Description Job Purpose · Performs Quality Attribute Inspections of the product through the packaging process in compliance with company policies/procedures, FDA and cGMP regulations. · Ensures the accuracy and completeness of batch records. Performs other duties as assigned or apparent Essential Duties and Responsibilities: · Review Batch Records and applicable documentation to ensure complete, thorough and accurate data. · Responsible for ensuring a high level of employee accountability and performance. · Maintains quality assurance documentation including shift pass downs. · Keep QA work station clean and orderly. · Perform packaging line clearances. · Pull Retain, Stability, and Lab samples. · Perform or verify Quality Finished Product Attribute Inspections. · Perform AQL Calculations. · Verify component Exhibits · Verify all documents are present within the batch record. · Support validation and manufacturing studies, including special sampling and testing. · Communicate with Management any quality issues identified with product · Supplemental Functions: · 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 the product delivered 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: Skills: • Detail oriented. • Technical writing skills required. • Good written, oral and comprehensive communication skills. • Operating computer and relevant software;. • Must be proficient in MS Word, Excel, and PowerPoint; Abilities: • The ability to create and contribute to an environment that values people, encourages trust, teamwork, and open communication; and provides participation, learning, feedback and recognition. • The ability to effectively manage one’s self, demonstrates integrity, be productive under pressure, and achieve development goals. • Ability to handle contending priorities and managing partner expectations • The ability and willingness to change direction and focus to meet shifting organizational and business demands. • Assist in other activities (as needed) for Quality Operations management. • Must have the ability to make recommendations to effectively resolve problems or issues by using judgment that is consistent with applicable standards, practices, policies, procedures, regulation or government law. • 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. Requirements Education/Experience: · Minimum of High School Diploma or GED required. Working Conditions / Physical Requirements: · This position requires bending, typing, lifting (up to 25 1bs.), standing, sitting and walking throughout the facility.