Frederick Starkovich Email & Phone Number

Carlsbad, California, United States

• Managed and investigated non-conformances, collecting data to support root cause analysis to help improve processes and customer quality.• Assisted in the management of customer complaints and participated in investigations to better improve customer satisfaction.• Contributed to the implementation of CAPAs to address quality issues and prevent their reoccurrence. • Drove the execution of annual management review, preparing data and performing analysis to identify trends and areas for improvement. Proposed specific ideas to improve these areas and better prepare the business for the future.• Assisted in external audits to ensure that the quality and operational processes are in line with applicable standards and regulations.• Performed regular walkthroughs to ensure continued compliance to organizational standards and applicable health, safety, and quality regulations.

San Diego, California, United States

Oversaw a team of 28 QC scientists, scheduling across two campuses and up to four labs and ensuring that the labs remained production- and audit-ready while operating 24/7, including managing equipment and reagent calibration and expiration dates• Led execution of several high-risk CAPAs and performed/prepared root cause analyses and action plans for presentation to senior director-level stakeholders.• Led preparations for internal and external audits and ensured compliance with ISO 13485:2016 and other relevant regulations.• Reviewed, scheduled, and implemented validations of test methods, materials, and new equipment.• Assisted in the creation of a new stability testing program to establish shelf life for an existing EUA product and future NPI initiatives.• Investigated and reported on historical data and discrepancies including shortcomings of prior validation efforts, discrepancies between previously reported numbers and data-justified conclusions, and specification changes for subassembly testing from analyzing four years’ worth of data.• Wrote and reviewed change orders ranging from minor administrative edits to major changes impacting site procedures and processes.• Communicated effectively, escalating obstacles to shift supervisors and managers in real time.

• Owned the Non-Conforming Material Reports program, ensuring that QC actions were completed in full and on time for 30-50 NCMRs per month and implemented metrics to track performance and material disposition.• Owned the intradepartmental process improvement program to improve team performance, assessing 25-60 suggestions per month and driving implementation of 10-30 per month.• Overhauled Quality Control test protocols to prepare for the relaunch of the AcculaTM Flu A/B Test to align with current practices and worked with Technical Operations and ensure effective training of QC personnel for live virus handling and sample preparation.• Reviewed and executed change orders for test protocols, validation procedures, and standard operating practices prior to approval.• Executed and reviewed documentation of validation and verification procedures for finished goods, subassemblies, and test methods prior to approval and use in a production environment.• Performed RT-qPCR testing of subassemblies in accordance with testing protocols and performed data analysis during final review.• Performed and led testing for accelerated and real-time stability testing pursuant to ISO 26340:2015 and CLSI EP25-A and prepared results for presentation to site executive leadership team.

• Performed final release QC Testing and final document reviews during a scaleup from one line producing one thousand tests per month to 15 lines producing more than two million tests per month.• Provided training to new hires as the department grew from 30 to 100+ employees in under six months.• Performed RT-qPCR testing of subassemblies in accordance with testing protocols and performed data analysis during final review.• Executed and documented validation testing to approve production of new materials and processes.• Supported and performed weekly and monthly metrics to report out departmental KPIs.