oversight: None.

Qualification and Skill Requirements:

Prior Experience:

Prior audit experience preferred.

Knowledge Requirements:

This position requires a high school diploma or equivalent. To be effective, this position requires the ability to multi task, demonstrate a sense of urgency, and the ability to organize.

Licenses and Certifications: None

Work Requirement:

This position may require significant work hours beyond the normal workday based on the demands of the business cycle, customer volume of business, and specific sales efforts underway. It has a moderate to high demand for tight deadlines. This position entails work of a cyclical nature. This position will experience moderate interruption in workflow, starting and stopping for production and customer requirements. Travel is limited.

Physical Requirements:

This position requires:

• Frequent (4-6 hours per day) standing and walking.
• Infrequent/Moderate (2-4 hours per day) bending, pushing, pulling, climbing stairs, reaching, lifting and grasping.
• Infrequent/Moderate (2-4 hours per day) repetitive motion, hand/wrist movement.
• Infrequent/Moderate (2-4 hours per day) working at a computer terminal.
• Sensory requirements: Good eyesight, normal hearing, and fluent in the English language.

Working Conditions:

• Indoors, seasonally cold, hot and humid.
• Will be exposed to various fragrances which at times may be at elevated levels.
• Moving and lifting objects, sometimes 50 lbs. frequently.

Work Schedule:

This position usually works for 8 hours during a shift. However, hours of work are flexible and will fluctuate based on the needs of the business and the customers. The job may require a maximum of 5 hours of work beyond the normal 40 work-week schedule depending on work demands. The work hours can vary depending on customer requirements and staffing.

Technical Competencies:

• Must demonstrate excellent verbal and written communication skills.
• Is accurate, precise and pays attention to detail.
• Is well organized and thorough in work habits.
• Familiar with the utilization of a PC and e-mail systems.
• Is proficient at Microsoft Windows XP and Microsoft Office XP or higher.
• Able to work independently and prioritize tasks.
• Able to operate measurement devices (calipers, scales, ruler, etc.).
• Can read and write at a 12th grade level.
• Can read and follow specifications written in English.
• Can perform mathematic addition, subtraction, multiplication, and division using all units of measurement.
• Can compute rate, ratio and percent.