Accelerate Diagnostics
Technical Lead, Formulations
Accelerate Diagnostics, Tucson, Arizona, United States, 85718
Job Details
Level Experienced
Job Location Corporate Headquarters - Tucson, AZ
Description
Position Overview:
The Technical Lead will join Accelerate Diagnostics' operations department as a member of the consumable manufacturing team. This individual will be part of a team that manufactures reagents, participates in fill operations, and tests product in support of consumable production on a daily basis. This person will perform the following tasks without supervision: Formulation and aliquoting of reagents, per aseptic manufacturing techniques Instrument builds (fill equipment preparation) Participation in GMP aseptic filling operations and other manufacturing processes Line clearance and closeout responsibilities Cleaning/recovery of classified area and workspaces, components preparation Final issuance of raw material via QAD/Eagle Good Documentation Practices (GDP) Labeling and packaging Lot yield verification Maintaining, operating, and performing minor/basic troubleshooting, for various lab equipment including pH meters, refractometers, autoclaves, automated fillers and analytical balances Reporting process or equipment problems to CM team lead Inventory movement (stock laboratory/prep raw materials), and cycle counting of inventory Familiarity with Lean concepts (5S, Kanban, Kaizen) Equipment maintenance, calibrations and preventive maintenance (PM's) Training and mentoring team members to the above tasks Cross Train in different functions in Operations (Kit Assembly, Instruments etc.) MWI/document modifications (redlines) In-process quality control (QC) testing Execution of installation/operation/performance qualifications (IOPQ's) Subject Matter Expert (SME) for each formulation process Acting as an independent Project Lead for at least one improvement project Acting as a point-of-contact for investigations Leading and facilitating daily activities of formulation associates, scheduling additional work/tasks Collaborate with CM team lead on additional tasks/responsibilities for formulation team Performing batch record reviews and logbook reviews Compliance with all company policies & procedures, including proper disposal of chemical waste Performing all other duties as assigned by supervisor/management Qualifications
Qualifications:
Bachelor of Science Degree in Chemistry or equivalent. Other scientific degrees and/or work experience will be considered. Minimum of 6 years' experience with reagent formulating operations, per manufacturing work instructions and Good Documentation Practices (GDP) in a cGMP environment Academic and/or industrial laboratory research experience Accurate and precise measurement skills (gravimetric and volumetric) Accurate dilution manufacture techniques Aseptic technique Knowledge of chemical/reagent formulation processes Knowledge of wet/bench chemistry Excellent written/verbal communication skills Organized, meticulous, diligent
The ideal candidate will be a dependable team player with reliable attendance, passion, great communication skills, a sense of urgency to resolve issues as they arise, and an ability to keep up with key daily tasks in a fast -paced environment.
Level Experienced
Job Location Corporate Headquarters - Tucson, AZ
Description
Position Overview:
The Technical Lead will join Accelerate Diagnostics' operations department as a member of the consumable manufacturing team. This individual will be part of a team that manufactures reagents, participates in fill operations, and tests product in support of consumable production on a daily basis. This person will perform the following tasks without supervision: Formulation and aliquoting of reagents, per aseptic manufacturing techniques Instrument builds (fill equipment preparation) Participation in GMP aseptic filling operations and other manufacturing processes Line clearance and closeout responsibilities Cleaning/recovery of classified area and workspaces, components preparation Final issuance of raw material via QAD/Eagle Good Documentation Practices (GDP) Labeling and packaging Lot yield verification Maintaining, operating, and performing minor/basic troubleshooting, for various lab equipment including pH meters, refractometers, autoclaves, automated fillers and analytical balances Reporting process or equipment problems to CM team lead Inventory movement (stock laboratory/prep raw materials), and cycle counting of inventory Familiarity with Lean concepts (5S, Kanban, Kaizen) Equipment maintenance, calibrations and preventive maintenance (PM's) Training and mentoring team members to the above tasks Cross Train in different functions in Operations (Kit Assembly, Instruments etc.) MWI/document modifications (redlines) In-process quality control (QC) testing Execution of installation/operation/performance qualifications (IOPQ's) Subject Matter Expert (SME) for each formulation process Acting as an independent Project Lead for at least one improvement project Acting as a point-of-contact for investigations Leading and facilitating daily activities of formulation associates, scheduling additional work/tasks Collaborate with CM team lead on additional tasks/responsibilities for formulation team Performing batch record reviews and logbook reviews Compliance with all company policies & procedures, including proper disposal of chemical waste Performing all other duties as assigned by supervisor/management Qualifications
Qualifications:
Bachelor of Science Degree in Chemistry or equivalent. Other scientific degrees and/or work experience will be considered. Minimum of 6 years' experience with reagent formulating operations, per manufacturing work instructions and Good Documentation Practices (GDP) in a cGMP environment Academic and/or industrial laboratory research experience Accurate and precise measurement skills (gravimetric and volumetric) Accurate dilution manufacture techniques Aseptic technique Knowledge of chemical/reagent formulation processes Knowledge of wet/bench chemistry Excellent written/verbal communication skills Organized, meticulous, diligent
The ideal candidate will be a dependable team player with reliable attendance, passion, great communication skills, a sense of urgency to resolve issues as they arise, and an ability to keep up with key daily tasks in a fast -paced environment.