Laura Fernandez
San Leandro,CA
Summary
Resourceful Project Manager and Conformance Investigator with 19 years of combined expertise in Bayer business operations, procedures, and systems.
Overview
18
18
years of professional experience
Work History
Sr. Manager, FPM Packaging
10.2017 - 09.2018
- Managed daily activities of 25+ staff members to execute successful packaging of final product
- Collaborated with Supply Chain and support functions to meet On Time In Full (OTIF) customer commitments
- Reviewed process records for completeness and compliance
- Served as Human Performance (HuP) and Behavior Based Safety (BBS) lead
- Implemented HuP tools to minimize human error at critical process steps
- Performed routine Leader Observations
- Coached staff on BBS process, behaviors, and facilitated celebrations
Sr. Specialist, FPM Project Interface
08.2015 - 10.2017
- Site Core Team member and Department Champion for Human Performance (HuP) and Behavior Based Safety (BBS) initiatives
- Developed site-wide rollout strategy, including training content and delivery for different organizational levels
- Trained and coached Management on Leader Observations, and Conformance personnel on new Root Cause Analysis tools
- Led Defense Mapping process of production SOPs, identifying error traps and assessing critical steps
- Initiated and drove production changes through Change Control process
- Led cross-functional project teams to complete action items and meet project deadlines
- Supported internal/external audits including back-room support, Readiness Walk-throughs, and response generation and tracking
- Served as Interim Manager for 3 months. Duties included 1:1s with staff members, assessment and distribution of workload, resource allocation and escalations as needed to ensure project deadlines were met.
Principal Product Specialist
B
12.2013 - 08.2015
- Implemented Operating System in Media/Cell Culture department
- Developed standard communication strategy, performance feedback system, and Business Process Control Plans for key areas and support functions
- Responsible for Media/Cell Culture cross-processing readiness
- Team lead for cross-functional Focus DR Resolution Team
- Responsible for driving DRs to closure to support product release within 25 days, tracking DR progress and deliverables related to product release
- Efficiency of team resulted in excess of $100 million+ worth of product manufactured and released
- Managed Media/Cell Culture Discrepancy Investigation Team
- Responsible for tracking and reporting DR KPIs, managing personnel workload, and training new investigators
Sr. Conformance Specialist
12.2004 - 12.2013
- Led multi-departmental investigations for discrepancies occurring in production including Root Cause Analysis utilizing tools such as Fishbone Diagrams, 5 Whys, Is/Is Not, MEEPS
- Partnered with Quality Assurance and department managers to create Corrective And Preventive Actions that address discrepancy root cause
- Project team lead for closure of 40 KGPF discrepancies within 2 months while managing and prioritizing workload according to Supply Chain needs
- Performed periodic reviews of production Risk Assessments, internal audits of production facilities, and Job Compliance Assessments
- Completed Lean Manufacturing training and participated in Continuous Improvement Projects
- Served as Conformance Interim Manager for 3 months. Duties included: critical investigations lead, progress reporting to site leadership team,
responsible for timely closure of DRs for new product line (KG-PF/N), DR and CAPA monthly metrics reporting for Quality Systems performance
Facility PQ Project Manager
B
01.2012 - 08.2012
- Served as lead for 6 production facility Performance Qualifications (PQ) including management of 50+ supervisors and operators, management of facility readiness, proper PQ execution, and performance of thorough investigations as needed
- Coordinated qualification activities between multiple departments (EMO, Validation, QA, Production, Engineering, C&Q, Maintenance)
- Facilitated Risk Assessments for new production processes and building facilities
- Successfully completed Performance Qualifications by ensuring closure of 450+ action items, completion of facility audits, and revision or creation of documents while under stringent deadlines
- Chaired daily PQ meetings, presented PQ results to site leadership team, served as site leadership facility tour guide, and conducted trainings for all personnel accessing PQ area
Sr. Production Technician
Cell Culture
01.2001 - 08.2004
- Performed daily sampling and monitoring of bioreactors, and execution of cell separation, ultrafiltration, and blast freezing processes, including troubleshooting as needed
- Participated in revisions of SOPs and BPRs
- Project team lead for implementation of “6S/Visual Factory” principles into clean room environments
- Assisted in successful training of new technicians
Education
Bachelor of Arts - Integrative Biology
University of California, Berkeley
Berkeley, CA12.2000
Skills
- Excellent communication, public speaking, and interpersonal skills
- Highly motivated, self-driven, dependable employee
- Able to multi-task and work well under stringent deadlines
- Proficient in Microsoft Word, Excel, Dev@Com, SAP, MES
Affiliations
- Bayer Sr. Manager Business Program at Notre Dame
- Women Unlimited Future Leader Development Center
- Learn to Lead I and II
- Women's Leadership Initiative (WLI) Board Member Community Outreach Lead
- American Management Association Member
Timeline
Sr. Manager, FPM Packaging
10.2017 - 09.2018
Sr. Specialist, FPM Project Interface
08.2015 - 10.2017
Principal Product Specialist
B
12.2013 - 08.2015
Facility PQ Project Manager
B
01.2012 - 08.2012
Sr. Conformance Specialist
12.2004 - 12.2013
Sr. Production Technician
Cell Culture
01.2001 - 08.2004
Bachelor of Arts - Integrative Biology
University of California, Berkeley