Job Details

Level: Experienced

Job Location: Corporate Headquarters - Tucson, AZ

Salary Range: Undisclosed

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.