This position reports to the Director of Quality and supports the manufacturing quality activities by complying with GMP requirements. The incumbent is responsible for verification, validation, qualification, implementation of manufacturing process equipment, and the following duties:
Provides leadership in developing processes, methods, and criteria for inspections (incoming, in- process, and final product).
Reviews controlled documents including batch records, QC data, results, and master batch record for accuracy.
Identifies and develops new quality metrics as needed
Identifies and resolves production and manufacturing problems or issues using quality tools and techniques such as root cause analysis, statistical analysis, and CAPA.
Installation and validation of rapid automation-based process equipment (robotic systems).
Responsible for inspection, test and calibration operations
Performs calibration (Gauges, Timers, Meters, Calipers) of tools and equipment; conducts tests on installed automation-based process equipment (robotic systems).
Initiates, and reviews change orders, deviations, and manages control of non-conforming products.
Develops engineering specifications, sampling plans, test protocols, manufacturing floor process flows, work instructions, test methods, master validation plans, and performs any other quality related activities as assigned.
Determines conformance of products by following internal procedures and Quality System Regulation.
Regularly monitors product quality by gathering and maintaining manufacturing quality metrics.
Experience in manufacturing/production and process control in a regulated industry (Pharmaceuticals, Medical Devices, Cosmetics or Dietary Supplements) highly preferred.
Good understanding of 21CFR part 820, part 700, part 11, GAMP, ISO 9001, ISO 13485 and ISO 14971.
Familiarity with automations systems, and PLC; Gage R&R, FMEA.
Sound knowledge of Quality Control, Statistical Process Control, & Capability Analysis and tools.
Proficiency in Minitab, Microsoft Office Suites and CAD Software/Solid Works.
ASQ-CQE is desirable but not required.
Knowledge of product inspection standards and sampling, advanced manufacturing, quality assurance, and pharmaceutical product development.
