Quality Assurance (QA) Specialist

The Quality Assurance Specialist supports in oversight and performance of functional areas, and training in regards to processes, documentation as they pertain to quality standards and governmental regulations. This individual is primarily responsible for the day to day operations within the Quality Assurance department, ensuring the company and its departments are following established protocols, completing required documentation and reviewing and/or verifying finished product specifications are being met.  

• Follows, assists, and collaborates with the Quality Assurance Supervisor in all matters  
• Ensures company is following established Standard Operating Procedures (SOP) and track data relevant to the company’s Quality Management System (QMS), including but not limited to product lot information, 3rd party test results and errors found in various areas of operations  
• Follows all regulatory, cGMP and USP guidelines as required by job function  
• Works in accordance with QA Supervisor to provide quality assurance oversight where the business is responsible for adhering to current Good Manufacturing Practices (cGMP) including warehouse, manufacturing processes, inspection, labeling and packaging, batch record review, batch disposition and product distribution as applicable  
• Ensures all work is performed and documented in a timely manner and according to approved SOP and in general compliance with cGMP  
• Demonstrates a high level of discretion in the timely identification and resolution of events potentially impacting the quality of products and processes  
• Provides an established technical expertise for current processes and oversee training of department personnel on new processes  
• Maintenance of retained sample storage  
• Performs and review routine manufacturing, environmental monitoring and quality control data for in-process and finished products  
• Collects required information for any batch production records  
• Samples, inspects and controls product label inventory  
• Follows and encourages safety and appropriate regulatory guidelines  
• Completes other projects and duties as required and/or assigned  

• Minimum 2 years’ experience in Quality Assurance, Sterile Compounding and/or GMP production facility preferred  
• Minimum 2 years’ experience with FDA-regulated operations (cGMP processes) preferred  
• Strong Microsoft Word and Excel skills  

• Minimum 3 years of experience in Quality Assurance/Control Operations, or a related field in the healthcare industry 
• BS in science or a related field is desired 
• Basic PC skills including MS Word and Excel 
• Demonstrated understanding of quality assurance in a regulated environment 
• Effective problem solving, strong communication (written and verbal) and organizational skills 

• Health/Dental/Vision 
• Flexible Spending Account (FSA) or Health Savings Accounts (HSA)  
• 401(k) with company matching  
• Paid Vacation (10 days) 
• Paid Holidays (8 days) 
• Potential for career growth within an expanding team and organization