LEAD QUALITY SYSTEMS - SITE

Company: QuVa Pharma
Location: Bloomsbury
Posted on: October 24, 2024

Job Description:

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Our Lead Quality Systems Specialist plays a vital role in ensuring the highest quality of customer service within our finance department. Once you complete our training, your responsibilities will include providing support and subject matter expertise within areas of the Quality Management System (QMS). Operates within legal and regulatory compliance, producing a quality product. Turn your passion for precision and your commitment to quality into a meaningful impact on healthcare across the US.
What the Lead Quality Systems - Site Does Each Day:

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• Oversees printing and storing of batch records
  
• Manages all GMP site records, including storing and retrieval
  
• Leads Quality System Specialist on daily tasks
  
• Acts as site Document Administrator in QMS (MasterControl)
  
• Assists QMS processes in electronic system (MasterControl)
  
• Assists during site inspections
  
• Answers, evaluates and prioritizes incoming requests from users experiencing problems with creation of documents in QMS (MasterControl)
  
• Trains users on the use of the QMS tool (MasterControl)
  
• Recognizes necessary changes to the QMS processes and makes suggestions to improve them
  
• Supports failure and discrepancy investigations and documenting investigations on process deviations
  
• Maintains compliance with FDA 503B and cGMP guidelines, P&P, USP 797, state and federal laws
  
• Assists in developing policies and procedures
  
  Our Most Successful Lead Quality Systems - Site:
  
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  • Is attentive to all aspects of the system while working to monitor and solve routine activities/issues
    
  • Uses a systematic approach in solving problems through analysis of problem and evaluation of alternate solutions; works effectively in a team environment with great organization skills
    
  • Is proficient in the use of office applications such as MS Word, Excel, PowerPoint
    
  • Demonstrates initiative and accountability in a fast-paced environment; can make decisions quickly on available information and take action
    
  • Has excellent verbal and written communication skills; good negotiating skills and influences others when conducting follow-up
    
  • Maintains a mature problem-solving attitude while dealing with interpersonal conflict, complex environments, or time demands
    
  • Works independently and follows good documentation practices and business rules for management of documents and records used in a regulated environment
    
  • Demonstrates leadership skills through example
    
  • Starts and persists with specific courses of action while exhibiting high motivation and a sense of urgency to exceed internal customer satisfaction
    
    Minimum Requirements for this Role:
    
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    • High school Diploma or GED from recognized institution or organization required
      
    • Bachelor's degree in business, Engineering, or related field plus 2 years' experience managing documents and records in a regulatory or controlled environment; or, 4 + years relevant work experience will be considered
      
    • Demonstrated performance with direct supervision of a team is required
      
    • Must be currently authorized to work in the United States on a full-time basis; QuVa is not able to sponsor applicants for work visas
      
      Any of the Following Will Give You an Edge:
      
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      • Knowledge of business computer applications (e.g. MasterControl, Documentum, SAP, LIMS, Track wise, etc.)
        
      • 2 years' experience in Quality Assurance / cGMP / FDA regulated industry
        
        Benefits of Working at QuVa:
        
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        • Set, full-time, consistent work schedule
          
        • Comprehensive health and wellness benefits including medical, dental and vision
          
        • 401k retirement program with company match
          
        • 17 paid days off plus 8 paid holidays per year
          
        • National, industry-leading high growth company with future career advancement opportunities
          
          About QuVa:
          QuVa Pharma is a national, industry-leading, FDA registered 503B outsourcing services company that provides hospitals with essential medications in ready-to-administer injectable formats that are critical for effective patient care. We are leading the way with unmatched expertise in current Good Manufacturing Practices and sterile pharmaceutical manufacturing, and the highest quality and safety standards so hospitals can more confidently and reliably focus on patient care nationwide.
          As part of our team, you'll experience being at the forefront of groundbreaking solutions, collaborating with brilliant minds, and making a tangible impact in healthcare delivery.
          QuVa is an equal opportunity employer and is committed to creating and maintaining a work environment that is free from all forms of discrimination and harassment. QuVa's Equal Opportunity Policy prohibits harassment or discrimination due to age, ancestry, color, disability, gender, gender expression, gender identity, genetic information, marital status, medical condition, military or veteran status, national origin, race, religious creed, sex (including pregnancy, childbirth, breastfeeding, and any related medical conditions), sexual orientation, and any other characteristic or classification protected by applicable laws. All employment with QuVa is "at will."
          
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Keywords: QuVa Pharma, East Brunswick , LEAD QUALITY SYSTEMS - SITE, Other , Bloomsbury, New Jersey