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Aseptic Core Monitor- 1st Shift

Akorn, Inc. Somerset, NJ
  • Posted: 28 days ago
  • Full-Time
  • Benefits: 401k, dental, life_insurance, medical, vision
Job Description

 

SUMMARY
Under the general supervision of the Supervisor, Aseptic Core Monitoring, the Aseptic Core Monitor oversees all activities in the aseptic environment to ensure continual compliance with cGMP and provides mentoring on aseptic technique for all aseptic personnel.  This position requires expertise in all aspects of product manufacturing, 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 aseptic manufacturing environment.  
 
ESSENTIAL FUNCTIONS:

  • Excellent oral and written communication skills
  • Aseptic Gown Qualification
  • Media Fill Qualification
  • Maintain First Air and Good Aseptic Technique
  • Complete daily visual audits of Aseptic Behavior inside the core during setup, formulation, fills, and sanitization processes.
  • Communicate openly to all personnel in the aseptic core to provide mentoring regarding observed performance.
  • Take immediate action when non-compliance and/or undesired behavior by personnel in the aseptic core is observed.
  • Provide corrective action training based on visual audits by providing immediate feedback.
  • Navigate, Manage, and Mitigate Aseptic Risk
  • Partner with all cross functional groups to make recommendations for enhancements to aseptic process.
  • Complete regular inspections of the physical conditions of the aseptic core including but not limited to floors, ceilings, doors, and walls.
  • Daily presence in the Aseptic Core is required when possible.
  • Responsible for training personnel in Aseptic Techniques and processes.
  • Assumes additional duties and responsibilities as assigned.

 

Qualifications :

 

QUALIFICATIONS:
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.  The requirements listed are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
EDUCATION AND EXPERIENCE:

  • High School Diploma or GED
  • Degree preferred, in a Scientific Discipline, preferably Microbiology
  • Minimum of 1 year experience in Aseptic Processing, including proficiency in Aseptic Gowning.
  • Equivalent combination of education and experience acceptable

 
JOB PREREQUISITES:

  • Ability to meet attendance standards.  All full-time employees are required to work a 40-hour week, most of which has to be during “regular” business hours. At times it may be necessary to work additional hours, or shifts, in order to get the required tasks accomplished to meet deadlines.
  • Have a thorough knowledge in applicable FDA/cGMP guidelines related to Aseptic Processing, including 21CFR 211 and PIC/s GMP Guide Annex 1.
  • Ability to present results and interface with senior level management.

 
SAFETY REQUIREMENTS:
Safety glasses and safety shoes. The ability to gown and work safely in an aseptic manufacturing environment.
 
 
PHYSICAL DEMANDS AND WORK ENVIRONMENT:
While performing the duties of this job, the employee is regularly required to sit, stand, walk, talk and hear.  The employee is required to use hands to finger, handle, or feel.  Specific vision abilities required by this job include close vision for written work and PC use.
 
Mental Requirements include:

  • Ability to hear accurately the spoken word with moderate office noise or plant noise
  • Ability to apply deductive reasoning and understand complicated issues
  • Ability to receive instructions and follow work rules and company policies
  • Ability to follow safety and security practices
  • Ability to meet deadlines and effectively deal with stress
  • Ability to accurately communicate ideas, facts and technical information
  • Maintain confidentiality of certain information

 

Company Description
Our Company

Akorn, Inc. is a niche pharmaceutical company that develops, manufactures and markets generic and branded prescription pharmaceuticals as well as animal and consumer health products. We specialize in difficult-to-manufacture sterile and non-sterile dosage forms including: ophthalmics, injectables, oral liquids, topicals, inhalants, and nasal sprays. Akorn markets its products to retail pharmacies, ophthalmologists, optometrists, physicians, veterinarians, hospitals, clinics, wholesalers, distributors, group purchasing organizations, and government agencies.

EEO Statement

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.

Akorn, Inc.

Why Work Here?

Competitive pay, excellent benefits, training, family environment, excellent opportunity for advancement!

Our Company Akorn, Inc. is a niche pharmaceutical company that develops, manufactures and markets generic and branded prescription pharmaceuticals as well as animal and consumer health products. We specialize in difficult-to-manufacture sterile and non-sterile dosage forms including: ophthalmics, injectables, oral liquids, topicals, inhalants, and nasal sprays. Akorn markets its products to retail pharmacies, ophthalmologists, optometrists, physicians, veterinarians, hospitals, clinics, wholesalers, distributors, group purchasing organizations, and government agencies. EEO Statement 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.

Address

Somerset, NJ
08873 USA

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