JOB OBJECTIVE:

To fill the position of Service Manager,for a dynamic service organization of Calibration Services (Job Title still not known), Confidential 

SUMMARY:

• Over 25 years Biotech experience
• Calibration and Maintenance SME for Inspections
• Authored and Implemented Strategies and Instructions
• Expert super - user of SAP and Blue Mountain RAM Maintenance/Calibration software
• Discrepancy and CAPA Action Item Owner
• Calibration Standards: ISO17025 and ANSI Z540
• Active Membership for Strategic Initiative Teams.3
• Analysis and optimization of Maintenance Intervals
• Active Membership for Strategic Initiative Teams
• Highly motivated and self-driven
• Mentored Technicians to develop their hard/soft abilities
• Able to analyze information and solve problems
• Strategic Partner with Customers on Projects/Initiatives
• Great written and verbal communication skills
• Proficient user of Performance Planning and Review
• Manage Vendors performance
• Analysis and optimization of Maintenance Intervals

PROFESSIONAL EXPERIENCE:

Confidential, South San Francisco

Lead Instrument Specialist

Senior Supervisor

Confidential

Senior Supervisor

Confidential

Supervisor

Confidential

Equipment Qualification Project Manager

Confidential

Supervisor

Confidential

Master Instrument Technician

Confidential

Senior Analytical Instrument Technician

Confidential

Responsibilities:

• Led, mentored and guided and mentored up to between two to ten instrument specialists, junior, senior and master/lead level instrument technicians and equipment qualification associates.
• Led monthly team meetings with teams to communicate management objectives, group performance metrics, continuous improvement measures, current and upcoming events, cross-training opportunities, technical presentations from guests and team members, safety items, etc.
• Responsible for providing feedback to technicians and associates during one on ones and on performance reviews.
• Performed walkalongs with theShadowed technicians and associates t,o providinge direct feedback on their job performance wile on the job from the following aspects:to increase awareness and emphasize importance of cGMP compliance, efficiency, safety, and customer service. Observed technicians and analyzed processes to find opportunities for process improvement and drove those process changes to realization. As a result of this practice, the technicians and analysts experienced an increase in awareness and importance of these attributes. Management also benefitted from the walkalongs because new concepts were uncovered so that processes could be improved.
• Conducted one-on-ones and performance reviews with employees.
• Encouraged employees and associates to write and follow through onexecute development plans with goals thatto increased and broadened their learning, resulting in increased. Many of the employees increased their technical knowledge and improved their customer service skills as a result.
• Enhanced existing training qualification program with distinct technical levels to provide employees with a clear vision for developing their technical skills. This program also allowed Management to distribute work assignments in support of employee development.
• Worked with my teams to continuously improve onFocused on continuous improvement of work practices by benchmarking against industry standards and implementing best practices. Attended conferences and webinars to gain knowledge about new industry standards. Fostered input from team members, customers, management, and suppliers for new ideas to continuously improvefor continuous improvement.
• Managed equipment qualification timelines to meet master plan schedules and customer timelines. Ensured the EQ team met both master plan schedules as well as customer timelines for equipment qualification.
• Enhanced existing training qualification program with distinct technical levels so that the employee would have a vision of how they would develop their technical skills. This program also allowed Management to be able to administer this program with regards to assignment of work that supported the program.

Confidential

Technical Assessor

Responsibilities:

• Performed review on all qualification and validation activities performed by the EQ group. Provided feedback to system owners as well as associates on performance.
• Performed technical review and administered quality checks for all maintenance and calibration work in both SAP PM CMMS and Blue Mountain RAM CCMS.
• Authored, reviewed and approved qualification protocols to ensure technical accuracy, compliance with company standards and manufacturer’s best practices.
• Managed maintenance and calibration vendor performance by performing thorough technical review of their work and providing feedback regarding their performance on a routine basis to ensure compliance with internal processes.
• Analyzed and optimized equipment maintenance intervals and procedures based on past and current performance, manufacturer’s recommendations and customer’s needs.
• Performed and led changes for biennial technical audits on all Confidential maintenance and calibration procedures.
• Authored, reviewed and approved qualification protocols to ensure technical accuracy, compliance with company standards and manufacturer’s best practices.
• Led the planning and coordination of QC instrumentation and software qualification to be compliant with best practices.
• Identified and drove resolutions to complex technical problems; led the effort in troubleshooting issues for equipment qualification and calibration activities.
• Designed and managed custom-built inventory and master plan database for equipment qualification using FileMaker Pro software.
• Identified and drove resolutions to complex technical problems; led the effort in troubleshooting issues for all equipment qualification and calibration activities.
• Maintained strong relationships with customers, attended customer meetings and project team meetings to ensure that customer’s needs were communicated to the team and that customer’s requests were completed on time.
• Attended customer group meetings to ensure that all feedback directed to the team was captured, analyzed, and communicated back to the team for changes to process. Asked for customer feedback after completion to ensure that the process change was working for them as intended.
• Attended project team meetings to ensure project needs were communicated to team and project requests were completed on -time.
• Provided assistance to our customers by providing input into procurement decisions for instrumentation projects. Used knowledge gained by our customers, technicians, and other sites to assist in the decision.
• Developed service level agreements with customer groups to set expectations and provide excellent customer service.
• Works well with others, seen as a strategic partner who collaborates well with others to reach shared goals.
• Highly motivated and self-driven individual with the ability to analyze information, solve problems, and work with minimal supervision to schedule, track, review, and report progress.
• Strong written communication skills with proven record in email communications, writing training documents, execution protocols, technical summary reports and deviation/investigation/corrective action/preventive action responses.
• Strong presentation skills with proven record speaking to small and large groups, including agency auditors.
• 31 years of overall work experience, including 25 years of Biotech experience