COORDINATOR QUALITY 3rd shift QA

SUMMARY: Issues labels and shop floor paperwork according to the current production schedule. Receives and verifies the accuracy of incoming labels from vendor and performs various quality functions to assure that production produces a good quality product.

Essential Functions

• Behavior: Exhibit team player qualities of cooperation and coordination; professional interaction in all business contacts, all day, every day
• Attendance: Present for work when scheduled is a mandatory function.
• Safety: Your compliance with all company safety rules, procedures, and guidelines are essential.
• Organize and maintain retain samples and batch records in accordance with cGMPs.
• Ensure that all samples are pulled and delivered to the QC Lab.
• Issue formulas to PM work orders by batch.
• Assure that all paperwork is accurate and complete prior to turning into the Doc Center.
• Report any documentation errors, out of tolerance reconciliation issues for investigation and corrective action to the supervisor.
• Calculate and enter information from the Direct Labor sheet.
• Responsible for issuing all shop floor paperwork from SAP and SOP intranet system to packaging floor. This includes printing and issuing case labels to packaging and outsourced suppliers.
• Responsible for receiving and issuing all pre-print and seals to the packaging floor and contract packaging. This includes receiving returned labels and cycle counting of inventory.
• Handles label vendor returns, destruction of defective or obsolete labeling. (Contract Packaging is MO only).
• Operate rewind equipment.
• Facilitate with QA Management final disposition of Quarantined and Non-Conforming Materials.
• Must be able to operate an electric pallet jack on a daily basis.
• Be flexible and able to work in all QA areas as assigned.

Marginal Functions:

• Maintain standards used to gage finished product quality.
• Contribute to documented procedures.

Physical Activities: Walking, talking, hearing, climbing, balancing, reaching, grasping, standing, and stooping.

Physical Demands: Routinely lifting label rolls 5-40 lb. frequently lift samples 1-5 lb.

Visual Acuity: Clarity of vision at 20 inches or less, with the critical ability to distinguish colors and adjust eye to bring objects into sharper focus.

Environmental/Atmospheric Conditions: Worker exposed to extreme heat and cold with temperatures sufficiently high or low to cause marked bodily discomfort. Exposed to sufficient noise to cause worker to shout in order to be heard above the ambient noise level. Worker exposed to hazards such as proximity to moving mechanical parts. Works in laboratory, production line and warehouse environments.

Education: High School Diploma or GED is required. Two years of college level course work is preferred or equivalent knowledge in math, science and computers achieved from work experience and/or on-the-job training.

Experience: A minimum of 2 years experience in a cGMP regulated industry is preferred. Ability to work in Microsoft programs (Word, Access, and Excel) and an ERP system is required.

Special Knowledge: Demonstrated computer skills. Demonstrated ability to handle multiple tasks.

Technical Skills: Works well with computers (ability to input or create spreadsheets, databases, etc.)

Non-Technical Skills: Requires excellent oral & written communication skills. Ability to communicate cGMP standards to multiple departments. Ability to train associates on cGMPs. Excellent organizational skills and attention to detail.