U-09 Aseptic Filling Tech

ROLE SUMMARY

Work using Sterile and good cGMP techniques in a Clean Room environment in order to assemble components and operate filling machines.

ROLE RESPONSIBILITIES

1. Follow aseptic/cGMP techniques.
2. Operate component assembly machines and filling machines.
3. Unload sterilizers and properly handle components.
4. Review and perform as required, proper accountability, documentation and quality in-process test results as required per the applicable SOP or Batch Record. (Batch records and logbooks) 
5. Receive components, verify counts and assign to respective batches.
6. Perform aseptic operations.
7. Perform appropriate department housekeeping duties per SOP’s.
8. Continually meet aseptic gowning requirements and adhere to aseptic technique principles at all times inside the Aseptic Processing Area.
9. Other duties as assigned.
10. Participate in process improvements activities.

BASIC QUALIFICATIONS

High school diploma or general education degree (GED) or Associates Degree; one to three months related experience and/or training.

TECHNICAL QUALIFICATIONS

• To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below 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.
• Position requires bending, stooping, squatting, pull/push and reaching above the shoulder level.
• Ability to read and comprehend simple instructions, correspondence, and memos.
• Ability to write correspondence.
• Ability to effectively present information in one-on-one and small group situations to other employees of the organization.
• Ability to add, subtract, multiply, and divide in all units of measure, using whole numbers, common fractions, and decimals.
• Ability to apply commonsense understanding to carry out instructions furnished in written, oral or diagram form.
• Must be able to pass and maintain Gown Certification requirements in order to perform required tasks.
• All new external applicants will be required to pass an assessment test.

PHYSICAL QUALIFICATIONS

• The physical demands described herein are representative of those that must be met by an employee to successfully perform the essential functions of this job.
• While performing the duties of this job, the employee is regularly required to use hands to finger, handle, or feel objects, tools, or controls.
• The employee is regularly required to stand and walk; climb or balance; and stoop, kneel, crouch, or crawl.
• The employee must occasionally lift and/or move up to 40 pounds.
• Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral, 
• vision, depth perception and the ability to adjust and focus.
• Cannot be claustrophobic.
• Must achieve a score of 9 or above for near vision (14”) with both eyes using a Titmus II vision tester.
• Position requires bending, stooping, squatting, pull/push and reaching above the shoulder level.
• The employee must wear all required safety equipment and perform assigned work in a safe manner.
• Employee must use proper lifting techniques and be conscious of hazards around him/her.
• Must follow all GMP and safety procedures within the department.

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