QUALITY ASSURANCE SPECIALIST

RESPONSIBILITIES: 

Documentation: 

• Writes, and approves Non Conformances, deviations, OOS’s, &corrective action/preventative action (CAPA) management that impact plant operations and products and provide recommendations and corrective actions and effectiveness plans.
• Performs problem analysis and CAPA management. 
• Acts as a technical resource within the plant for problem solving, training on the Non Conformances/CAPA system, and continuous improvement.
• Compiles required Non Conformances and CAPA metrics.
• Assembles Non Conformanceand CAPA information for monthly and quarterly management review presentations.
• Monitors and analyzes plant Investigation and CAPA metrics and information. Ensures all deadlines are met for action items. 
• Completes customer complaint investigations as requested and per timelines provided.  
• Ensures that Non Conformances/CAPA documentation is compliant with site and Corporate policy/procedure requirements. Ensures investigations are approved by correct areas.
• Assists manufacturing and other departments in identifying root cause and implementing effective corrective actions for those circumstances where quality standards are not met. 
• Trains new personnel on the Investigations and CAPA system. 
• Coordinates with QA Manager to determine if batch will be a designated validation or stability batch.
• Maintains the effectiveness of the investigation system.
• Other related duties as assigned.

QUALIFICATIONS: 

• Bachelor’s Degree, preferably in Science, Engineering, Math/statistics, or equivalent combination of education and experience. 
• 2 years of non-conformance investigation experience. 
• 2 years of experience in GLPor GMP environment.
• 2 years experience reading, following, writing, reviewing, and approving SOP’s, protocols, technical reports for validations (methods, processes, & cleaning), protocols for equipment validations, summaries of data, annual summary reports for water systems, environmental monitoring, etc.
• Proficient in MS Office suite of programs (Excel, Office, Outlook, Power-point,etc).
• Able to add, subtract, multiply and divide in all units of measure, using whole numbers, common fractions, decimals and percentages; calculate figures and amounts such as proportions and percentages; apply concepts of basic algebra and geometry.
• Able to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists.
• Strong organization, attention to detail, and communication skills, both written and verbal.
• Able to work with others in a positive team environment.
• Able to follow instructions and provide guidance and instruction to others.