Job #: 35180
Title: Senior Manager, Lab Services
Job Location: Seattle, Washington - United States
Salary: contact recruiter for details
Other Compensation: Bonus
Employer Will Recruit From: Nationwide
Relocation Paid?: Yes
WHY IS THIS A GREAT OPPORTUNITY?
You will be working for a world class organization at the top in their field. Their products directly impact people lives. JOB DESCRIPTION
The Senior Manager, Lab Services will manage the development and implementation of laboratory support activities and compliance to our ISO Quality Management System for Manufacturing, Supply Chain and R&D including but not limited to temperature monitoring, and reporting software, computerized maintenance management system, equipment performance and assessment, equipment preventive maintenance and calibration, ancillary systems, quality and troubleshooting procedures, implementation of new methods, equipment installation and operation and general use laboratory equipment. Candidate must be able to work well in a team environment or individually with minimal supervision when necessary.
This position will report to the Senior Vice President, Operations.
What You`ll Be Responsible For:
- Ensure effective operation of all laboratory equipment by serving as the single point of contact for all preventive maintenance, calibration, repairs, and troubleshooting equipment using the computerized calibration management systems.
- Manage equipment non-conformance issues per Quality System processes.
- Responsible for development of tracking procedures, establishment and maintenance of service contracts and warranties with laboratory equipment vendors.
- Perform measurement uncertainty analysis.
- Direct and coordinate the laboratory support staff and maintain an adequate inventory of research lab glassware, consumable materials and laboratory equipment.
- Provide training support to new scientific staff in the general use and function of designated instrumentation and create and refine user protocols for general use.
- Assure compliance to our ISO-13485 Management System and our Customers requirements
- Act as the Subject Matter Expert for Lab Services during FDA audits.
- Review and approve new equipment requisitions and ensure the preventive maintenance and calibration guidelines are in place before use.
- May organize and participate in vendor negotiations, product and software evaluations, tutorials and assist in facility modifications.
- May troubleshoot and repair general instrumentation
- Select, develop, and evaluate personnel to ensure the efficient operation of the function
- Setup and implement Key Performance Indicators.
What We`re Looking For:
- 8+ years of experience in a regulated lab environment.
- 5+ years of management extensive management experience with a focus on developing direct reports.
- Bachelors degree in life sciences or equivalent years of experience.
- Strong background in both ISO-9000.
- Knowledge and expertise of precision measurement methods and procedures for many different measurement types: Temperature, Pressure, Electrical, and Flow.
Good To Have:
- Experience with computerized calibration management systems, such as Blue Mountain.
- Standards applicable to in vitro diagnostics
- Lean Six Sigma certification
- ISO 13485
University - Bachelor`s Degree/3-4 Year Degree
How to Apply: