EDUCATION / EXPERIENCE

• Bachelor’s degree in relevant scientific quality assurance / technical field
• 5+ years of experience
• Strong understanding of pharmaceutical cGMP, industry standards, and regulations
• Strong verbal and written communication skills with the ability to interact across functions, departments, and seniority levels
• Expert level user for Quality computer systems
• Knowledge of and ability to use Microsoft Outlook, Excel, and Word, as well as other web-based systems
• Thorough understanding of computer system validation and GAMP requirements

Key Competencies (knowledge, skills, and abilities every person must possess to be successful)

• Critical Thinking — using logic and reasoning to identify the strengths and weaknesses of alternative solutions, conclusions, or approaches to problems
• Excellent customer service skills and professional demeanor at all times to interface effectively with all internal and external customers
• Excellent verbal and written communication skills
• Energetic, enthusiastic, and motivated disposition
• Attention to detail with strong organizational skills
• Ability to explain problems, solutions and make recommendations, and the ability to manage various urgent requests in a professional manner
• Ability to analyze data/trends to make sound regulatory interpretation while preparing metrics and reports
• The ability to drive projects in relation to implementation of new workflows and updates to new system

• Responsible for the review, approval, and disposition of finished product for the site and final CoA signature
• Facilitates client project management as required ensuring “quality on time and in full”
• Coordinates the investigation and closure of non-conformances ensuring appropriate corrective and preventive actions (CAPA) and change controls are initiated and deviations are closed
• Leads or participates in focused deviation cross-functional investigations, improvement projects
• Reviews and approves laboratory investigations in a timely manner and ensures appropriate root cause is identified
• Provides assistance to other QA associates and assist with department trainings
• Provides support to QA management during regulatory audits
• Reviews BOMs, inspection plans, pallet patterns, calibration records and SOPs
• Performs internal audits and assist in writing reports for audits
• Maintains and revises procedures related to the quality assurance activities. Supports Annual Product Review (APR) reports by collecting batch record data, creating and maintaining data bases
• Maintain the vendor complaint process
• Maintain, monitor and provide trend analysis of DIs, LIs, CAPAs, customer complaints and change controls
• Performs special projects and/or assignments as indicated by Quality Management
• Oversee and review of Obsolete material destruction
• Perform Quality inspections on packaging line as needed
• Maintain supplier approval program
• Support/Maintain site Document Control System
• Review, approve and close out Document Change Requests
• Tracking of changes using DCC spreadsheet and supporting actions through closure
• Maintain original documentation archive and Archival of documents offsite
• Printing of new and revised documents, Issuance of forms, logbooks
• Review documentation submitted for routing in eDMS for proper formatting and accuracy.
• Load documents into an electronic Documentation Management System (eDMS)
• Route documents for approval in the eDMS
• Recall documentation for audits in a timely manner
• Performs external audits and assist in writing reports for audits
• Responsible for maintenance and revision procedures related to document control

Key Competencies (knowledge, skills, and abilities every person must possess to be successful)

• Critical Thinking — using logic and reasoning to identify the strengths and weaknesses of alternative solutions, conclusions, or approaches to problems
• Excellent customer service skills and professional demeanor at all times to interface effectively with all internal and external customers
• Excellent verbal and written communication skills
• Energetic, enthusiastic, and motivated disposition
• Attention to detail with strong organizational skills
• Ability to explain problems, solutions and make recommendations, and the ability to manage various urgent requests in a professional manner
• Ability to analyze data/trends to make sound regulatory interpretation while preparing metrics and reports
• The ability to drive projects in relation to implementation of new workflows and updates to new systems