Steven Deems Email & Phone Number

Novato, California, United States

LeadershipAccountable for the daily operations in area, requiring effective communication to make appropriate decisions, trouble shooting, and schedule adherences with minimal oversightAccomplishes tasks through direct and effective coordinationProvides direction and hands-on training for staffManagement of staffLives department values and sets the standards for others to operateFosters an environment of compliance, strong work ethic and ongoing learningContributionAbility to take responsibility for complex projectsEffective interaction with peers across manufacturing to create alignment and improvementPartners with support groups (Facilities, Validation, MSAT, Quality) to complete scheduled activitiesProcess KnowledgeStrong knowledge and experience in all aspects of relevant process theory, equipment, and complianceAbility to troubleshoot, identify issues and support resolutions with technical groupsRequired to perform ongoing operational tasks in respective work areaUses scientific thinking and decision making in daily workTechnical CompetencyProven experience with relevant process, theory and equipmentExperience with process automation and functionalityAssist with review and approval of documentation including Batch Records and logbooksTechnical Documentation:Provide feedback and/or suggested changes to operational proceduresAssist in the incorporation of new technologies, practices and standards into proceduresCapable of writing and reviewing process documentsQuality and ComplianceComplete understanding and adherence to cGMP’s as related to commercial operationsInitiate and own required Corrective and Preventative actions and lead change control actionsSupport the closure of manufacturing discrepancies and change requestsCurrent understanding of FDA and EMEA guidelines, cGMP's for Manufactured Drug ProductsBusinessExperience with business systems (Process historian, LIMS, Trackwise, ERP, MES, )

Concord, California, United States

Supervise and provide leadership to the Quality Inspection Department and related processes to ensure conformance to customer specifications and compliance with relevant regulatory requirements.Responsible for compliance with and improving the corporate Quality System in conformance to FDA and ISO standards appropriate for world-class suppliers to the medical device industry with the following areas of responsibility:· Develop and supervise in-process and final inspection processes.· Manage the resolution of all product rejections and returns, internal and external, call and follow-up on Material Review Board Meetings.· Responsible for inspection department, including scheduling, prioritizing work, hiring, and assessing individual performance with respect to individual, department, and corporate goals.· Complaints/SCARs· Manage activities to ensure timely response to all customer-inquiries.· Track and manage the timely resolution of all customer inquires, open SCAR’s.Corrective and Preventive Actions:· Ensure Corrective And Preventive Action (CAPA) activities are initiated when required.· Monitor CAPA activities from initiation, through closure, and verification of effectiveness.· Audits· Internal Audits - Participate in and/or perform internal quality audits.· Third Party Audits – Participate in external quality audits and surveys from customers and regulatory agencies.· Train employees, including management, in quality processes and regulatory requirements. · Monitor internal training activities to ensure employees are trained in accordance with Pulse Systems.· Work with other departments to define, qualify, and implement Document Change Orders.· Manage the Document Control process to maintain revision control on all internal controlled documents.· Ensure that Document Change Orders are tracked and implemented in a timely manner.

Sacramento, Ca

➤ Proactively managing large multi-unit projects in fast paced environments that are often beset with a host of changing priorities, utilizing best industry practices to define project scope and objectives and ensure they are met or exceeded.➤ Dynamically leading and directing teams to complete daily assignments and verification of completed projects according to requirement, carefully documenting and optimizing workflow, identifying areas for improvement.➤ Cross-functionally collaborating with other departments to ensure processes are streamlined and efficient, managing contacts with vendors and suppliers while communicating expected deliverables.

Fairfield, Ca

➤ Ensured that product data produced met technical, manufacturing, and safety requirements, and are presented, controlled, and configured in accordance with company standards.➤ Successfully studied, analyzed, and executed, product change-overs and process optimizations, ensured standardized work across the board, applied root-case analysis to engineering problems and provided effective, rapid solutions.➤ Expertly took charge of engineering projects, as well as commissioned production lines after cleaning, ensured, engineers followed work instructions and safety requirements, enabled a sanitary electro-chemical etching process.

Pleasanton, Ca

➤ Capably led the Risk Analysis Team in the utilization of Process Failure Mode Effects Analysis (PFMEA) to identify and evaluate the potential failures of company manufacturing processes.➤ Assumed responsibility for the validation of all environmental chambers, installing data loggers to record and map temperature data for monitoring and analysis in order to comply with user requirements.➤ Ensuring quality assurance through the IQ, OQ, PQ system, studying user requirements and examining production process for Installation Qualification, Operational Qualification, and Performance Qualification.

Hercules, Ca

➤ Efficiently developed validation strategy and coordinated validation activities required to complete large scale validation projects, built a new Deionized Water system, successfully ensured FDA regulations were adhered.➤ Cross-functionally mapped and risk assessed the Shelf Life Assignment system, mapped and implemented the future state under ISO 13485 quality controls, resulting in no more product recalls and high FPY of labeled product.➤ Authored, reviewed and approved Change Control documentations for complex validation, equipment, facility/utility and/or automation changes, ensuring all mandated timelines were met under-budget.➤ Reduced cycle time by 15% of the Fill Finish System, placed gains under control using engineering upgrades, the execution of excellently developed engineering procedures, and the addition of clear ID tags throughout the system.➤ Personally designed and implemented new clamshell packaging that resulted in elimination of employee injuries and lowered assembly costs by 50%, prepared source documentation for regulatory findings.➤ Consolidated and Standardized packaging materials for top 21 reagent kit products resulting in the reduction of kit box sizes from 15 down to 8, eliminated excess packaging for a 20% reduction of package material costs.➤ Validated new product Bar Code label Software, conducted pFMEA risk assessment for the new system, eliminated software glitches and reduced Label production down time over two workstations.➤ Spearheaded the process validation of RFID Tags, used for a new instrument reagent monitoring system, developed the process from scratch, and the new system was delivered and validated on time and on budget, per ISO13485 regulations.

Hercules, Ca

➤ Capably Supervised 15 Production Technicians, maintained schedules and trained personnel, reviewed and approved Batch Records, solved day to day production problems, conducted deviation resolution.➤ Performed root cause analysis, package designs and qualification, instrument qualification, warehouse bar code implementation, validation engineering, CAPA Investigations, HPLC, EIA Assay Product Transfer, SOP procedures.➤ Expertly Led 7 Manufacturing Technicians for HIV Western Blot Lab, implemented Lab matrixes, controls and upgrades to Western Blot Production Lab and increases immunoblot pass rates by 35%, validated manufacturing processes.➤ Performed HIV protein purification, Hut cell tissue culture, bulk reagent manufacture, Column Chromatography Protein Purification, Hemoglobin enrichment, Work Instruction Revisions.