Job Description

• 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

Qualifications

** 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.
• Professional leadership experience
• Strong knowledge of global regulatory and cGMP requirements, industry best-practices
• Strong familiarity with production operations.
• Strong leadership, project management, and technical writing.

Additional Information

What to Expect in the Hiring Process:

• 10-15 Minute Phone Interview with the Region Recruiter
• 45-60 Minute Virtual Interview with the Manager and/or Group Leader
• 30 Minute Virtual Meeting with the Site Director

Additional Details:

The position is full-time, Monday-Friday from 8 am-5 pm. Candidates living within a commutable distance of Rensselaer, New York, and the surrounding areas are encouraged to apply.

• Excellent full-time benefits including comprehensive medical coverage, dental, and vision options
• Life and disability insurance
• 401(k) with company match
• Paid vacation and holiday
• Targeted Compensation: $75-90k

Eurofins Lancaster Laboratories Professional Scientific Services® (PSS) is a global, award-winning insourcing solution that places our people at our clients’ sites dedicated to running and managing laboratory services while eliminating headcount, co-employment, and project-management worries.

We infuse our 55-year track record of scientific and laboratory operations expertise, as well as HR, and a great place to work best practices, to recruit, hire, train, and manage highly qualified scientists to perform laboratory services using our client’s quality systems and equipment.

To learn more about Eurofins Lancaster Laboratories, please explore our website www.eurofinsus.com.

Eurofins USA PSS Insourcing Solutions is a M/F, Disabled, and Veteran Equal Employment Opportunity and Affirmative Action employer.