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

• Follow aseptic/cGMP techniques.
• Operate component assembly machines and filling machines.
• Unload sterilizers and properly handle components.
• 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)
• Receive components, verify counts and assign to respective batches.
• Perform aseptic operations.
• Perform appropriate department housekeeping duties per SOP’s.
• Continually meet aseptic gowning requirements and adhere to aseptic technique principles at all times inside the Aseptic Processing Area.
• Participate in process improvements activities.

Basic Qualifications

• A 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 Requirements

• Regularly required to use hands to finger, handle, or feel objects, tools, or controls.
• Regularly required to stand and walk; climb or balance; and stoop, kneel, crouch, or crawl.
• 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.
• 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.

Physical Qualifications

• Regularly required to use hands to finger, handle, or feel objects, tools, or controls.
• Regularly required to stand and walk; climb or balance; and stoop, kneel, crouch, or crawl.
• 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.
• 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.

California Residents Only

California residents should review our Notice for California Employees and Applicants before applying.

Equal Opportunity Employer

Kindeva Drug Delivery is an Equal Opportunity/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, gender, age, national origin, disability, Protected Veteran status, sexual orientation, or any other characteristic protected by federal, state or local law.