QA Specialist III - Deviations/CAPA's/Complaints

Essential Functions

• Assist in remediation and closing of Deviations, CAPAs and Complaints which includes hosting a Quality Review Board
• Manage a daily metrics pertaining to pending deviations, CAPAs, customer & client complaints to ensure on time closures
• Perform deviation, CAPA, customer complaint quality oversight and write up of client complaints to ensure root cause analysis and write up of investigation are clear and concise
• Perform qualification review for investigator and quality colleagues
• Conduct timely information gathering sessions with cross-functional departments, such as Facilities, Materials Management, Quality Assurance, and Validation, to obtain required information and data to complete the review and closure of an investigation
• Support client due diligence and Quality audits as well as regulatory inspections as SME and process owner
• Work with Quality management to implement and grow phase-appropriate quality systems that will enable cGMP manufacturing of pre-clinical to commercial products
• Support client audit requests
• Ensure no overdue training or site actions
• Support other QA teams and other functions in completion of site actions
• Provide cGMP assistance with cross-functional departments, such as Facilities, Materials Management, Quality Assurance and Validation
• Promptly notify Senior Management of potential quality or regulatory issues that may affect product quality or regulatory compliance

Required Skills & Abilities

• Excellent written and oral communication skills
• Excellent organizational, analytical, data review and report writing skills
• Time management skills are essential as QA Compliance Specialist will be required to assist with and manage multiple Deviations, CAPAs, or Complaints and adhere to assigned due dates
• Ability to respond effectively to sensitive inquiries, client inquiries or complaints as well as communicate effectively both orally and in writing with management, peers and individuals
• Ability to work effectively, exhibit a professional manner and establish constructive working relationships
• Ability to set personal performance goals and provide input to departmental objectives
• Ability to multitask and easily prioritize work
• Ability to work independently with little supervision
• Proficient in Microsoft Excel, Word and PowerPoint

Requirements

• High school or equivalent: 8 years or more experience in Pharmaceutical or other regulated Industry
• Associates Degree: 5 years or more experience in Pharmaceutical or other regulated Industry
• Bachelor’s degree: 3 years or more experience in Pharmaceutical or other regulated Industry
• Master’s Degree: 1 year or more experience in Pharmaceutical or other regulated Industry working in Audit and Inspection

Preferred Qualifications

• Degree in Biology, Chemistry or Engineering