Daryl Baker Email & Phone Number

Rahway, New Jersey, US

Basel, Baselstadt, CH

St. 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

Contract 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.

Analyst 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.

Responsible 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.

Amsterdam, Noord Holland, NL

• Quality 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.
• 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

Randolph 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.