QO Visual Inspector Tier I (Shift 3 6:00pm - 6:30am)

Description

Job Purpose: 

• Perform Quality Attributes and Visual Inspection of drug product through the packaging process including Visual Inspection in compliance with company policies / procedures, FDA and cGMP regulations. 
• Ensures the accuracy and completeness of manual and electronic batch records. 
• Assists with additional work duties or responsibilities as evident or required. 

Essential Duties and Responsibilities: 

• Monitors and performs visual inspections and finished product inspections. 
• Perform visual inspections of Outsourcing products. 
• Monitor all packaging areas and personnel for adherence to all cGMP, SOP’s and safety regulations. 
• Keep line and work station clean and orderly to ensure no product line contamination. 
• Perform line clearance including equipment, components and label verification. 
• Support validation and manufacturing studies including special sampling and testing. 
• Organize workload during lot changeovers for efficient execution. 
• Release finished product for packaging after visual inspection. 
• Review all completed batch record documentation to ensure completion and compliance with Good      Documentation Practices. 
• Perform QA functions for Accraply, HP, and Autoclave processes. 
• Cross-train in other department(s) to expand job knowledge. 

Supplemental Functions: 

Shop Floor QA Accountabilities 

• Assists with monitoring all production areas and personnel for adherence to all cGMP, SOPs, and safety regulations.

• Assist with development of solutions for chronic problems within quality assurance

• Communicate quality- related observations, issues, problems, discrepancies and any violations of company policies or procedures to Quality Management.

• Adherence to cGMPs is required at all times. All personnel own the quality of what they deliver and are responsible for notifying responsible management in a timely manner of regulatory inspections, serious GMP deficiencies, process deviations, product defects and related actions.

• Stay abreast of current FDA requirements and ensure compliance by familiarity with important department Standard Operating Procedures (SOPs) and routine observance of procedures being performed.

• Assist in other activities (as needed) for Quality Assurance management.

Job Specifications and Qualifications: 

Knowledge & Skills: 

• Detail oriented. 
• Good computer skills in MS Outlook, MS Word, and MS Excel 
• Good visual acuity and observation skills. 
• Good written, oral and comprehensive communication skills. 
• Ability to handle diversity of projects. 
• Specific expertise, skills and knowledge within quality assurance gained through education and experience. 
• Ability and willingness to change direction and focus to meet shifting organizational and business demands. 
• Ability to create and contribute to an environment that values people, encourages trust, teamwork, and open communication, and provides participation, learning, feedback and recognition. 

Education/Experience:

• High School Diploma or GED 
• Minimum of 1 year of pharmaceutical Quality Assurance/Production experience or 2 years related experience preferred. Knowledge of GMP preferred. 

Working Conditions / Physical Requirements: 

• Position requires reaching (waist to head), bending (waist to floor), lifting (up to 25 lbs.), vision (20/20), standing (40%), sitting (40%), walking (20%), typing, and hearing.