Quality Assurance Specialist

Description

GENERAL SUMMARY:

First Priority, Inc. is the animal health industry's premier manufacturer and supplier of generic pharmaceutical products located in Elgin, IL. We are seeking a dedicated and detail-oriented Quality Assurance Specialist to join our team. The QA Specialist will play a crucial role in ensuring our organization runs production efficiently and smoothly meeting our customers expectations. The candidate will be responsible for following cGMP guidelines for inspection of production lines and the inspection of packaging components and labels. Releasing finished product and raw materials.

PRIMARY RESPONSIBILITIES:

Inspects finished product, brite stock, labels, compounding and production In-Process paperwork, packaging and In-Process products for conformance to cGMP standards. 

• Issues and reconciles labels, printed packaging or other controlled secondary packaging/labeling and documentation as required. 
• Utilizes various tools such as scales/balances, digital micrometers/calipers, height gauges, cap torque tester, label masters and manual/electronic label inspection equipment to perform inspection and release components and materials. 
• Documents inspection findings on associated records to be filed or attached to production batch records, receiving paperwork, validation protocols or other required cGMP documentation.
• Works in accordance with all company policies and procedures
• Follows proper health and safety guidelines (i.e. PPE, safety regulations, etc.)
• Perform other duties and special assignments as assigned

The work schedule for this position will be Monday through Thursday 6:00 AM to 4:30 PM; or Monday through Friday 7:00 AM to 3:30 PM.

Requirements

QUALIFICATIONS:

Education and/or Experience:

• High school diploma or equivalent
• 0-3 years Quality Assurance experience preferred within a Manufacturing Environment

TRAINING:

On the job training:

• MSDS/Hazardous Awareness
• Quality system procedures, documentation requirements and awareness
• Trained to use in-house Label software
• cGMP
• Appropriate SOPs per department requirements

Reasoning Ability:

• Ability to communicate effectively
• Understanding of weights and measures
• Ability to work independently/teamwork and without direction

WORK ENVIRONMENT:

• Warehouse/Manufacturing setting, low to medium noise level
• Temperature controlled environment
• Occasionally exposed to elements such as odor, noise, dust, chemicals
• Requires long periods of standing (75% - 100%)
• Ability to lift boxes and containers up to 20 pounds on a consistent basis

TOOLS AND EQUIPMENT:

• Microsoft Office
• Computer, printer
• Calculator 
• Scale/balance
• Digi Matic caliper
• Height gauge
• Hardness tester
• Friability wheel
• Ruler/tape measurer
• Label roll counter, label master manual/electronic label software
• Cap torque tester
• Appropriate personnel protective equipment (when necessary)

Please note this job posting is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.

FLSA: Non-Exempt