Rates vary widely based on, but not limited to the following factors:
* Geographical location (My rates are lower in S. California, Bay Area, and Vegas as I arrange my own lodging and most expenses) * Type of manufacturing (i.e. pharma aseptic, medical devices, IVD's, electronics, nuclear, etc.) * Project deadlines * Difficulty of projects * Extent of 21CFR Part 11 involvement * Degree of assistance from client
Based on these primary assessments, the MINIMUM rates are as follows (excluding expenses):
$30/hr * ISO 9000, 9001, 9002 cert. Preparation. * Industrial Hygiene, fed. & Cal. OSHA (Title 8), and 29/40CFR. * SPC / SQC & statistics. * Validation of manufacturing equipment (minimal PLC, s/w, & comp. val). * Audits / assessment of validation, quality, and production records. * FMEA, HA, FMECA, FTA, Design Dev. and Hazard Analysis. * Metrology. * Quality Control (i.e. physical, chemical, toxicology, microbiology, PM). * SOP's development. * Procedures development (i.e. maintenance, calibration, use, etc.). * Employee training (i.e. GMP, QSR, ISO, statistical analysis, computer applications). * Production related DOE's and pre-validation characterizations. * Facility Validatons. * Cleaning validations (exluding characterization or DOE studies). * Sterilization validations (excluding characterization or DOE studies). * Quality Control / Assurance Verification Release of equipment and facilities.
$35/hr * Product Transfer from R&D to Manufacturing. * Clinical studies, support, DOE's and statistics. * MRP / ERP system development & implementation. * Test Method Validations. * Laboratory equipment validations. * Design control establishment / audit / assessment / management. * DOE / Characterization.
$45/hr * MRP / ERP systems validation. * Verification & Validation on software / computer driven devices (IVD's & Med. Dev.). * PLC validations. * Software validations. * Computer validations.
$75/hr * Enterprise / Corporate software development / implementation / validation / engineering. * Enterprise / Corporate MRP / ERP development / implementation.
I am very flexible and understanding towards positions outside of the USA. Rates will be up to 30% less in some situations.
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