Supervisor, Aseptic Core Monitoring oversees the aseptic core monitoring program and departmental personnel. The Supervisor, Aseptic Core Monitoring develops and implements procedures to the Aseptic Core Monitoring program. This position oversees the Aseptic Core Monitors who review all activities in the aseptic environment to ensure continued compliance with cGMP and leads the mentoring program surrounding aseptic technique for all aseptic personnel. This position requires expertise in all aspects of aseptic manufacturing of sterile product, ability to work hands on, strong leadership skills, and the ability to collaborate in a cross-functional environment. The individual will work closely with all departments in the manufacturing environment and reports metrics to site management on a regular basis.
- Oversee audit program of aseptic behavior inside the core during setup, formulation, fills, and sanitization processes.
- Leads open communication to all personnel in the aseptic core to provide feedback and mentoring regarding observed performance.
- Ensures immediate action is taken when non-compliance and/or undesired behavior by personnel in the facility is observed.
- Coordinates corrective act ion training based on both immediate and long-term feedback based on observations and evaluations.
- Leads process improvement program including collaboration with Operations/Facilities/Quality/Training Leadership to make recommendations for enhancements to aseptic processes, teaching/coaching, and implementation of procedures.
- Oversees daily inspection program of the physical conditions of the aseptic core.
- Review aseptic technique associated with media fill program.
- Routine presence in the Aseptic Core is required.
- Support personnel training in Aseptic Techniques and processes.
- Reports metrics and trends to site management on a regular basis.
- Assumes additional duties and responsibilities as assigned.
Company Overview Who we are?
- High School Diploma/GED required.
- Bachelor's Degree preferred, in a Biological Sciences Discipline, preferably Microbiology and minimum of two (2) years related supervisory experience in the pharmaceutical industry or
- Five yearsâ€™ experience, preferably in an FDA regulated Pharmaceutical Microbiology Laboratory with experience in Aseptic Processing experience, including proficiency in Aseptic Gowning qualifications, aseptic filling aseptic formulation and sanitization.
- Ability to gown and work daily in an aseptic manufacturing environment.
- Ability to conduct group trainings.
- Excellent oral and written communication skills
- At least two yearsâ€™ experience in aseptic processing.
- Ability to present results and interface with senior level management.
Aside from being a pharmaceutical industry leader with deep roots in the eye care community, Akorn has proven through the years, to be a company of clear vision. A vision of what it takes to continually develop and evolve in order sustain our mission, which is to improve patientsâ€™ lives through the quality, availability and affordability of our products. Along with developing and manufacturing branded and generic ophthalmics, Akorn manufactures injectable, oral liquid, optic, topical, inhalant, and animal health products. To learn more please visit our website at www.Akorn.com . Why choose us?
Akorn employees are modern day superheroes! That might sound like an exaggeration; however, when you think of it, superheroes help those in need. That is exactly what we do here at Akorn. If you choose to work with us, you are not choosing to work an ordinary job. You are choosing to make an impact in this world. You are choosing to have a career with purpose. If you are seeking a rewarding opportunity where you can make a difference for others, then put on your cape and join the team!!What do we offer?
- Competitive pay
- Growth and development opportunities
- Tuition Reimbursement
- 3 weeks PTO + Personal Days
- 9 company holidays
- 401K match
- Medical, Dental and Vision Benefit Options
- 100% Paid Maternity Leave
- Fast paced, family-oriented work environment
- Wellness Program
- Inclusive and diverse culture
- Adoption Assistance
- Flexible Spending Accounts
Akorn, Inc. is an Equal Opportunity Employer and takes pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status.
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