Description Position Summary: • Performs Weight Check and Quality Attributes Inspection of the product through the filling and 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. Primary Accountabilities: • Successfully complete required Quality Assurance Training as outlined per procedure. • Successfully complete DEA certification. • Review production batch records for accuracy and completeness. • Monitor and perform start up, in-process and finished product inspections including weight checks and attribute inspections during production. • Maintain quality assurance documentation. • Promote teamwork both within the QA area and other departments. • Keep line and work station clean and orderly. • Inspect and release machines and processing rooms for production. • Support validation and manufacturing studies including special sampling and testing. • Organize workload during lot and batch changeovers for efficient execution. • Review and approve production batch records for release into production. • Investigate out of range percentages. 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. Requirements Knowledge, Skills & Abilities: • High School Diploma or GED. • Minimum of 1 year of pharmaceutical Quality Assurance/Production experience or 2 years related experience preferred. Knowledge of cGMP preferred. • 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. • Position requires reaching (waist to head), bending (waist to floor), lifting (up to 25 lbs.), reaching (waist to head), vision (20/20), standing (40%), sitting (20%), walking (40%), typing, and hearing. • Incumbents are required to wear hearing protection and other non-specified protective equipment as necessary.