The quality control aseptic coaches are expected to be on the floor, in real time, observing and coaching aseptic operators in proper aspeticc technique. Individuals need to have experience and knowledge of the aseptic environment and proper aseptic technique, they will also need to have good people skills as they will be correcting aseptic behavior as it is observed.
Work on the floor in the aseptic area, observing and hands on coaching operators on proper gowning and aseptic technique.
Investigation support - To provide on-the-floor for investigations in classified areas.
Support Media Simulations Quality on-the-floor to observe media fills and aseptic behaviors and document as part of the validation package.
Support aseptic behavior audit program by observing aseptic behavior and documenting on the audit forms.
Support positive feedback program for aseptic operators.
Supply feedback to operators and monthly and ongoing updates with training on aseptic techniques based on observations observed for the month.
Operations aseptic personnel, operations supervisors, aseptic quality supervision.
EDUCATION AND EXPERIENCE
Degree in a science is required.. Biology, Microbiology or Chemistry is preferred.
- At Least 4 years of Pharmaceutical Experience
- At least 2 years of clean room experience
TECHNICAL SKILLS REQUIREMENTS
2+ years' experience in a clean room.
Strong Leader Behaviors
o Willing to lead by example and jump right in
o Demonstrated desire to understand how things work
o Strong sense of ownership
o Collaborative/Active Listener
o Independently, with minimal guidance, consistently produces quality work.
o Must be able to work in a team environment within own team and interdepartmental teams.
o Must have effective written and oral communication skills.
PHYSICAL POSITION REQUIREMENTS
Individuals must be able to gown and enter the aseptic area
Able to work shift work 0600-1800 or 1800-0600
Able to work weekends and Holidays per the Pharmaceutical operations schedule (A1/B1 A2/B2).
The work weeks fluctuate from week to week. 3 days on 2 days off pattern one week and the next week 2 days on 3 days off. The long week roughly 48 hours will be worked and the short week 36 hours. OT rate no available. Flat rate for all hours over 40.
There will be morning and night shifts; 12 hours shifts either 6am-6pm or 6pm-6am.
Every other weekend is required, if scheduled on a Holiday they are expected to work, no exceptions.