Room Attendant

• Uses quality tools to implement improvements including process flowcharting, Pareto analysis, correlation and regression analysis, significance tests, design of experiments, statistical process control, gauge repeatability and reproducibility, and trend analysis techniques.
  
• Monitors manufacturing processes and products for adherence to company and regulatory standards and practices. Participates in quality improvement initiatives and projects.
  
• Performs quality reviews and internal audits; evaluates data and writes reports to validate or indicate deviations from existing standards.
  
• Lead and/or support Internal and External Audits
  
• Lead and/or support test method, process and equipment validations.
  
• Support training management for quality and operations personnel.
  
• Acts as a customer liaison and processes customer quality complaints.
  
• Lead and manage quality involvement for the development of new products via process validation methodologies. Ensure the quality and operations team is trained in process validation for new products and revisions for successful product launches, transfers, and revisions.
  
• Support DMF submissions, product registrations, facility registrations, and IND submissions with the FDA and customers as needed.
  
• Assist the development of essential QS deliverables including, but not limited to complaint analysis, risk analysis, failure mode and effects analysis, NCMR, CAPA, Complaints and process/equipment/software verification/validation.
  
• Reviews and approves change requests.
  
• Work with production to document current process parameters and develop written instructions to eliminate unnecessary process variations.
  
• Participates in pre- and post-production reviews providing quality and regulatory support.
  
• Collects the required data and chart the quality goals established by the management team.
  
• Supports measuring and analyzing key metrics to monitor performance.
  
• Leads productivity improvements by providing quality guidance.
  
• Lead or guide team on NCMR, Complaints and CAPA.
  
• Works with cross-functional teams to solve production and quality problems.
  
• Lead quality and compliance by complying with all Quality Systems documentation requirements and establishing/supporting plan(s) to meet/exceed company goals for Quality that support Safety, Compliance, Six Sigma Quality, On-Time Delivery (OTD) and financial objectives.
  
• Lead change efforts to improve internal rework and scrap to improve metrics
  
• Track and trend internal and external quality metrics to proactively solve problems which involves characteristics and features of products, and documentation related to these activities
  
• Lead and develop team members to develop our best team. Ensure the growth of our positive business culture through behaviors that align with our values and leadership competencies.
  

Requirements

• Three years or more of relevant quality system experience in pharmaceuticals.
  

• Knowledge of 21 CFR Part 211 and ICH Q7-Q12 is preferred
  
• Ability to apply logic and reasoning to solve complex problems, including identifying strengths/weaknesses, locating alternative solutions and conclusions, and approaches to problems; and making high-quality, timely decisions
  
• Knowledge of quality management methods, tools, and techniques used to create and support an environment that meets the needs of the organization.
  
• Knowledge of quality management methods, tools, and techniques used to create and support an environment that meets the needs of the organization.
  
• Knowledge of pharmaceutical quality requirements for launching and sustaining new products, such as Lifecycle Management or Technology Transfer.
  
• Knowledge and understanding of federal, state and local laws and regulations affecting manufacturing practices and activities.
  
• Experience with and working knowledge of cGMP and GLP quality systems.
  
• Knowledge of procedures and tools for scheduling and controlling production runs and assuring quality deliverables
  
• Ability to conduct measurement correlation studies with the customer
  
• Ability to create final inspection information
  
• Excellent organizational skills
  
• Strong computer skills
  
• Strong interpersonal communication skills
  
• Confident decision-making abilities
  

• Bachelor s degree in Sciences or Engineering
  
• Quality or Regulatory certifications are preferred (e.g., CQE, CQA, CQM, RAC)
  

• This is a full-time position. Days of work are typically Monday through Friday, 8 a.m. to 5 p.m.
  

• Travel is primarily local during the business day, although some out-of-area and overnight travel may be expected.