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.