Quality Assurance Analyst

Job Title:  Quality Assurance Analyst 
Location:  South Plainfield, NJ
Hours / Schedule:  M-F, 8 AM- 4 PM
Type:  Direct Hire

Responsibilities
Ensure the generation and completion of investigation reports (i.e Nonconformance and Root Cause investigations for Corrective and Preventative Actions (CAPA).  This includes, but is not limited to, providing quality, compliance, and technical feedback/review/approval regarding quality and manufacturing investigations. Will also support the trending associated with quality and manufacturing investigations, Key Performance Indicators (KPIs) and / or other Quality Metrics, support and compile reporting regarding COQ (Cost of Quality), APR Annual Product Review, support internal Validation (IQ/OQ/PQ) protocol completion, support regulatory and customer audits and interact with the customer to resolve concerns regarding quality and manufacturing investigations. 
Responsible for oversight and execution of critical and non-critical deviations and investigations related to quality and Manufacturing.

• Facilitates generation of clear, concise and thorough investigations by providing sound quality and technical feedback.
• Support quality and manufacturing investigations resulting from Out of Specification Results (OOSs) 
• Investigate in-process and finished good non-conformances to identify root causes of production NCs.
• Investigate and write investigation summary reports for deviations across all functions, including Quality, Manufacturing, Validation, Engineering, Supply Chain, and Maintenance.
• Conduct root cause analysis and utilize critical thinking when identifying and analyzing information accuracy and reliability.
• Compile data and complete Corrective Action Preventive Action (CAPA) reports to identify root causes of issues.
• Compile data and complete investigations resulting from customer complaints.
• Ensure that investigation documentation moves through the approval process on a timely basis.
• Works alongside manufacturing, quality assurance/quality control, and other applicable departments.
• Tracks, monitors, and closes quality and manufacturing investigations.
• Identifies opportunities for continuous improvement.
• Review and compile data for KPI reporting directly for COQ (Cost of Quality).
• Compile and create (APR) Annual Product Review reporting.
• Interface with all levels of the organization on behalf of QA Investigations as needed.
• Support the generation of Quality Metrics and KPI as applicable.
• Ensure spreadsheets/databases are current and available for investigation meetings and daily reporting.
• Participate in audits, customer, internal, external, as well as regulatory inspections as needed.
• Assist with compiling and completion of documentation regarding Validation (IQ/OQ/PQ) reports.
• Handle special projects or assignments as directed by Director, Quality and Compliance as needed.

Requirements        

• Bachelor's Degree (B. A.) from four-year college or university; 1 to 2 years related experience and/or training; or equivalent combination of education and experience.
• Working knowledge of  ISO-22716, cGMP's.
• Thorough knowledge of the complaint process, including investigation and root cause analysis.
• Proficiency in Microsoft Office Suite, SharePoint, etc.
• 1 -2 years in Cosmetic OTC, Pharma or Medical Device industry, with emphasis in quality
• Should have knowledge of Inventory software; Manufacturing software; Order processing systems; Excel Spreadsheet software and Microsoft Word Processing software.

Benefits
System One offers eligible employees health and welfare benefits coverage options, including medical, dental, vision, spending accounts, life insurance, voluntary plans, and participation in a 401(k) plan. 

#M3

Ref: #558-Scientific