All Production Line Operators are responsible for all activities associated with the manufacturing and filling operations, required to produce sterile drug products under aseptic conditions.
ESSENTIAL FUNCTIONS: Include the following. Other duties may be assigned.
Compliance with associated SOPs and training requirements
Basic understanding of personnel, equipment flow and controlled environments
Prepare for aseptic gowning qualifications. NOTE: Must have flexibility, discipline and not fall out of established limits.
Basic understanding of aseptic procedures and cleanroom behavior in controlled environments
Transport sterile components and supplies from a controlled 10000 classification environment to a 1,000 classification environment and from 1,000 classification environment to 100 classification environment.
Observation and processing of fills/rooms in #1 and #2 areas
Knowledge of documentation activities in log books, forms, MBR etc. in a legible manner as per cGMP
Break down fill rooms after fills are completed
Dispose of waste after filling process is finish: Weighing , recording and attaching data or records to Batch Record
Stocking of consumable items, such as shoe covers, gowns, scrubs, as necessary
Must be detail oriented with the ability to work within a team environment or independent if required.
Some Saturdays and Sunday (Overtime) will be required to work by the company based on the department's schedule.
Must assume any position required within the department for coverage.
Must be able to work until all cleaning activities are complete.
Insure all required documentation is completed in the fill room.
Deliver quality and quantity
Must be flexible in adapting to a work schedule that could change as a result in business direction.
ADDITIONAL RESPONSIBILITIES:
Must coordinate with packaging dept. senior operators to ensure all production activities are performed and production demands are satisfied.
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 required along with experience in pharmaceutical processing. One year pharmaceutical experience, preferably in Aseptic manufacturing.
JOB PREREQUISITES:
Ability to meet attendance standards. All full-time employees are required to work a 40 hour week. At times it may be necessary to work additional hours in order to get the required tasks accomplished to meet deadlines.
Strong communication skills.
The ability to manage multiple operations, simultaneously during routine duties.
Ability to lift weight up to 50lb.
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 50 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.
Company Overview 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.