Aseptic Filling Technician
Kindeva Drug Delivery · St. Louis County, MO · 2 wk ago
EngineeringFull-time
About the Role
Work using sterile and good cGMP techniques in a clean room environment to assemble components and operate filling machines.
Responsibilities
- Follow aseptic/cGMP techniques.
- Operate component assembly machines and filling machines.
- Unload sterilizers and properly handle components.
- Review and perform 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 SOPs.
- Continually meet aseptic gowning requirements and adhere to aseptic technique principles at all times inside the Aseptic Processing Area.
- Other duties as assigned.
- Participate in process improvement activities.
Requirements
- High school diploma or general education degree (GED) or Associate Degree; one to three months of related experience and/or training.
- Must be able to pass and maintain Gown Certification requirements.
- All new external applicants will be required to pass an assessment test.
Qualifications
- 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.
- 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.
Physical Demands
- 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.
- Must occasionally lift and/or move up to 40 pounds.
- Specific vision abilities required 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.
- Requires bending, stooping, squatting, pull/push, and reaching above shoulder level.
- Must wear all required safety equipment and perform assigned work in a safe manner.
- Must use proper lifting techniques and be conscious of hazards in the environment.
- Must follow all GMP and safety procedures within the department.
Schedule
2nd shift: 2:00 PM – 10:30 PM