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Daryl Baker personal email
Quality Assurance professional with 25 years of experience in the medical device and pharmaceutical manufacturing industries, with successful roles in start-up and consulting roles.Successful start-up roles * Talecrcris (US/Canadian FDA PAI's, no 483 observations)* Tear Science (US FDA PAI, CE Mark award)Successful Consultant roles with FDA interactions*St Judes Neuromodular (Company was under 2 consent decrees, continued operation under consultant remediation)*Hospira (Approximately 1000 QC Chem investigations as OOS/CAPA's)*Altria - Introduction of tobacco procurement operations to FDA oversightManagement• Over 15 years management and supervisory experience • Project/Operations/QC-QA management• Proven personnel hiring and training decisions, budgeting, technical management, cGMP, FDA, ISO compliance operations• Member, Executive Steering Committee and Management Review teamRegulatory Compliance leadership• FDA Notified Body experienced team member• cGMP, FDA, EMEA, CLIA and ISO 9001:2000, IS0l3485 and QSR CFR Title 21, Part 820, process and equipment validation, documentation systems and SOPs/STMs• Internal/external Quality System Auditing• FDA Form 483 reply experienceExperience in Quality systems administration• Author/editor of SOP's, STM's, technical reports • Originator and QA Approver roles; Corrective Action/Preventive Action reports (CAPA), root cause analysis and investigations Experienced in face to face customer complaints Engineering Change Requests (ECR) and Device History/Master Records (DHR/DMR), Sampling plans• Excellent verbal, written and presentation skillsQMS development/Continuous Improvement• Experienced in KPI development and tracking • Mentoring and employee development. Responsible for employee training. • Significant International experience (Brazil, Canada, Europe, Japan, etc)
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Quality Specialist, Systems & ComplianceMerck Sep 2017 - PresentRahway, New Jersey, Us
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Quality Specialist IiiNovartis Vaccines And Diagnostics Sep 2012 - Nov 2016Basel, Baselstadt, Ch -
Regulatory EngineerNypro Nov 2011 - May 2012St. Petersburg, Florida, Us• Responsible for all regulatory compliance issues for a medical device plastic molding manufacturing• Develops Processes and procedures for manufacturing, writes and approves related documentation (SOP’s, manufacturing directives, etc), reviews and approves validations• Responsible for the introduction and management of CAPA, supplier and internal audit programs -
Quality Compliance AdvisorTear Science Mar 2009 - Sep 2009Contract position as Quality Compliance Advisor for ISO 9001:2000, IS0l3485 and QSR CFR Title 21, Part 820, FDA 510K, and QSR compliance and conformance for a start-up medical device manufacturer of ophthalmological diagnostic and treatment products. Processing of CAR’s and customer complaint handling, ECR’s, DHR’s, DMR’s. Responsible for employee training. Maintain approved supplier list and perform purchase order reviews.
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Quality ManagerAltria Client Services Dec 2007 - Feb 2009Analyst of quality systems and laboratory controls covering the processing of leaf tobacco for use as a raw material in the manufacture of cigarettes. Responsibilities include the inspection of facilities and equipment of tobacco processing vendors, the establishment of quality and performance standards, and the evaluation of adherence to requirements.
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Operations ManagerTalecris Biotherapeutics Sep 2004 - Nov 2006Responsible for the hiring, training, supervision, and direction of a team of 10 analysts and supervisors, and managemet of all CLIA compliant operations of a 900K sample/year high complexity PCR plasma testing operation. Contract based position supporting the manufacture of plasma based biopharmaceutical products for the Canadian Blood Service. Winner of the “Big Team Award” (Talecris’ highest level award).Responsible for all process control, documentation, GMP conformity and deviation investigations, CAPA’s; personnel training, performance, safety, scheduling, production and production accounting; and billing management functions. Responsible for resolving contract issues and managing contract change requests. Results: exceeded all KPI expectations, with only minor cGMP/FDA audit discrepancies and zero findings in two years of operation, while meeting all production and budget goals.
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Quality Control ManagerAkzo Nobel Dec 1991 - Aug 2003Amsterdam, Noord Holland, NlQuality Control Manager, Diosynth-RTP, Inc - • Coordinate/schedule product testing operations through the Quality Control system• Control and coordination of laboratory test productionQuality Control Senior Analyst, Organon Teknika (now bioMérieux)Ensured TQM of ELISA diagnostic products. Established and maintained cGMP, FDA, CLIA and ISO compliant systems. Created/verified/validated computer software and laboratory hardware, and carried out stability and customer complaint testing.• Supervised laboratory operations for all testing (initial and stability) of all raw materials.• Developed and maintained SOP’s, Manufacturing and Operations Directives, submission of changes and justification of changes to Change Review Board (CRB), and follow-up audits.• Performed and supervised wet chemistry testing, spectroscopy, TLC, TOC, and GC, USP and EP compendial testing, and assay and instrument troubleshooting• Coordinated method transfers and implemented new testing methods -
CaptainUs Air Force Jun 1978 - Nov 1989Randolph Afb, Tx, Us• Graduate of USAF Clinical Laboratory course, serving four years as Clinical Laboratory specialist• Commissioned, and given leadership responsibilities in numerous operations and staff assignments. planned, orchestrated, and evaluated large-scale logistics movements, managing people, resources, and time. • Junior Officer of the Quarter for Seymour Johnson AFB, July 1986.• Commanded Aircraft Maintenance Unit (AMU), responsible for 200 assigned people and 25 assigned aircraft.• Controlled Maintenance Management Division. Supervised 30 individuals, entrusted with flying hour program reporting, budgeting, computer operations, and facilities.• Project Manager for installation and operation of CAMS computer system. Organized and supervised installation, training and operation of system utilized by approximately 2000 people.
Daryl Baker Skills
Daryl Baker Education Details
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Bs, Bowling Green State UniversityMedical Laboratory Science
Frequently Asked Questions about Daryl Baker
What company does Daryl Baker work for?
Daryl Baker works for Merck
What is Daryl Baker's role at the current company?
Daryl Baker's current role is Quality Specialist, Systems and Compliance at Merck.
What is Daryl Baker's email address?
Daryl Baker's email address is da****@****tis.com
What schools did Daryl Baker attend?
Daryl Baker attended Bs, Bowling Green State University.
What are some of Daryl Baker's interests?
Daryl Baker has interest in Kayaking, Backpacking, Hiking, Camping, Referee, Tennis, Level 4 Coach, Ice Hockey, Triathlon.
What skills is Daryl Baker known for?
Daryl Baker has skills like Capa, Fda, Gmp, Sop, Six Sigma, Quality Control, Process Improvement, Validation, Medical Devices, Quality System, U.s. Food And Drug Administration, Pharmaceutical Industry.
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