Line Auditor II, 2nd Shift

To contribute to the success of our customers by ensuring first pass quality of Finished Goods through thorough, accurate, and timely audits of production lines, production processes and inspections of packaging materials and finished goods.

(Percentages = priority and approximate time focus)

• Ensures material inspections (packaging materials and finished goods) required by SOP or customer(s) are aligned to customer and regulatory requirements. 45%
• Ensures finished goods and packaging materials are in accordance with customer and Regulatory requirements per acceptable quality level (AQL).
• Ensure compliance with all applicable SOPs, Work Instructions, Test Methods, and Standard Work.
• Ensures compliance with good documentation practices (GDP).
• Accurately records all inspection data and pertinent information in inspection database and inventory system.
• Initiates non-conformance process to ensure containment and control of product not meeting requirements.

Audits production lines for conformance to requirements in the Batch Record, product specifications, and cGMP requirements. 45%

• 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.
• Initiates non-conformance reports and supports investigations 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. 5%

• 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. 5%

None.

Prior Audit Experience Preferred.

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. 2- 3 years quality experience in a manufacturing environment preferred.

None

None

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.

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.

• 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.

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.

• 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 Office.
• 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…