Who Run It?
From coordinating town hall meetings to making sure everyone has the most up to date business related info, this person is the behind the scenes mastermind that keeps the site and site's leader on point.
Who Is Mary Hollis?
This type of head covering is required to cover hair and ear before entering the cleanroom.
What is a bouffant?
This role calibrates critical equipment like balances, sensors, thermometers, and pressure guages.
What is a Metrology Technician?
An employee reported that safety goggles were not availabe in the production area. The company promptly ordered additional goggles and installed a dedicated storage cabinet for PPE.
What is a Corrective Action?
Before starting any maintenance on energized equipment, this MUST be done, verified and key kept with you at all times.
What is Lockout/Tagout (LOTO)?
Innovation in Birmingham and across the Vancouver RDI sites runs through this leader's pipeline. Got a new idea? They're already three steps ahead
Who is Katara Shaw?
Before entering the gowning room, this must be removed even if you swear, "It's just lip balm"
What is makeup?
They don't carry a clipboard, but they know who's in the building, who shoudn't be, and when someone tailgates into a restricted area.
Who is security?
Following a near miss incident in which a worker nearly slipped on a wet floor, the facility implemented a new policy to immediately post warning signs and conduct regular inspections of floor conditions.
What is a Preventative Action?
What is evacuate the building?
Whether it's raw materials coming in or finished goods going out, this person is the reason the site isn't standing around waiting on a shipment
Who is Corey Barron?
This alcohol based solution is used to sanitize gloved hands before entering classified rooms
What is 70/30 IPA
When the building needs balacing, the BAS triggers and alert, or the chillers cry for help, this is who shows up.
What is a Facilities Technician?
A review of production records indicated that several operators were not following the established SOPs, leading to inconsistent product quality. Additional training sessions were conducted to reinforce the importance of adhering to SOPs.
What is a Corrective Action
If you spill a chemical, even a small one, this is your first step
When HR matters move beyond PTO requests and into serious territory; policy changes, performance issues, or leadership transitions, this regional powerhouse steps in with calm authority and clear direction.
Who is Marsha Robinson?
This level of gowning requires personnel to wear the following: Scrub suit, hair net, facemask, glove liner, powder free nitrile gloves, a Tyvek lab coat and an additional pair of shoe covers.
What is Level 2 Gowning?
Before any equipment is used or touches product, this person is responsible for completing the Equipment Action Form (EAF) and obtaining all required signatures.
Who is the Equipment Owner?
After a batch was found to be contaminated due to improper cleaning of equipment, a new cleaning protocol was developed and implemented to ensure all equipment is thoroughly cleaned before use.
What is a Preventative Action
This system is used to monitor and control building air handling, pressure, and HVAC performance in real time.
What is the Building Automation System (BAS)?
From chemical spills to tornado drills, badge access to biohaards, this person is the quiet force making sure the site statys safe, secure, and compliant.
Who is Sam Sims?
After cleaning or using GMP equipment,m this action must be taken immediately and accureately or the regulators will come knocking.
What is signing the Equipment Logbook
This role performs method driven testing on in process and final products, interprets results against validated specifications, and ensures any Out Of Specification (OOS) results are reported per GMP protocol.
What is a QC Analyst?
A routine inspection revealed that several temperature sensors in the storage area were malfunctioning, leading to potential product spoilage. The sensors were replaced, and a new maintenance schedule was established to regularly check their functionality.
What is a Corrective Action?
Whether it's a leaky pipe, faulty light, or equipment issue, this system must now be used to submit a facilities work request
What is SAP?