Description Job Purpose: • Perform visual inspection of injectable products in compliance with company policies/procedures, FDA and cGMP regulations • Maintains quality assurance documentation by ensuring the accuracy and completeness of batch records. • Promotes teamwork both within the QA Team and other departments. • Monitor all packaging areas and personnel for adherence to all cGMP, SOP's and safety regulations. • Keep line and work station clean and orderly. • Perform line clearance including equipment, components and label verification. • Communicate quality- related observations, issues, problems, discrepancies and any violations of company policies or procedures to the Supervisor. • Specific expertise, skills and knowledge within quality assurance gained through education and experience. • The ability and willingness to change direction and focus to meet shifting organizational and business demands. • Able to handle diversity of projects. • The ability to create and contribute environment that values people, encourages trust, teamwork, and open communication, and provides participation, learning, feedback and recognition. • The ability to effectively manage one self, demonstrates integrity, be productive under pressure, and achieve development goals. Essential Duties and Responsibilities: • Monitors and performs finished product attribute inspections. • Performs visual inspections of Outsourcing products if deemed necessary or required. • Supports secondary packaging operations by performing QA verifications of packaging, label verifications, etc. • Maintains quality documentation and review to ensure completion and compliance. • Promotes teamwork both within the QA Team and other departments. • Keep line and work station clean and orderly. • Ensure that there is no cross contamination. • Perform line clearances. • Support validation and manufacturing studies including special sampling and testing. • Organize workload during lot changeovers for efficient execution. • 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. Supplemental Functions: • Copying, filing, and scanning of documents. • Performs other similar duties as required. • Assist in other activities (as needed) for Quality Assurance management Knowledge & Skills: • Minimum of 1 year of pharmaceutical Quality Assurance/Production experience or 2 years related experience preferred. Knowledge of GMP preferred. • Good written, oral and comprehensive communication skills. • Strong understanding of document control procedures, standards, and best practices • Detail oriented. • Good computer skills in MS Outlook, MS Word, MS Excel, Internet, Email and basic typing skills. • Good visual acuity and observation skills. • Good written, oral and comprehensive communication skills. • Able to handle diversity of projects. • Specific expertise, skills and knowledge within quality assurance gained through education and experience. • A broad perspective that aligns decisions to organizational objectives and long-term consequences of day-to-day activities. • The ability and willingness to change direction and focus to meet shifting organizational and business demands. • The ability to create and contribute environment that values people, encourages trust, teamwork, and open communication, and provides participation, learning, feedback and recognition. • The ability to effectively manage one self, demonstrates integrity, be productive under pressure, and achieve development goals. • Incumbents are required to wear hearing protection and other non-specified protective equipment as necessary. Requirements Job Specifications and Qualifications: • Visual Inspection certification Education/Experience: • 1-3 years of related experience in the pharmaceutical industry. • High School Diploma or GED Working Conditions / Physical Requirements: • This position requires bending, typing, lifting (up to 40 1bs.), standing, sitting and walking throughout the facility.