Pharmaceutical Quality Program Supervisor Stany Zjednoczone

Pharmaceutical Quality Program Supervisor

49_744000051578895

Obowiązki

• Work in a GMP-regulated environment to provide and assist in the implementation of quality-related activities.
• Develop a comprehensive set of quality metrics aligned with organizational goals and industry standards. This involves collaborating with stakeholders to identify key performance indications (KPIs) and defining measurable objectives.
• Collaborating with cross functional client Quality and other PSS site team.
• Collecting data from various process areas, defect reports and performance metrics. Analyze the data to identify trends, patterns, and areas of improvement.
• Generate regular investigation, training reports to provide visibility into quality performance. Manage quality improvement activities, meetings and other activities supporting the work of the departments.
• Presenting and Communicate quality related metrics, trends, and insights to stakeholders at various level of the organization. Present findings in meetings, reviews, and reports to facilitate informed decision making.
• Evaluate and managing resources and task- understanding department needs to evaluate resources needed by implementing the Capacity model system and cross-functional training.
• Assist with other aspects of quality improvement including administrative and operational support as needed.
• Drive continuous improvement efforts through monitoring/evaluation of site systems & processes aligned with GMP and FDA requirements. To ensure adherence with quality standards and best practices.
• Evaluate the thoroughness and effectiveness of the training program. Foster a culture of quality awareness and continues improvement throughout the organization.
• Provide oversight of systems to ensure compliance with internal policies, procedures, and guidelines.

QA Essential Duties and Responsibilities:

• Applies GMP/GLP in all areas of responsibility, as appropriate
• Demonstrates and promotes the company's vision
• Regular attendance and punctuality
• Ensure that the quality policy program is understood, implemented, and maintained at all levels of the organization; identify, prevent, or correct any departures from the quality system
• Perform work for both routine and non-routine work as specified by separate and applicable technical job descriptions for individual
• Develop and implement operational improvements
• Supervise others in performing client’s service requirements
• Coach, train, and develop others within the group with respect to their personal development and effective implementation of operational improvements
• Coordinate workflow and perform daily monitoring to meet TAT
• Conduct semiannual performance reviews, interview applicants, keep training records up to date for assigned employees, perform succession planning in preparation for growth
• Confront and address problems, concerns, and performance issues
• Coach and develop individuals and teams to maximize performance
• Foster motivation and morale
• Monitor and approve employees’ time worked through time-entry system
• Support and promote company policies and procedures
• Expand self-awareness and develop leadership skills as defined; attend applicable leadership training based on identified needs
• Perform and/or assign other duties as requested to ensure the smooth operations of department

Wymagania

Education Requirements:

• Preferred Masters or Minimum Bachelor’s degree in a Science / technical field such as Pharmacy, Biology, Chemistry or Engineering.

Basic Minimum Qualifications:

• Minimum of five years’ experience in the pharmaceutical industry and/or FDA experience, Quality Assurance/Compliance. 
• Experience in a leadership role within quality, overseeing quality labs. 
• Strong knowledge of global regulatory and cGMP requirements, industry best-practices
• Strong familiarity with production operations.
• Strong leadership, project management, and technical writing.

Oferujemy

• Position is full-time, Monday-Friday, 8:00am-5:00pm. Candidates currently living within a commutable distance of  Rensselaer, NY are encouraged to apply. Excellent full-time benefits including comprehensive medical coverage, dental, and vision options.
• Targeted Compensation: $75-90k
• Excellent full-time benefits including comprehensive medical coverage, dental, and vision options
• Life and disability insurance
• 401(k) with company match
• Paid vacation and holidays
• Eligibility for potential yearly Bonus & Merit-Based Pay Increases

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Eurofins USA PSS Insourcing Solutions is a Disabled and Veteran Equal Employment Opportunity employer.

Źródło: Eurofins/Praca