Line Auditor, 2nd Shift

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.

Prior Experience Qualification and Skill Requirements

• 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.

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.
• The job 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

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

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.
• 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.

Work Schedule

• This position usually works for 8 hours during a shift.
• Hours of work are flexible and will fluctuate based on the needs of the business and the customers.
• The work hours can vary depending on customer requirements and staffing.