Quality Assurance Specialist II

• →Applicable to all levels of position 
• →Support the Quality System infrastructure by performing QA tasks pertaining to the documentation of processes.  
• →Perform Good Manufacturing Practices (GMP) compliance tasks, including audits, and documentation maintenance.   
• →Perform internal supplemental audits to verify that facility records files are in conformance to applicable Standard Operating Procedures (SOP) and GMP regulatory requirements. 
• →Perform training and manage the Quality System’s Training Program. 
• →Ensure documentation systems used in QA are properly maintained (e.g., QA audit records, training records). 
• →Perform protocol, data, and report inspections to verify conformance to applicable SOPs and GMP regulatory requirements. 
• →Evaluate responses to Incident reports and perform follow-up with respondents, or others, if needed, to ensure resolution. 
• →Make changes to SOPs, policies, training materials, and other documents in the records management system. 
• →Assist during regulatory inspections. 
• →Interface with various Divisions in problem resolution, and continual improvement. 
• →Support manufacturing failure investigations, and define investigational strategy. 
• →Facilitate meetings. 
• →Apply discretion in decision-making.   
• →Demonstrate independent judgment and make recommendations regarding business practices. 
• →Formulate, implement, interpret, and affect policies and operating practices. 
• →Communicate effectively with others. 
• →Perform work onsite.
• →Perform other duties as assigned.  

• →Bachelor’s degree, preferably in Chemistry or in physical or biological science.  
• →Minimum 3 years experience in a Food and Drug Administration (FDA) regulated manufacturing environment. 
• →Minimum 1-year experience training in a business setting.  
• →Minimum 3 years of progressive experience in Quality Assurance. 
• →Demonstratable strong written and verbal communication skills. 
• →Excellent organizational skills.            
• →Proven record of excellent documentation skills.  
• →Strong problem-solving skills. 
• →Work well under pressure and able to prioritize workloads. 
• →Ability to perform risk assessment.  
• →Experience fostering teamwork to get results. 
• →Well organized and multi-task oriented. 
• →Ability to work independently on multiple projects. 
• →Ability to read, write, and speak English competently.  
• →Ability to maintain, reliable and predictable attendance. 
• →Worked in pharmaceutical or cosmetic mfg. environment (preferred). 
• →American Society for Quality certifications (preferred). 
• →FDA & OSHA trained and familiar with current regulations (preferred). 
• →Project management and technical software skills (Excel, Access, etc.) required. 
• →Project management experience (preferred). 
• →Experience training safety, quality, and GMPs (preferred). 

The Quality Assurance Specialist is responsible for performing Quality Assurance (QA) functions to build, uphold, and improve the Company’s Quality Systems.  

• Perform at an experienced and functional level therefore requiring limited supervision. 
• Engage in Professional Development Activities.