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QA Supervisor - Complaint Management

Location Greenville, ノースカロライナ州, アメリカ合衆国 Job Id R-01305995 Job Type フルタイム Category 品質・薬事 Remote すべてオンサイト
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JOB DESCRIPTION

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

Discover Impactful work: 
As a QA Supervisor - Complaint Management​ for Product Complaints, you will be responsible for the management of a team performing product complaint investigations received from clients. By working with subject matter experts (SMEs) in the operations areas, you will focus on the compliance of these systems to ensure inspection readiness and to facilitate improvement in the investigation program. Additionally, as Thermo Fisher Scientific is focused on the customer experience, you will be communicating the status of these items with customers to ensure that their expectations are being met.  
 

Key Responsibilities:  

  • Collaborate with Subject Matter experts (SME), providing independent and objective quality advice supporting business procedures managed by SMEs.  

  • Provides Quality oversight related to continuous improvements (CI) associated with our QMS through metrics and key performance indicators.

  • Present investigation findings in review boards (Deviation or CAPA) as well as to the impacted customers 

  • Supports the Business Process Owner network by ensuring risk-based improvements to procedures to ensure that they are simple, efficient, and fit for purpose while maintaining regulatory compliance. 

  • Lead a team of personnel ensuring team’s organizational performance and succession planning  

  • Direct and prioritize the investigations team to ensure regulatory requirements, client commitments and business needs are met 

  • Foster a culture of strong employee engagement, collaboration, flexibility, and competitiveness by improving competence, industry understanding, and executional skills 

  • Administer and oversee Thermo Fisher Scientific’s investigation and CAPA computerized systems access, etc.  

  • Mentor and train the staff members on investigation process 

  • Provide investigation guidance and expertise for complex deviations to all teams on site 

  • Supports a robust regulatory intelligence system by monitoring changing regulations and ensuring that the BPO network incorporates changes efficiently and timely. 

Core Qualities and Competencies: 

  • Excellent leadership skills to motivate team to adapt to new ways of working 

  • Strive to improve the performance of the team by proactively identifying system improvement opportunities 

  • Use critical thinking and engage in problem solving 

  • Be able to perform statistical analysis when there is a large body of data 

  • Understand and employ risk analysis skills 

  • Strong communication skills to effectively interact with internal teams, regulatory authorities and clients 

  • Ability to resolve conflict within the team and in a cross functional setting 

  • Excellent organizational skills with proven track record to prioritize when timeline conflicts exist 

Educational and Experience Requirements:  

  • Bachelor’s Degree within a Science and/or Engineering field 

  • A minimum of 5 years in a cGMP quality/manufacturing role in a pharmaceutical, food or cosmetic environment  

  • Experience in management of a team in a regulatory environment 

  • Experience in cGMP principles pertaining to investigations and CAPA  

  • Expertise in technical writing skills 

  • Expertise in practical problem solving and continuous improvement projects 

  • Experience in direct communication with clients and regulatory authorities 

  • Proficient in Microsoft Suite (Word, Excel, PowerPoint) 

  • Knowledge of adult learning methodologies; ability to coach and train others 

Physical Demands: 

While performing the duties of this job, the employee is required to walk, sit, and use hands, handle or feel tools or controls, reach with hands and arms, balance, stoop, crouch, bend, talk and hear. Typically located in a comfortable indoor area.

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