Kais Shirgul

Senior-Level Engineer / Quality Assurance

ad4sck@r.postjobfree.com • 510-***-****

LinkedIn URL • Alameda, California 94502

Summary

Results-focused, customer-centric, innovative laboratory leader with expertise in all aspects of lab operations, implementation of GMP through application of GDP, supporting and training end users, and installing, demonstrating, and developing tailored assays and training to individuals and groups. Excellent interpersonal skills with ability to quickly build and maintain strong relationships with all levels of organizations, partners, and customers. Lab experience includes ELISA, cell culture, spectrophotometry, chromatography, gel electrophoresis, analysis of gene expression via enzyme kinetics, western blotting analysis, reporter gene analysis, and immunostaining.

Areas of Expertise

Laboratory Operations

Leadership & Team Building

Data Analysis

GMP / GDP / GxP

Customer Service & Support

Project Management

Biomedical / Pharmaceutical Industry

Staff Training & Development

Issue Resolution

Qualifications Summary

●Extensive experience and certification on IQ / OQ / PQ and repair of Mass Spectrometers and HPLC, UPLC, UPLC2, SFC / SFE, and Auto Purification equipment in GMP and clinical environments as well as implantation of software environments.

●Innate ability to resolve a wide range of complex problems using in-depth evaluation of competing factors, acquired expertise, and company’s policies and procedures in imaginative yet practical fashion.

●Excellent project manager and team leader using strong conceptual and tactical skills to motivate teams to produce high quality results on time and within budget.

Career Experience

GILEAD, Foster City, California 04/2022 – Present

Empower L2 Support

Provide Level 2 (L2) technical expertise in identifying, evaluating, and developing Empower and procedures that leverage system capabilities and meets user requirements.

Perform Empower maintenance tasks including LACE maintenance, account maintenance and periodic review of accounts and LACE forms.

Maintain the Empower system in a state of GMP compliance to ensure data integrity by following all related SOPs as they pertain to support duties.

Manage and complete all SPARC tickets in a timely manner related to:

1) Troubleshooting instrument connectivity issues, rebooting LACEs, custom field calculations, and optimizing processing methods.

Familiarity with Method Validation Manager in Empower, able to assist users with troubleshooting errors.

Troubleshooting Citrix connections as related to Empower, reset a Citrix profile.

Work directly with L3 (level 3 administrators) to resolve any issues/requests escalated to the L3 team. Contribute to the support and maintenance of operating procedures (SOPs and Work Instructions) pertaining to Empower by reviewing updates to documents as requested by the validation lead/system manager. During Empower upgrades and/or enhancements, perform development testing and support user acceptance testing, as well as LACE replacement and upgrades. Identify opportunities for improving Empower functionality and performance and provide recommendations to the system manager. Identify opportunities for streamlining Empower business processes to improve efficiency and compliance and provide recommendations to the system manager.

VERTOSA, Oakland, California 10/2019 – 12/2020

Lab Director

Administered the daily scientific and technical operations for manufacturers of effective and reliable active ingredients for infused product makers. Ensured lab facility operates in alignment with regulatory provisions of the government and organization. Led, formulated, and implemented strategic vision for further increasing the value of lab programs and mission. Attracted, developed, and retained the highest quality of scientific talent to test ingredients and finished products to ensure correct composition and to identify any health or quality control issues needing to be corrected. Set expectations towards institutional priorities, outcomes, and performance. Led implementation and formulation of infrastructural improvement strategies. Managed financial performance of lab and identified and implemented appropriate strategies for reducing costs and improving quality of service.

●Achieved GMP and Organic certification through GxP implementation, gaining acceptance by other organic manufacturers to increase potential revenues.

●Increased product quality, reliability and consistency with the addition of new technologies such as microfluidizers for complex emulsions and implementation of a new filtration process on the back end.

●Qualification and Validation processes developed and implemented for products, processes, and instrumentation, increasing efficiency by assuring better quality throughout manufacturing cycles.

BAS RESEARCH, Berkeley, California 8/2018 – 7/2019

General Manager, 2/2019 – 7/2019

Oversaw overall operations of California’s first licensed manufacturing company developing advanced, science-driven cannabis oil and extraction services, ensuring safe and secure operations through development, implementation, and maintenance of Company Safety and Security Programs. Built company image by collaborating with customers, government, community organizations, and employees and enforcing ethical business practices. Increased management’s effectiveness by recruiting, hiring, and training quality staff, partnering with Human Resources to achieve optimum employee levels while minimizing overhead to meet planned budget. Developed strategic plan by studying technological and financial opportunities, presenting analysis, and recommending objectives. Coordinated efforts by establishing procurement, production, marketing, field, and technical services policies and practices and coordinating actions with corporate staff.

●Spearheaded GMP Implementation (SOPs and training programs) and developed Quality Control and Quality Assurance guidelines to ensure raw materials and finished products meet and exceed company standards.

●Key contributor to Company executives and senior staff in developing long- and short-term planning, policies, programs, and objectives and coordinating departments to accomplish goals of manufacturing plans.

Extraction Manager, 8/2018 – 2/2019

Oversaw all production, quality assurance, operations, training, safety awareness, and personnel at cannabis extraction facility. Interviewed, hired, and trained required extraction laboratory personnel to meet production requirements, consistently achieving quality end products with repeatability. Created new and improved product formulations while ensuring regulatory compliance, including safety, environmental, and document control requirements. Ensured equipment reliability throughout production process. Supported organization by ensuring operations efficiency by implementing and consistently improving cost reduction strategies. Investigated all adverse events, errors, and complaints, documenting investigations and determining root cause.

●Streamlined extraction workflows, including development of SOPs, documentation, training, and selection to raise quality of operations and meet financial and operational goals.

●Met aggressive extraction milestones each month of operation while ensuring compliance with State regulations and testing requirements.

THINK SURGICAL, Fremont, California 12/2017 – 8/2018

Field Service Engineer

Applied engineering and biomechanical principles for company developing, manufacturing, and marketing active robotic surgical systems for orthopedic surgery. Performed installation, repair, and maintenance for medical equipment. Traveled to meet customers and performed troubleshooting of problems. Responded to service calls to perform onsite repairs and provide technical support services. Installed new clinical equipment and assisted in planning and purchasing of needed equipment. Tested functionality of equipment by taking detailed accuracy, selectivity, and sensitivity measurements. Performed ongoing preventative maintenance, made routine inspections, and conducted in-service training with customers.

●Provided quality customer service, communicating job progress to managers, resolved customer relationship issues, and assisted in implementing equipment changes according to customer laboratory policies and practices.

●Invited to attend American Academy of Orthopedic Surgeons conference in New Orleans (2018) representing Field Service Engineers in the industry.

EUROFINS (GENENTECH SSF), South San Francisco, California 6/2016 – 12/2017

Equipment Qualification Engineer

Provided development and implementation and equipment qualification support to project teams developing drug delivery devices for parenteral pharmaceutical therapeutics at Genentech for global market leader in testing and laboratory services. Developed SOPs, work instructions, and related documents and performed troubleshooting and other sustaining activities to maintain proper functions of automated solutions. Supported cross-functional departments in coordinating and executing developmental events and new product and process development. Identified best approaches for effective and efficient data management for process development and commercialization.

●Implemented and maintained Roche Pharm Quality Policy Quality System (PQS), creating local PTDU-D procedures and templates to ensure alignment with current versions of PQS and best practices.

●Utilized technical expertise to resolve issues arising from internal quality assessments/ audits, regulatory inspections, and notified body interactions by preparing responses and corrective actions.

●Documented and reviewed discrepancies, change, and risk management documents for PTDU-D an Devices teams.

●Collaborated with Device Engineers and Laboratory staff to identify and define critical project steps.

GILEAD SCIENCES, INC., Foster City, California 10/2015 – 5/2016

Lab Support Specialist / Administrator (Empower)

Performed Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) of all lab computers, workstations, servers, and software in a GMP environment as a critical component of Quality Assurance (QA) for research-based biopharmaceutical company. Provided priority support for all IT Lab issues including instrument connectivity, data backup, an computer setup, Maintained inventory of laboratory IT equipment and ensured security and upkeep of all connected devices. Partnered with lab employees and vendors for facilities installation and maintenance of computer connected equipment. Managed and optimized basic ITIL Service Operations including Incident Management, Event Management, Request Fulfillment, Problem Management, and Access Management.

●Served as 1st level contact and conveyed resolutions to customer issues.

●Utilized understanding of Qualification and Validation documentation to integrate third party applications and services into the lab environment.

●Managed multi-vendor software systems (Empower) and instruments across entire campus.

WATERS CORPORATION, Pleasanton, California 4/2008 – 5/2015

LC / SFC / MS Systems Engineer

Supported customers onsite in a variety of labs providing LC / SFC/ MS support including onsite installation, implementation, maintenance, and repair of company and multi-vendor systems solutions. Installed and optimized hardware / software / network products and configurations at customer sites. Diagnosed and resolved product performance problems and performed maintenance and repairs. Ensured customer satisfaction by advising customers on preventive maintenance and configurations. Proactively responded to potential equipment issues to prevent unplanned interruption of customers’ business. Delivered fully integrated solutions comprised of peripherals, communications, operating systems, and applications software. Trained other field engineers and customers in solutions.

●Promoted to LC / SFC / MS Systems Engineer from initial Field Service Engineer position.

●Provided IQ / OQ / PQ of HPLC / UPLC, Auto Purification systems, and Mass Spectrometers.

●Continually educate customers on new technology and proper use of instrumentation and associated data acquisition systems as member of Training Development Group and SFC Business Development Group.

Additional experience as Associate II, Manufacturing – BT Antigen Purification at Chiron / Novartis (2006-2008), as Science Research Assistant – Level II at UCSF (Fisher Lab) (2005-2006), and as Bio Technician – Highly Advanced at Genentech (2004-2005).

Education

Bachelor of Science, Molecular Cell Biology

San Francisco State University, San Francisco, California

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