Senior Life Science Quality Assurance Specialist

About the role

The Life Science Quality Assurance Specialist III is a senior-level employee who reports to the Life Science Quality Manager. The role will own Quality System(s) working with stakeholders in facilitating meetings, providing data from tracking and trending, leading quality and continuous improvements. The Specialist III will have the responsibility to train the organization on the Quality System(s), as well as mentoring Quality Team members. The individual will help drive change that will remediate the risks to internal and external customers.

Responsibilities

• Maintains a culture of quality awareness, teamwork, and cooperation with Quality customers.
• Provide Quality oversight, support and engagement as needed by Operations.
• Owner of Quality Management System Processes such as: Document Control Program, Change Management Program, Deviations and Nonconformances, Complaint handling and investigations, Supply/ Vendor Management, Audit Program, Validations, and Quality Metrics.
• Facilitate meetings, provide system visibility, communicate status, and facilitate closure of aging items.
• Gather performance metrics and coordinate Management review inputs from various contributing departments.
• Track, trend, and report Quality System metrics to ensure continuous quality improvements while communicating critical compliance and quality risks.
• Work cooperatively in a team environment to maintain cross functional, and cross site processes and procedural consistency for quality systems records.
• Create and implement a training program for the QMS processes to educate Quality Assurance customers.
• Perform other Quality Assurance Duties as required.

Qualifications

• Understands and applies comprehensive knowledge of quality principles and maintains current understanding of regulations.
• Familiarity or experience with the following is strongly preferred: Basic statistics, review/approval of documentation; risk tools, technical writing, and writing/reviewing/approving investigations.
• Computer Skills: Knowledge of Master Control, or similar eQMS a plus.
• Demonstrated experience and proficiency in Microsoft Office applications, Word, Excel and PowerPoint.
• Adaptability: Responds effectively to changing constraints. Good interpersonal skills and ability to work effectively and efficiently in a team environment to accomplish goals.
• Decision Making: Makes pragmatic decisions based on range of factors. Able to make decisions quickly where necessary, based on incomplete information. Demonstrates logic to back up decisions. Excellent critical analytical skills – ability to find root cause of why and issue occurred.
• Initiative: Identifies ways to improve processes/situations. Takes responsibility for improvements or solving problems. Must display eagerness to learn and continuously improve. Sets own standards above prevailing standards, shows dissatisfaction with substandard or inefficient activities.
• Interpersonal Skills: Socially capable - interacts confidently, reads the situation. Empathetic and can evaluate likely reactions. Collaborative approach.
• Results Oriented: Ability to focus on important issues only. Risk based approach. Regularly refocuses on results. Demonstrates a drive to exceed performance targets.
• Task Management: Ability to handle multiple tasks and competing priorities concurrently and in a timely fashion. Prioritizes and monitors tasks progress. Makes realistic estimates of time and resource requirements.
• Work Environment: The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions.
• Education: Bachelor’s degree (BA) from four-year college or university or Associates degree (A.A.) with four to six years related experience and/or training. OR six to eight years related experience and/or training. OR equivalent combination of education and experience.