Aseptic Process Mentor

Starting hourly rate: $25 per hour with a $1.75 overnight shift differential. Final pay depends on experience, education, knowledge, skills, and abilities.

Responsibilities

• Monitor aseptic core to ensure continual compliance with GMPs and provide mentoring on aseptic technique with operators.
• Report metrics to site management on a regular basis.
• Conduct daily visual audits of aseptic behavior inside the core during fills and lyophilizer loading; take immediate action on non-compliance or undesired behavior.
• Partner with Production, Quality, and Training Leadership to recommend enhancements to aseptic processes.
• Communicate openly with operators and supervisors in the aseptic core to mentor observed performance and provide corrective-action training through immediate feedback.
• Complete daily inspections of the physical conditions of the aseptic core.
• Review aseptic technique associated with media fills; assist in completing documentation and final vial-count verification.
• Maintain regular presence in the aseptic complex.
• Escort non-gown-qualified individuals as needed.
• Train personnel in aseptic techniques and processes.
• Assume additional duties and responsibilities as assigned.

Requirements

• Bachelor’s degree in Microbiology or Life Sciences, or a combination of Associate’s degree and/or certificate with a focus on pharmaceutical manufacturing plus 1–3 years of related experience.
• Aseptic processing experience, including proficiency in aseptic gowning qualifications, is desirable.
• Ability to gown and work in an aseptic manufacturing environment.
• Fluency in English (speaking, reading, writing, and comprehension) to independently understand policies, procedures, training materials, and workplace communications in a heavily regulated environment.

Benefits

• 401(k) plan with company contributions.
• Paid vacation, holiday, and personal days.
• Employee assistance program.
• Medical, prescription drug, dental, and vision coverage.
• Life insurance and disability coverage.
• Wellness program.