All Compounders are responsible for all activities associated with the manufacturing and filling operations, required to produce sterile drug products under aseptic conditions.
Include the following. Other duties may be assigned.
Formulate and compound sterile products under aseptic conditions.
Filling of sterile products under aseptic conditions.
Weighing and staging of raw materials. This requires pushing a kettle (on wheels) that weighs over 150 pounds.
Set up/preparation/cleaning and autoclaving components used in aseptic manufacturing operations. (Some lifting required, up to 50 lbs.) Any object greater than 50 pounds, not to exceed 100 lbs. must require the use of a buddy system. This system requires two employees to lift the object. No employee can lift any object greater than560 lbs by themselves.
Cleaning and sanitizing aseptic production areas.
Reading and understanding written instruction as detailed on production batch records.
Routine aseptic gowning practices (must qualify by passing daily environmental monitoring). NOTE: Must have flexibility, discipline and not fall out of established limits.
Must assume any position required within the department for coverage.
Must be available for overtime and weekends.
Any other duties as assigned
Assist in packaging operations as needed in the event of manpower shortages
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 or GED.
Experience in cGMP/Pharmaceutical manufacturing in a process environment
Minimum of Two years pharmaceutical experience preferably in Aseptic manufacturing.
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 in order to get the required tasks accomplished to meet deadlines.
Must be a team orientated person.
Working knowledge of the metric system used for weighing raw materials and component preparation.
PHYSICAL DEMANDS, MENTAL REQUIREMENTS, AND WORK ENVIRONMENT
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations must be made to enable individuals with disabilities to perform the essential functions.
While performing the duties of this job, the employee is regularly (more than 50%) required to stand, walk, stoop, kneel, crouch or crawl. The employee is frequently (25% to 50%) required to use hands to finger, handle or touch, reach above shoulders, talk or hear and taste or smell. The employee must occasionally (up to 25%) sit, and climb or balance. The employee must regularly lift and/or move up to 10 lbs and frequently lift and/or move up to 25 lbs and occasionally lift and/or move up to and more than 60 lbs. Specific vision abilities required by this job include close vision, distance vision, peripheral vision, depth perception and ability to adjust focus.
Mental requirements include:
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 office stress.
Ability to accurately communicate ideas, facts and technical information.
Maintain confidentiality of certain information.
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
While performing the duties of this job, the employee is frequently required to work near moving parts and exposed to fumes or airborne particles. The employee is occasionally exposed to wet, humid conditions, toxic or caustic chemicals, outdoor weather, extreme cold, extreme heat, risk of electrical shock, vibration and moderate noise.
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.
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.