Validation Supervisor

Job Description

The Validation Supervisor (VS) will work under the general direction and guidance of the Director of Microbiology and Laboratory Operations Management. The Validation Supervisor’s primary role is to establish validation policy/strategy to manage projects relating to VRL manufacturing processes and manufacturing equipmentand to ensure the validation deliverables meet the quality standards and requirements of company policies and all regulatory bodies that VRL is accredited with. The VS will perform job duties in accordance with GMPs, policies and procedures, and testing requirements. The VS will be responsible for training/advising of technologists and support staff and providing specialized expertise in assigned technical areas.

• Managing multiple projects to provide documented validation of primary and secondary manufacturing processes. Day to Day operation to ensure smooth flow of samples and testing.
• Establishing philosophy, structure, and scope in compliance with regulatory requirements through Validation Master Plans, policy and standard operating procedures.
• Managing the activities of approximately four direct reports to accomplish scope of work of validation department.
• Managing protocol and report development.
• Execution and approval associated with validation protocols and process validation activities.
• Evaluate and determine required validation testing.
• Coordinating contract commissioning and validation services including contract review and approval.
• Interface with internal and external clients.
• Develop and manage timelines to ensure optimum productivity.
• Knowledge of Aseptic processing and USP requirements.
• Oversees the scheduling of staff to insure production schedules are met.
• Counsels staff with regard to problems encountered in daily operations.
• Works with Quality Assurance to resolve client complaints by investigating problems, developing solutions and making recommendations to management.
• Recommends new equipment for the department.
• Ensures supplies and reagents are available for all projects.
• Performs duties in compliance with all applicable regulatory and accrediting agencies.
• Supports VRL Eurofins’ business philosophy, leadership values and ethics.
• Assures technologists are adequately trained. Provides training and technical advice to technologists and other support staff. Promotes uniformity in the implementation of policies and procedures.
• Performs technologist job duties as needed to support appropriate staffing levels.
• Works with Microbiology Testing to ensure a smooth transition from validation into a “live” environment.

Qualifications

• 4 years of microbiology validation experience.
• Bachelor’s Degree in a chemical, physical, biological science or a clinical laboratory science/medical technology program by an accrediting institution. Knowledge of regulatory requirements in both the CAP/CLIA setting as well as knowledge of FDA, and industry standards.
• Must be able to interpret and apply government and industry regulations.
• Excellent and effective written and oral communication skills, including presentation skills and interpersonal skills.
• Exceptional cross-functional team leadership skills and ability to work in close collaboration with others.
• Strong organizational and planning skills as well as strong attention to detail.
• Ability to work independently with limited supervision, adapt to change and manage multiple tasks.
• Ability to analyze, define and effectively convey difficult and complex issues in a way that accurately communicates the issues to leadership.
• Ability to problem-solve and make decisions on complex issues, often in a cross-functional team setting.
• Technical knowledge of applicable regulations.
• Effecting operations of a clinical reference laboratory.

Additional Information

Position is full-time, Monday through Friday from 8:00 am- 5:30 am, with overtime as needed. Candidates currently living within a commutable distance of Centennial, CO are encouraged to apply.

• Compensation Range: $60K- $80K, depending on experience
• 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