Line Auditor II, 2nd Shift

Job Purpose: 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.

Job Duties and Responsibilities: (Percentages = priority and approximate time focus)

1. 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%

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

Licenses and Certifications: None

Certifications or required class attendance: 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 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 English.
• Can perform mathematic addition, subtraction, multiplication, and division using all units of measurement.
• Can compute rate, ratio and percent.

Core Purpose : To contribute to the success of our customers by helping them grow and save money.

Vision: Become the most respected, most admired, most sought after CPG contract manufacturer in the World.

Vivid Description: With our intimate knowledge of our customers we will provide products and services so valuable that we are considered an integral member of their team that they cannot live without. We will collaborate in a way that creates a tremendous competitive advantage to our customers. This competitive advantage comes from providing innovative products to the market faster than anyone, at the greatest value to the customer, and with quality that exceeds the consumer's expectations. Great customers seek us out. Our halls are filled with awards and testimonials bestowed upon us by our customers and suppliers. Our culture and environment attract the most passionate, committed, and highest achieving people in our industry. Our employees live our core values. We are proud of our accomplishments but are never satisfied with the status quo. We continuously improve in everyway, everyday.

Core Values

Customer Focused – Our success is based on customer intimacy-understanding the unique needs of each customer and providing products and services that always exceed their expectations. .

• We are passionate, intense and relentless in the pursuit of customer satisfaction.
• We have an intimate understanding of the uniqueness of each customer and what will make them successful.
• We provide products and services that each customer wants at the right price, the right quality with responsiveness and dependability.
• We make every customer experience a positive no matter the situation.
• We always put the customer first. Everything is looked at from the customer's perspective.
• We provide creative solutions that are win-win.
• We always strive to WOW the customer.

Continuous Improvement – We stay ahead of the competition by continually and relentlessly examining how we do business and determining new ways to move the business forward. This is everyone's primary responsibility to themselves, to their teammates and the company.

• We use data to focus our improvement efforts and measure results.
• We use lean tools to identify waste and drive it out of the process.
• We are proactive. We anticipate problems and take corrective actions before they affect us or our customers.
• We accept nothing less than a quality product. We must always meet or exceed specifications.
• We are creative and innovative in the way we approach problem solving.

Results Culture – Our people thrive on achievement. It is a core trait of our people and organization. We take on challenges that make us better and are not satisfied until we accomplish our objective.

• We select the best.
• We accept nothing less.
• We create an environment for people to succeed.
• We are committed and accountable to our values, our objectives and our company.
• We have an urgency and passion to accomplish our goals.
• We are always ethical.
• We treat others with respect.
• We have integrity. We strive to do what we say we are going to do .
• We never give up.
• We are focused on results.

Stewardship – In order to fulfill our core purpose and achieve our vision we must be fanatical stewards of our resources (money, time, tools, equipment, materials, etc) for the betterment of the company and our customers. Good Stewardship is the key to the long-term viability of the company.

• We never want to "walk by" an opportunity, but instead to be alert to opportunities and evaluate them based on how they are driven by our Core Purpose and fulfill our Vision. It is by seizing the right opportunities that we "capitalize" on chances to advance our vision. Opportunities are all around us everyday both within our facilities and in the marketplace. By taking full advantage of the right ones, we are good stewards.
• We spend Apex's and our customer's money like it is our own.
• We use our resources in a way that builds trust between the company and its customers.
• We use our resources in a way that builds trust between the company and its employees.
• We look at every dollar spent and resource used as an investment that needs a return.
• We only spend or use resources when we believe that there is a return for the company and its customers.
• We consider the short term impact of how we use resources and spend money but we are primarily interested in the long term affect