QA Specialist

Description

Job Summary 

Manage all Quality Assurance activities utilizing the standard operating procedure at Aphena Pharma Solutions – TN. Support manufacturing Quality group’s mission with specific emphasis on document control & product approval activity 

Essential Functions 

• Ensuring cGMP compliance in all areas of operation with specific emphasis on 21 CFR 210 & 211 (and associated regulatory requirements). 

• Process and approve all new incoming product submissions and requests for production including submission to the required agencies (FDA CDER, DEA, CFSAN, etc.). 

• Ensure submission and maintaining of all First DataBank, Medispan, and other nationally recognized price sources (as required) product listings. 

• Review all change orders or formal deviation requests. 

• Assure compliance of all SOPs and perform annual internal audits with reports to the Senior 

• Director of Quality Assurance and Regulatory Affairs. 

• Coordinate SOP activity including review due dates, evaluation, development, response time and deployment. 

• Make change notice correction's which affect document control and revision. 

• Review and approve all master SOPs. 

• Observe and comply with all company established safety practices. 

• Participate in and complete all company required training and retraining. 

• Support manufacturing QC as needed. 

• Report on and present data to the Quality organization. 

• Observe and apply organizational policies, laws, rules, and regulation, typing accurately, making arithmetic calculations and analysis. 

• Comply with safety regulations and maintain clean and orderly work areas. 

• Participate in and complete all company-required training. 

• Create and submit all DEA reporting requirements, including but not limited to ARCOS, YERS 

• and inventory reports. 

• Responsible for serving on the QMR Team as well as on the External cGMP Audit Team. 

• All other duties as assigned 

Qualifications

Qualifications 

• Minimum high school and four-year S.S. degree or equivalent experience. 

• Requires extensive knowledge of cGMP standards and procedures. 

• Experience in developing and managing quality systems. 

• Must have strong decision-making and leadership skills. 

• Statistical QA analysis. 

• Proficient in Microsoft Office Suite (Excel, Word, Outlook) 

• Ability to communicate in written form and oral presentation. 

• Supervisory background or experience. 

• Manufacturing process experience (Production and Quality Control). 

Physical / Mental Demands 

• Frequent sitting, typing, and use of hands for data entry and document handling. 

• Frequent viewing of computer screens and printed materials. 

• Occasional walking, standing, and reaching for files or office supplies. 

• Occasional lifting and moving of objects up to 20 pounds. 

• Frequent mental focus and attention to detail required. 

• Frequent handling of confidential information with discretion and professionalism. 

• Frequent communication via phone, email, and in-person interactions. 

• Ability to manage multiple tasks, prioritize deadlines, and adapt to shifting demands. 

Salary : $48,000